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Bone Plating in Patients with Type III Osteogenesis Imperfecta: Results and Complications

William J Enright, MD and Kenneth J Noonan, MD


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Abstract
The results of bone plating in four children (6 femurs, 2 tibias) with osteogenesis imperfecta type III were analyzed. Average age at time of operation was 44 months. In three of the femurs, multiple platings were performed for a total of 13 bone platings in the eight bones studied. Average time to revision following plating was 27 months. Indications for revision included fracture (6), deformity (3), hardware failure (3), and nonunion (1). Other complications included one case of compartment syndrome. All eight bones were ultimately revised to elongating intramedullary Bailey-Dubow rods. Bone plating in skeletally immature patients with osteogenesis imperfecta does not provide better outcome than elongating rods. Complications from bone plating leading to revision, such as refracture or hardware failure, are higher than in those children managed with elongating rods, as previously reported in the literature.
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INTRODUCTION Osteogenesis imperfecta (OI) is a group of inherited disorders caused by defective type I collagen synthesis. Using the Sillence classification, one can determine the type of OI based on clinical, radiographic, and genetic findings.13 Patients with OI can suffer from frequent fractures and deformity of the long bones during development, resulting in impaired ambulation. The goal of orthopedic surgery for OI is twofold: Reduce the incidence of fractures and correct long bone deformity. Contemporary surgical options for deformed bones in OI include osteotomy and stabilization with non-elongating nails (Rush rods, flexible nails), elongating nails (Bailey- Dubow, Frasier-Duval), and bone plating.14,7,8,10,14,15 Elongating rods allow for growth of the bone, thereby decreasing the number of repeat operations. The advantages of elongating rods over fixed intramedullary rods include benefit to growing bones, lower incidence of re-fracture, and longer time to reoperation.4,5,11,12 There is also evidence that suggests that elongating rods used in the femur do not require revision as often as those placed in the tibia.16
At our institution, we have utilized plate fixation for stabilization of osteotomies in young patients with severe OI. Plate fixation was initially appealing in this group of patients given the age of the individuals and the difficulty of placing expandable rods in small bones. In addition, the treating surgeon felt that these rods were too large for the smallest children, thus resulting in stress shielding and bone atrophy. The purpose of this study is to review our experience in this small but select group of patients.
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MATERIALS AND METHODS


This study is a retrospective review of all patients with osteogenesis type III treated with bone plating for correction of deformity or treatment of fracture. All operations were performed by the same pediatric

orthopedic surgeon between 1994 and 2001. Inclusion criteria for this study were a diagnosis of type III osteogenesis imperfecta, history of bone plating, and recent clinical follow-up. After review of the medical files of all patients treated for osteogenesis imperfecta at the University of Wisconsin Hospital and Clinics, we were able to find four patients who had undergone at least one bone plating as treatment for fracture or deformity. Clinical records and imaging studies were reviewed. We recorded the indications for initial plating, types of plates and screws used, time to evidence of healing on radiograph, time to revision, indications for revisions, hardware used in revision (plate or rod), number and location of fractures following each plating, complications including hardware failure, and number of revisions for each bone. Regarding the measurement of time to fracture and time to revision, the authors considered each plating separately. There were cases of sequential platings of the same bone in patients where initial plating was revised with further plating. Initial plating was considered as the start point for this study, and revision with expandable rods was considered the end point.
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RESULTS All four patients were diagnosed with osteogenesis type III using the Sillence classification.13 There were three males and one female, ranging in age from 14 to 82 months (44.7 months mean age) at the time of surgery. Ages ranged from five to eight years (7.7 years mean age) at last follow-up. The average time from initial plating to final follow-up period was four years.
Thirteen bone platings were performed on eight bones. The eight bones included six femurs and two tibias. Three of the femurs underwent multiple platings before being ultimately revised to Bailey-Dubow rods. Of these three femurs, two were plated twice, and one femur was plated four times for a total of 13 platings. All platings were separate operations. No two bones were plated at the same time. The indications for initial plating of the eight bones included fracture and deformity. Of the six femurs, four were plated because of fracture, and two were plated for correction of deformity. Of the two tibias, one was plated for correction of deformity and the other because of fracture. All eight bones ultimately required revision. Three of the femurs underwent further plating for revision, while the two tibias and three other femurs were revised to Bailey-Dubow rods. Indications for revision included fracture (6), deformity (3), hardware failure (3), and nonunion (1). Rate of fracture following plating was 46% (six fractures). Location of fracture was distal to the plate in two cases, under the plate in two cases, and through the plate in two cases. In the two cases of fracture through the plate, fracture of bone with broken plate was considered the reason for revision and also considered a complication (Figures 1 and and2).2). The average time to revision was 27 months (range 4 to 71 months). The average time from initial plating to final revision with Bailey-Dubow rods was 42 months (range 9 to 89 months) for all bones.

Figure 2

Radiograph showing screw pull-out. Note the proximal and distal cancellous screws have pulled out, allowing the plate to displace from the bone and leading to hardware prominence. The complication rate in these patients was 69.2% (9 plates). The most common complication following plating was screw pull-out. Screw pull-out was seen following plating in five cases. One case involved multiple screws and required revision for stabilization. Two fractures through the plate were seen, and these underwent revision. Bending of two of the plates was observed. Of these nine complications, three instances of hardware failure led to revision: Screw pull-out required revision in one case, and two fractures went through the plate as mentioned above. Complications are listed in Table 1.

TABLE 1

There was one case of compartment syndrome following plating of a tibia, which required fasciotomy. There was one case of nonunion in a femur. This nonunion was noted five months after the initial plating and was revised with bone plating seven months after the initial operation. There were three instances of prominent hardware, one of which was symptomatic.
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DISCUSSION Bone plating is an option in the treatment of fracture and deformity in children with osteogenesis imperfecta. Previous studies in the orthopedic literature report treatment of these patients with intramedullary rods, both fixed and elongating. The benefits of elongating rods over fixed rods have been demonstrated in regard to reduction in the number of operations performed and facilitation of growth.4,5,12 There are no studies, however, examining the results of bone plating in comparison to the results obtained with elongating intramedullary rods. The purpose of this study was to examine the results of bone plating in patients with osteogenesis imperfecta. Average time to revision following plating was 27 months. This compares quite unfavorably with the five years to revision following placement of Bailey-Dubow rods reported by Luhmann et al.9 It compares more favorably with the average time to revision of 2.5 years following placement of non-elongating rods reported by Marafioti and Westin.10 The most common indication for revision following plating was fracture (6), followed by deformity (3) and hardware failure (3). The complication rate of plating was 69.2%. This rate was slightly higher than the 63.5% complication rate previously reported by Jerosch et al. and significantly higher than the 27% complication rate reported by Marafioti and Westin in their treatment of patients with OI.6,10 Jerosch et al. implanted Bailey-Dubow rods in 107 bones and Kirschner wires in eight bones.6 In their study, the Kirschner wires were implemented because of small bone diameter. The most common complication of Bailey-Dubow rods has been reported to be rod migration.6,7 The most common complication seen after plating was screw pull-out. This seems intuitive given the quality of bone in patients with osteogenesis imperfecta. Not only does the bone quality not allow for purchase of the screws, the bowing of bones may act to further any screw pull-out. Screw pull-out was not a clinical problem in this series unless it was associated with increasing deformity or fracture. The treatment plan for skeletally immature patients with osteogenesis imperfecta must include consideration of growth. The advantage of the elongating rod is that it allows for longitudinal bone growth. The rod does cross the physis, but the diameter of the rod is small enough not to affect growth.2Bone plating does not disturb the physis in most cases, but it does not migrate with growth, thus leaving unsupported bone. Higher revision and failure rates in the bone adjacent to the plate are also most likely due to the sharp disparity in construct rigidity and osteopenic metaphyseal bone.
Considering the higher complication rates, shorter length of time to revision, and unknown effect on longitudinal growth, bone plating does not compare favorably to elongating rods in patients with osteogenesis imperfecta. We recommend elongating rods when considering treatment of deformity or fracture in patients with osteogenesis imperfecta.
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Footnotes
Study conducted at University of Wisconsin Hospital and Clinics, Madison, WI Go to:

References

1. Bailey RW. Studies of longitudinal bone growth resulting in an extensible nail. Surg Forum.1963;14:455 458. [PubMed] 2. Bailey RW. Further clinical experience with the extensible nail. Clin Orthop. 1981;159:171176.[PubMed] 3. Bailey RW, Dubow HI. Evolution of. the concept of an extensible nail accommodating to normal longitudinal bone growth: clinical considerations and implications. Clin Orthop. 1981;159:157170.[PubMed] 4. Gamble JG, Strudwick WJ, Rinsky LA, Bleck EE. Complications of intramedullary rods in osteogenesis imperfecta: Bailey-Dubow rods versus nonelongating rods. J Pediatric Ortho.1988;8(6):645649. 5. Harrison WJ, Rankin KC. Osteogenesis imperfecta in Zimbabwe: a comparison between treatment with intramedullary rods of fixed-length and self-expanding rods. J Royal College Surg Edinburgh.1998;43(5):328 332. 6. Jerosch J, Mazzotti I, Tomasevic M. Complications after treatment of patients with osteogenesis imperfecta with a Bailey-Dubow rod. Archives Ortho & Trauma Surg. 1998;117(4-5):240245. 7. Lang-Stevenson AI, Sharrard WJ. Intramedullary rodding with Bailey-Dubow extensible rods in osteogenesis imperfecta: an interim report of results and complications. J Bone Joint Surg Br. 1984;66-B(2):227 232. [PubMed] 8. Li YH, Chow W, Leong JC. The Sofield-Millar operation in osteogenesis imperfecta: a modified technique. J Bone Joint Surg Br. 2000;82-B(1):1116. [PubMed] 9. Luhmann SJ, Sheridan JJ, Capelli AM, Schoenecker PL. Management of lower extremity deformities in osteogenesis imperfecta with extensible intramedullary rod technique: a 20-year experience. J Pediatric Ortho. 1998;18(1):8894. 10. Marafioti RL, Westin GW. Elongating intramedullary rods in the treatment of osteogenesis imperfecta. J Bone Joint Surg Am. 1977;59A(4):467472. [PubMed] 11. Mulpuri K, Joseph B. Intramedullary rodding in osteogenesis imperfecta. J Pediatric Ortho.2000;20(2):267273. 12. Porat S, Heller E, Seidman DS, Meyer S. Functional results of operation in osteogenesis imperfecta: elongating and nonelongating rods. J Pediatric Ortho. 1991;11(2):200203. 13. Sillence D. Osteogenesis imperfecta: an expanding panorama of variants. Clin Orthop. 1982;159:11 25. [PubMed] 14. Sofield HA, Millar EA. Fragmentation, realignment, and intramedullary rod fixation of deformities of the long bones in children. J Bone Joint Surg. 1959;41A:1371. 15. Stockley I, Bell MJ, Sharrard WJ. The role of expanding intramedullary rods in osteogenesis imperfecta. J Bone Joint Surg Br. 1989;71-B(3):422427. [PubMed] 16. Zionts LE, Ebramzadeh E, Stott NS. Complications in the use of the Bailey-Dubow extensible nail.Clin Orthop. 1998;348:186195. [PubMed]

Management Of Femur Fractures With Self-Made Polymethylmethacrylate Plates, Stainless Steel Plates, Intra-Medullar Pins And Interlocking Nails In Dogs

P. Mukherjee1, D. Ghosh1, S. Roy1 and S. Basu2 West Bengal University of Animal and Fishery Sciences, 37, K. B. Sarani, Kolkata-700 037, India. 1. Department of Veterinary Surgery & Radiology. 2 Department of Veterinary Gynaecology and Obstetrics. Corresponding author Dr. Prasenjit Mukherjee Senior Research Fellow Department of Veterinary Surgery and Radiology West Bengal University of Animal and Fishery Sciences, Kolkata- 700 037, India. SUMMARY

This is a retrospective study of 24 femur diaphyseal transverse fractures stabilized with intra-medullar pinning, steel bone plating, fabricated polymethylmethacrylate (PMMA) plates and intra-medullar interlocking nailing (ILN). Four groups, each including 6 animals, were followed-up for 9 weeks in the perspective of postoperative complications and fracture healing. Routine physical examinations assessed limb function, joint involvement and condition of the operative site. Serum calcium and phosphorus showed no significant change. Full limb function was obtained quicker using fabricated PMMA plates, followed, in the order, by ILN, steel bone plating and intra-medullar pinning. Fabricated PMMA and steel bone plates showed earlier radiographic disappearance of fracture lines and earlier formation of direct bridging callus. The use of fabricated PMMA plates showed promising results for the management of the femur transverse fracture in dogs considering the advantages of lower cost, easy fabrication and actual adaptation to the specific contour of the bone.

Key Words: Bone Plating, Canine, Femur Fracture, Intra-Medullar Interlocking Nailing, Intra-Medullar Pinning, Polymethylmethacrylate Plate.

INTRODUCTION

Among the long bones, the incidence of femur fractures is highest (45.87%) (Gahold et al, 2002) mostly seen in diaphysis and distal metaphysis (Roy et al, 2005). Internal fixation provides mechanical stability to a fractured bone, allowing weight bearing, early use of the limb and rapid healing. The selection of internal fixation is based on mechanical, biologic and clinical parameters associated with each patient and fracture, not just the fracture pattern itself (Aron et al, 1995). Intra-medullar pinning is most widely used because provides axial alignment and resists bending forces but not the shear and rotational forces (Vasseur et al, 1984). Less surgical exposure and dissection is needed to place intra-medullar interlocking nails compared to placement of bone plates. Therefore, the use of intra-medullar interlocking nail may result in preservation of more periosteal vascularity (Heitemeyer et al, 1990), promoting biological osteosynthesis (Reems et al, 2003). Bone plating resists tension, compression, shearing and rotational forces, and depending upon their placement resist bending forces. However, it is a more traumatic procedure (Stiffler, 2004), and demands extreme professional skills to achieve dynamic compression. The present study was carried out to assess the feasibility of using bone plates which contributes to dynamic compression but devoid of some complications like accurate proficiency in contouring plate with bone interface, as well as easy affordability. To this purpose we adopted an extremely versatile thermoplastic polymeric material, polymethylmethacrylate (PMMA), firstly introduced by Charnley (1960), used for decades as

"filler" material in total-hip insertion and recently for internal fracture-fixation plates, to more evenly distribute forces over the plate-bone interface, thereby combating premature plate failure (Moursi et al, 2002).

MATERIAL AND METHODS

Aims To evaluate the efficacy of fabricated polymethylmethacrylate (PMMA) plating as a method of internal fixation in canine diaphyseal femur fractures and to compare it with ILN, intra-medullar pinning and steel plating in view of bone healing and complications. Study design The study was conducted on twenty four (24) clinical cases of femur diaphyseal transverse fractures in dogs between the age group 2-5 years of either sex. The cases were randomly divided in to four groups and treated with four internal fixation devices (Gr. AIntramedullary pinning; Gr. B- Bone Plating; Gr. C- Bone plating with fabricated PMMA plates and Gr. D- Intramedullary Interlocking nailing) comprising six animals in each group. Each animal of different groups were subjected to physical (condition of the operative site, assessment of full limb function, affection of joint as per the method described by Branden and Brinker, 1973) (Table I) and radiological examinations (14 mAs; 50Kvp and 90 cm FFD) throughout the study period. The decision for adopting any one of the internal fixation technique following the standard procedures (DeYoung and Probst, 1985; Conzemius and Swainson, 1999 and Raghunath and Singh, 2002) was randomly adopted. Fabrication of polymethylmethacrylate (PMMA) bone plate For fabrication of PMMA plates of appropriate thickness, two parts polymer of methylmethacrylate powder was mixed with one part of liquid monomer methylmethacrylate . Different sizes of femur from canine cadaver of different body weights were taken as negative cast. Then the PMMA was applied over the lateral side of the femur to achieve 6-8 mm thickness and kept till drying as a cast. The plates then were removed and grounded with sand paper into desired shape and finish and drilled with 3.5 mm drill bit to make six hole plates of different sizes (Fig. 1). Sterilization of fabricated plate was achieved by autoclaving. At the time of surgical intervention, different plates were taken corresponding to the size and body weight similar to patient under the study.

Table: I. Clinical evaluation of functional limb usage Grade Limb use description Nonuse Definition

No functional use of the limb; carries the limb most of the time. Some functional use; will set limb down to stand or walk; carries limb when running; does not bear weight on limb. Functional use of limb; partial weight bearing. Full function for standing, walking, running; full weight bearing.

II

Slight use

III

Limp

IV

Normal

Anaesthesia preoperative preparation and surgical procedure The dogs were pre-anaesthetized with subcutaneous injection of atropine sulphate @ 0.04 mg/kg body weight 15 minutes before the administration of injection xylazine hydrochloride @ 1 mg/kg body weight intramuscularly. After proper sedation, the dogs were placed to the operation table and operation was performed with intraoperative administration of injection ketamine hydrochloride @10 mg/ kg body weight and injection diazepam @ 0.5 mg/ kg body weight intravenously for maintenance of anaesthesia.

Preoperatively, operative site was aseptically prepared with routine application of antiseptic solution, scrubbing and painting. Anesthesia was performed using atropine sulphate (0.04 mg/kg), xylazine hydrochloride (1 mg/kg), ketamine hydrochloride (10 mg/ kg) and diazepam (0.5 mg/ kg). The decision for adopting any one of the internal fixation technique following the standard procedures (DeYoung and Probst, 1985; Conzemius and Swainson, 1999 and Raghunath and Singh, 2002) was randomly adopted. Postoperative care Robert-Jones bandage was applied in all the cases postoperatively for 3 days to alleviate movement and the soft tissue swelling. Animals were intramuscularly administered with injection ceftriaxone @ 10 mg/ kg body weight for 7 days and injection meloxicam @ 0.3 mg/kg body weight for 3 days. Post operative dressing was carried out on 3rd, 5th and 7th day and as and when required. Removal of cutaneous sutures was done after complete healing of the wound in 10th postoperative day. The movements of the animals were restricted over the post operative period for 7-10 days. Implants were kept in situ over the entire study period. Statistical analysis The data were analyzed statistically by general linear model with univariate data by Tukey HSD multiple comparison test (Tukey, 1953) using SPSS 10.0 version for windows.

RESULTS

The anaesthetic regimen provided adequate anaesthesia. None of the animals showed untoward complication due to anesthesia and operative procedures.

Physical examination Postoperative physical examination showed marked soft tissue swelling mostly up to 1st week of operation and in some cases extent of swelling persisted little bit more i.e. up to 2nd week in the animals of all four groups. The postoperative results of limb function viz. range of motion of stifle joint and full functional limb usage have been shown in Table II and III. The clinical evaluation of functional limb usage showed a remarkable difference amongst the study groups being earliest in Gr. C.

Table: II. Results of limb function and Range of Motion of the Stifle Joint (ROMSJ)

1st week Gr. A (n= 6) Grade- I: (n=6)

3rd week Grade- II: (n=6)

5th week Grade- II: (n=4) III: (n=2) Grade- II: (n=1) III: (n=5)

7th week Grade- III: (n=6)

9th week Grade- III: (n=4) IV: (n=2) Grade- II: (n= 1) IV: (n= 5)

ROMSJ A5 week: (n=6)

Gr. B (n= 6)

Grade- I: (n=6) Grade- II: (n=2) III: (n=4)

Grade- II: (n=1) IV: (n=5)

A7 week: (n=1)

Gr. C (n= 6)

Grade- I: (n=5) II: (n=1) Grade- I: (n=6)

Grade- II: (n=1) III: (n= 5) Grade- II: (n=1) III: (n=5)

Grade- III: (n=4) IV: (n=2) Grade- II: (n=1) III: (n=4) IV: (n=1)

Grade- IV: (n=6)

Grade- IV: (n=6)

Gr. D (n= 6)

Grade- II: (n=1) IV: (n=5)

Grade- II: (n= 1) IV: (n= 5)

A7 week: (n=1) A9 week: (n=2

A= ankylosis, N=normal, ROMSJ= range of motion of stifle join

Table: III. Mean S.E. of achievement of Grade IV (full functional) limb usage in days Groups Days Gr. A 63.00 0.00 Gr. B 49.00 0.00 Gr. C 44.33 2.95 Gr. D 46.20 2.80 Radiographic findings Radiographically, fabricated polymethylmethacrylate plated animals showed early disappearance of fracture line and formation of direct bridging callus, whereas in intramedullary pinning, animals exhibited formation of excess external callus and more remodeling time. In intramedullary interlocking nailing, though did not show appreciably noticeable excess external callus formation, they took more remodeling time than steel bone plating and fabricated polymethylmethacrylate plating but lesser than intramedullary pinning. The 9th week post operative diagram of femur fracture of dog managed with intramedullary pin showed no radiographic signs of soft tissue swelling, pin migration or distortion. The radiodensity of the callus at the fracture side was uniform to that of cortical bone, suggesting maturation and remodeling. The medullary cavity was noticed reestablished in proximal and distal fragments of the fracture except at the site of union, which still represented the presence of dense callus packing the medullary canal. The remodeling was yet to be completed though, process found to be in advance stage as evidenced by irregularly arranged hypo dense callus at the periphery of the union site (Figure 2). The end stage radiograph at the 9th week of fracture immobilization in group -B, showed intact radiodense stainless steel plate and screws. The fracture gap was completely obliterated and remodeled imparting uniformity in radiographic features to that of proximal and distal bone fragments. The thickness of cortex at the union site was similar to that of normal in transcortical site (Figure 3). After the 9th week of fracture treatment with PMMA plate the radiograph showed presence of plate and all screws in situ without any materialistic abnormalities. The medullary cavity was established with uniformity of diameter throughout the length of bone. The remodeling was completed which was evidenced by absence of extra callus in the exterior or interior of the cortex at the junctional zone (Figure 4). After 9 weeks of fracture immobilization with ILN in the radiograph, fracture was found completely obliterated with organized callus. The nail and screws were found intact without any distortion, bending or breakage. The medullary canal looked uniform in diameter even at the junctional site to that of proximal and distal fragments (Figure 5).

DISCUSSION

Formation of pre-molded PMMA concave plate was very convenient without much difficulty due to its some inherent biomechanical properties like noncorrosiveness and nonabsorption or degradation of the material within the system (Vcsei and Starlinger, 1982). Marked soft tissue swelling during 1st postoperative week, irrespective of the groups, was due either to the preoperative trauma by the bone fragments and severity of the soft tissue injury during surgery. In group C and B the more duration of perceptible soft tissue swelling was due to more injury inflicted upon the tissue at the time of surgery. Moreover, more number of screw tips which crossed the transcortex might had also resulted more sustained trauma to the muscle mass in comparison to other two groups, where either no screw or less numbers of screws were used. The early ambulation of the affected limbs in the animals treated with PMMA plate in group C, followed by group D (ILN), B (steel plate) and A (intramedullary pinning) were also suggestive of quality of healing in those group in a same order as, weight bearing is considered to be one of the most important gross observable parameter for assessing the quality of fracture healing (Hutzschenreuter et al, 1969). The animals of group A treated with intramedullary pinning showed nonuse of limb for a longer duration (table-II). might have resulted due to the painful swelling of the operated limb which improved in course of time. The more duration of nonuse of the limb by the same animals might be due to incomplete neutralization of the forces as the rotational forces never are neutralized as a result of which slight rotational instability persisted in early phase of fracture healing. Similar to the animals of group A, the femur fracture of dogs immobilized with steel bone plate in group B also showed nonuse of the affected limb during the 1st week of operation which might be due to the inflammatory reaction of tissue at the site. The observation of grade-II and grade-III limb use on 3rd week as well as full functional limb use on 7th week of fracture immobilization indicated the positive correlation of better fracture immobilization and fracture

healing with limb use. The use of bone plate for internal immobilization results to rigid fixation, resisting tension, compression, shearing and rotational forces (Stiffler, 2004). The use of PMMA plate for internal fixation of fracture is comparatively a newer concept with variable success (Kallmes and Jensen, 2003). The postoperative physical finding after using PMMA plates for management of femur fracture in the present study should be graded as promising as, such treated dog showed early ambulation, weight bearing and uneventful recovery which obviously might had resulted from optimum rigid fixation and qualitative fracture healing. Femur fractures were treated with interlocking nail as internal fixation device also showed grade- I limb function in first week which suggested the similar grade of tissue trauma to other groups while the surgical intervention was undertaken for fixing the internal fixation device. Subsequently, the dogs showed better grades of limb ambulation which reached to its best i.e. gradeIV, earliest at 5th to 7th postoperative weeks. Intramedullary pinning in long bone in animals undoubtedly results to better fixation stability barring its incapability for resisting the rotational force which can be overcome by using the ILN (Dueland et al, 1999). The addition of screws or bolts increases the ability of the pin to resist the rotational, shearing and compressive forces at the fracture site. The early and full limb ambulation is one of the criteria on the basis of which apparently quality of callus formation and fracture healing can be assessed, was satisfactorily observed in the animals of the Group D treated with ILN. Intramedullary interlocking nailing does not require perfect anatomic fracture reduction of fracture for stability as such fracture with intramedullary interlocking nail undergoes indirect bone healing as interfragmentary load sharing is not usually obtained (Stiffler, 2004). In the instant study, presence of moderate quantities of external bridging callus in group A and D, is indicative of secondary bone healing with stability of fracture. As compression fixation was not attained by interlocking nailing as well as due to prevention of rotational stability of pin by screwing, the exuberant callus formation was not observed which has also been reported by many workers (Wiss et al, 1986 and Brumback et al, 1988). Radiographically, the fracture fragments were found perfectly aligned, retained without any remarkable anomalies in group B and C. The prefabricated concave plate, when used for immobilization of the bone with convex surface, coupled perfectly covering almost 1/3rd of the circumference, which provided very good gripping when fixed with cortical screws in the present study that might be attributed to the reasons for good alignment , retention of fracture fragments in postoperative observation period. In group B, type of periosteal reaction and formation of callus are in conformity of normal bore healing (Dambacher and Ruegsegger, 1994). At all stages of radiography in both the groups , the minimum external callus formation was observed with quickest symptoms of remodeling. The quality and quantity of fracture callus formation mostly depends on type and accuracy of fracture fixation; more the rigidity and stability in the fixation, minimum is callus formed (Beale, 2004). In the present study, due to rigid fixation, fracture healed by primary union, where direct osteon to osteon union of fragments occured (Stiffler, 2004; Vasseur et al, 1984).

CONCLUSIONS

Based on the above findings it may be concluded that bone plating is considered to be best option than any other immobilization devices but, self fabricated PMMA plate seems promising result in veterinary orthopedic surgery considering its cost, fabrication and facilities for imparting the specific contour of the questioned bone to be repaired, which provide the efficacy of using dynamic compression of fracture healing.

REFERENCES Aron, D.N., Palmer, R.H. and Johnson, A.L., 1995. Biologic strategies and a balanced concept for repair of highly comminuted long bone fractures. Comp. Contin. Educ. Pract. Vet., 17: 35-49. Beale, B., 2004. Orthopedic Clinical Techniques Femur Fracture Repair. Clin. Tech. Small Anim. Pract., 19: 134-150. Branden, T.D. and Brinker, W.D., 1973. Effect of certain internal fixation devices on functional limb usages in dogs. J. Am. Vet. Med. Assoc., 162: 642-646. Brumback, R.J., Uwagie-Ero, S., Lakatos, R.P., Poka, A., Bathon, G.H. and Burgess, A.R., 1988. Intramedullary nailing of femoral shaft fractures. Part II: Fracture-healing with static interlocking fixation. J. Bone Joint Surg. Am., 70 (10):1453-62. Charnley, J., 1960. Anchorage of the femoral head prosthesis to the shaft of the femur. J. Bone Joint Surg., 42: 28. Conzemius, M. and Swainson, S., 1999. Fracture fixation with screws and bone plates. Vet. Clin. North Am. Small Anim. Pract., 29

(5): 1117-1133. DeYoung, D.J. and Probst, C.W., 1985. Methods of fracture fixation. In: Textbook of Small Animal Surgery, W.B. Saunders, Philadelphia, Edn. 1, Slatter, D.H. p 1949-1988. Dueland, R.T., Johnson, K.A., Roe, S.C., Engen, M.H. and Lesser, A.S., 1999. Interlocking nail treatment of diaphyseal long-bone fractures in dogs. J. Am. Vet. Med. Assoc., 214 (1): 59-66. Gahold, B.M., Dhakate, M.S., Patil, S.N., Gawande. P.S. and Kamble, M.V., 2002. Retrospective study of fractures in canines A report of 109 cases. Indian J. Vet. Surg., 23 (2): 129. Heitemeyer, U., Claes, L., Hierholzer, G. and Krber, M., 1990. Significance of postoperative stability of bony reparation of comminuted fractures. Arch. Orthop. Trauma. Surg., 109 (3): 144-149. Hutzschenreuter, R., Perren, S.M., Steinemann, S., Geret, V. and Klebl, M., 1969. Some effects of rigidity of internal fixation on the healing pattern of osteotomies. Injury, 1: 77-81. Kallmes, D.F. and Jensen, M.E., 2003. Percutaneous vertebroplasty. Radiology, 229:2736. Moursi, A.M., Winnard, A.V., Winnard, P.L., Lannutti, J.J. and Seghi, R.R., 2002. Enhanced osteoblast response to a polymethylmethacrylate-hydroxyapatite composite. Biomaterials, 23 (1): 133-144. Raghunath, M. and Singh, S.S., 2002. Intramedullary interlocking nailing (ILN) for long bone fracture fixation in dogs using indigenously designed equipment. Indian J. Vet. Surg., 23 (2): 89-91. Reems, M.R., Beale, B.S. and Hulse, D.A., 2003. Use of a plate-rod construct and principles of biologic osteosynthesis for repair of diaphyseal fractures in dogs and cats: 47 cases (1994-2001). J. Am. Vet. Med. Assoc., 223: 330-335. Roy, S., Samanta, G., Mukherjee, P., Ghosh, D. and De, D., 2005. Occurrence of fracture in dogs in and around Kolkata: A review of 150 cases. In: XXIX Annual Congress of Indian Society for Veterinary Surgery and National Symposium. p 30. Stiffler, K.S., 2004. Internal fixation. Clin. Tech. Small Anim. Pract., 19: 105-113. Tukey, J.W., 1953. The problem of multiple comparisons. Dittoed Manuscript of 396 pages, Department of Statistics, Princeton University. Vasseur, P.B., Paul, H.A. and Crumley, L., 1984. Evaluation of fixation devices for prevention of rotation in transverse fractures of the canine femoral shaft: An in vitro study. Am. J. Vet. Res., 45: 1504-1507. Vcsei, V. and Starlinger, M., 1982. Gentamicin-PMMA bead chains in the treatment of posttraumatic osseous and tissue infections. Arch. Orthop. Trauma Surg., 99 (4): 259-263. Wiss, D.A., Fleming, C.H., Matta, J.M. and Clark, D., 1986. Comminuted and rotationally unstable fractures of the femur treated with an interlocking nail. Clin. Orthop. Rel. Res., 212: 35-47. Copyright Priory Lodge Eduation Limited 2008 First Published November 2008

Trends in the United States in the Treatment of Distal Radial Fractures in the Elderly
Kevin C. Chung, MD, MS,1 Melissa J. Shauver, MPH,1 and John D. Birkmeyer, MD2

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Abstract Background: Traditionally, distal radial fractures in the elderly have been treated nonoperatively with casting. However, since the introduction of the volar locking plating system in 2000, there has been an interest in the use of more aggressive treatment methods. The purpose of the present study was to assess changing trends in the treatment of distal radial fractures in elderly patients in the United States. Methods: We evaluated a 5% sample of Medicare data from 1996 to 1997 and a 20% sample from 1998 to 2005. Information on four treatment methods (closed treatment, percutaneous pin fixation, internal fixation, and external fixation) was extracted from the dataset. Other available data were diagnosis, physician specialty, and patient age, sex, and race. We calculated frequencies and rates to compare the utilization of different treatments over time. Results: Over the ten-year time period examined, the rate of internal fixation of distal radial fractures in the elderly increased fivefold, from 3% in 1996 to 16% in 2005. Closed treatment, however, remained the predominant method (used for 82% of the fractures in 1996 and 70% in 2005). Fractures in patients with an age of eighty-five years or more were significantly more likely to be treated in a closed fashion (p < 0.0001). There was a large variation among physician specialties with regard to the fixation methods that were used. Orthopaedic surgeons were significantly more likely to use closed treatment than hand surgeons were, whereas hand surgeons were significantly more likely to use internal fixation than orthopaedic surgeons were. Conclusions: Since 2000, although the majority of distal radial fractures are still treated nonoperatively, there has been an increase in the use of internal fixation and a concurrent decrease in the rate of closed treatment of distal radial fractures in the elderly in the United States. Distal radial fracture is a public health concern, particularly among the elderly, who often experience fragility fractures. Approximately 10% of sixty-five-year-old white women in the United States will sustain a distal radial fracture during the remainder of their lifetime1. Traditionally, these fractures in the elderly have been treated nonoperatively with use of casting alone2. The use of nonoperative treatment has been based on the perceived low functional demands in the elderly population; however, it has been shown that casting alone for the treatment of unstable osteoporotic distal radial fractures can result in collapse of the fracture fragments and the development of a malunion3,4. Interestingly, despite the development of a malunion, many elderly patients function relatively well, but the majority of studies showing acceptable function involved elderly patients who were frail or had low functional demands5-9. Recently, there has been an interest in more aggressive fracture fixation in the elderly in the hopes of speeding the rate of recovery in order to preserve the ability of patients to live independently2,10-12. The introduction of the volar locking plating system in 2000 has spurred this interest. A recent prospective study evaluating the rate of functional improvement after treatment with the volar locking plating system demonstrated similar rates of recovery between patients in two age groups (twenty to forty years and more than sixty years)13. The volar locking plating system imparts sufficiently stable fixation to maintain good anatomic reduction, even in the elderly14. This stability makes it easier for elderly patients to resume activities of daily living earlier than is the case after treatment with use of the traditional, more conservative approaches that require a longer period of immobilization14.

Despite their high prevalence, the epidemiology of distal radial fractures is not well-characterized and the treatment of these fractures in the elderly population remains ill-defined. The specific purpose of the present investigation was to study a random sample of United States Medicare claims from a ten-year period (1996 to 2005) in order (1) to examine the changing trend in the treatment of distal radial fractures in the Medicare population and (2) to evaluate physician specialty experiences in the treatment of these fractures.
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Materials and Methods For the present study, we used a 5% sample of claims data from 1996 and 1997 and a 20% sample of claims data from 1998 to 2005 from the United States Centers for Medicare and Medicaid Services, obtained by means of a formal request. We obtained this dataset from The Dartmouth Institute for Health Policy and Clinical Practice; investigators at that institution have previously used this particular dataset to track practice variations for a variety of diseases. The dataset has undergone extensive cleaning to allow ease of analysis and is most relevant for studying distal radial fractures. The United States Centers for Medicare and Medicaid Services draws the samples from the claims data for fee-for-service Medicare patients who are sixty-five to ninety-nine years of age. Both samples were of Medicare Part B claims, which cover physicians' services and were randomly selected on the basis of the last two digits of the Health Insurance Claim number15. From this sample, we first extracted claims including an ICD-9-CM (International Classification of Diseases, Ninth Revision, Clinical Modification) code indicating a closed distal radial fracture. Using this smaller group of claims, we then filtered for claims with Current Procedural Terminology codes for closed treatment (with or without manipulation), percutaneous pin fixation, external fixation (uniplane or multiplane), and open treatment (Table I). Because of the coding terminology, we were unable to determine if fixation took place during open treatment. However, it is rare that open treatment is pursued without internal fixation. For these reasons, we will refer to open treatment as internal fixation throughout the present report.

TABLE I

ICD-9-CM and CPT Codes Used for Filtering Medicare Datasets* Each claim contained the Current Procedural Terminology code of the procedure (treatment method) performed, the year in which the claim was filed, the sex of the patient, the age group of the patient (sixty-five to sixty-nine years, seventy to seventy-four years, seventy-five to seventy-nine years, eighty to eighty-four years, and eighty-five years or more), and the racial category of the patient (white or nonwhite). In addition, each claim contained the self-designated primary specialty of the treating physician. The United States Centers for Medicare and Medicaid Services allows the physician to designate as many as three specialties in the order that he or she chooses. For instance, a surgeon may identify himself or herself as an orthopaedic surgeon primarily and as a hand surgeon secondarily. Alternatively, the same surgeon could identify himself or herself as a hand surgeon primarily and as an orthopaedic surgeon secondarily. The dataset that we obtained contained only the primary specialty designation. It is quite possible that an orthopaedic hand surgeon may identify himself or herself as an orthopaedic surgeon primarily and as a hand surgeon secondarily. Frequencies were calculated for 1996 to 1997 by multiplying the 5% sample by 20. Likewise, frequencies for 1998 to 2005 were calculated by multiplying the 20% sample by 5. This is a standard and often-used method to

determine overall frequencies from small samples16-18. The significance of differences between groups was analyzed with use of the Student t test and odds ratios.
Source of Funding

The present study was supported in part by a grant from the American Foundation for Surgery of the Hand, the National Institute of Arthritis and Musculoskeletal and Skin Diseases Exploratory/Developmental Research Grant Award (R21 AG030526), a Clinical Trial Planning Grant (R34 AR055992-01), and a Midcareer Investigator Award in Patient-Oriented Research (K24AR053120) to one of the authors (K.C.C.). Funds were used to purchase the dataset and for salary support.
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Results The 5% dataset (1996 to 1997) and the 20% dataset (1998 to 2005) represented an average of 81,008 Medicare claims (range, 76,080 to 87,315 claims) for distal radial fracture treatment per year. The tabulation of this tenyear dataset is presented in Table II. Closed treatment was the predominant method of distal radial fracture fixation in these patients (Fig. 1). In 2005, 70% of the Medicare claims were for closed treatment. The rate of percutaneous pin fixation, the second-most-frequently used method of treatment, remained flat before decreasing slightly between 2004 and 2005. The rate of external fixation use was very low, with little change occurring over the study period. There was an increasing trend in the use of internal fixation (from 3% to 16%), which corresponded with a decrease in the use of closed treatment (from 82% to 70%).

TABLE II

Estimated Frequency and Percentage of Fractures Treated Each Year According to Physician Specialty*

Fig. 1

Line graph illustrating the rate of each fixation method according to year. There was very little variation in fixation method according to sex. Male patients were 1% more likely to be managed with closed reduction, and female patients were 2% more likely to be managed with percutaneous pinning. There was no difference between the sexes with regard to the use of internal or external fixation. There was also no notable difference in the utilization of fixation techniques according to racial group. White patients were 1% more likely to be managed with percutaneous pinning, whereas nonwhite patients were 1% more likely to be managed with both closed reduction and internal fixation. As with sex, there were no racial differences in terms of the percentage of patients who received external fixation. As patients aged, the rate of nonoperative treatment increased (Table III). Overall, the rate of closed reduction increased from 70.9% of all patients who were sixty-five to sixty-nine years of age to 87.0% in patients who were more than eighty-five years of age (p <

0.0001). Likewise, the rate of internal fixation decreased from 10.9% in the youngest age group to 1.0% in the oldest age group.

TABLE III

Estimated Frequency* and Percentage of Fractures by Age Groupand Fixation Method There was a considerable difference among physician specialties with regard to the fixation methods used (Fig. 2). Orthopaedic surgeons were significantly more likely to use closed reduction than hand surgeons were; specifically, closed reduction was used for 78.2% of fractures treated by orthopaedic surgeons, compared with 56.5% of fractures treated by hand surgeons (p < 0.0001). Similarly, hand surgeons were significantly more likely to use internal fixation than orthopaedic surgeons were; specifically, internal fixation was used for 27.1% of fractures treated by hand surgeons, compared with 6.3% of fractures treated by orthopaedic surgeons (p < 0.0001). The odds of performing closed treatment as opposed to internal fixation were 5.7 times greater for an orthopaedic surgeon as compared with a hand surgeon (95% confidence interval, 5.3 to 6.1; p < 0.0001). There was no difference between the specialties with regard to the rate of use of percutaneous pinning, and both specialties seldom used external fixation.

Fig. 2

Bar graph illustrating the use of each fixation method according to primary self-designated physician specialty. Ten percent of distal radial fractures were treated by nonsurgeons (Fig. 2); this finding was unexpected. Most commonly, these individuals were physicians with the primary designation of emergency medicine and family practice. However, the treatment provided by these individuals was limited almost exclusively to closed reduction. It is probable that physicians in these two specialties are treating distal radial fractures in the emergency department or in outpatient clinics in the acute setting.
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Discussion Changing trends in the treatment of distal radial fractures in elderly patients in the United States are evident in this ten-year review of Medicare data. It is well known that closed reduction may not adequately restore anatomic alignment11,12; at least 50% of the fractures that are treated in this manner lead to malunion 3,4. Furthermore, closed reduction requires four to six weeks of wrist immobilization, which can lead to stiffness. Disuse of the hand and wrist can result in osteopenia that may result in fracture collapse7. However, through 2005, closed reduction remained the predominant method of treatment of distal radial fractures in the elderly in the United States. The present study also demonstrates that despite the common use of closed treatment, distal radial fractures in the Medicare population are increasingly treated with internal fixation methods. Because of the general nature of the Current Procedural Terminology coding, we are unable to ascertain exactly which internal fixation technique was used. However, the rapid increase in the use of internal fixation corresponded with the earliest report on the volar locking plating system, which was published in 200019.

Before the introduction of the volar locking plating system, internal fixation was accomplished with a variety of methods, including dorsal plating, which today is viewed less favorably because of complications related to implant loosening, tendon rupture, and wrist stiffness20-24. These results are corroborated by an examination of American Board of Orthopaedic Surgery Part II oral examination data from 1999 to 2007. Koval et al. found that internal fixation of distal radial fractures increased dramatically over this eight-year period, and they postulated that this increase may have been due to the introduction of the volar locking plating system25,26. With internal fixation, elderly patients require less immobilization time and may be able to return to normal activities sooner. However, one study that compared two weeks of wrist immobilization with six weeks of immobilization following fixation with the volar locking plating system demonstrated no significant difference between the two groups with regard to the final range of wrist motion27. Internal fixation techniques require more operative dissection and may be technically challenging. The invasiveness of the operation also may be associated with more complications. Nevertheless, a randomized controlled trial by Leung et al.24 demonstrated that patients managed with plate fixation had significantly better outcomes than patients managed with external fixation and pin fixation. Furthermore, three retrospective studies supported the use of internal fixation for the treatment of distal radial fractures in the elderly; two studies supported its use in general2,12, and one supported the use of the volar locking plating system specifically11. The present study confirms the increasing popularity of this fixation method. However, because our data provided no information on outcomes, the popularity of this mode of treatment does not necessarily indicate its superiority. The present study revealed that most physicians with the primary designation of orthopaedic surgeon still predominantly employed closed methods for the treatment of distal radial fractures. Conversely, physicians with the primary designation of hand surgeon were much more inclined to apply internal fixation methods. This finding was observed in the study by Koval et al. as well, in which hand-fellowship-trained surgeons employed open treatment 84% of the time, whereas those without hand-fellowship training used open treatment only 57% of the time25. The present study has several limitations. The most obvious limitations are the generality of coding for internal fixation and the imprecision of coding for the medical specialty of the treating physician. A single code for all internal fixation techniques cannot discern the type of fixation procedures used. It would be interesting to know if the rapid increase in internal fixation from 2002 to 2005 mainly comprised fixation with the volar locking plating system. The dataset that we obtained included only the primary identifier for specialty, although physicians are allowed to designate both a primary and a secondary specialty. This means that the accuracy of the specialty designations was very dependent on how the providing physician entered the data. Physicians who identified themselves as orthopaedic surgeons primarily and hand surgeons secondarily would be coded as orthopaedic surgeons in this dataset, whereas physicians who reported hand surgery first and orthopaedic surgery second would be coded as hand surgeons. It is possible that some hand surgeons identified themselves as orthopaedic surgeons primarily and that the information that their practices are predominantly composed of hand surgery was not available to us. However, the large difference in the rate of utilization of the surgical procedures between the self-designated orthopaedic surgeons and the self-designated hand surgeons cannot be accounted for by the specialty coding issue alone. Finally, because there were no patient identifiers in our dataset, some patients may have been counted more than once. This may have occurred if a patient received closed treatment in an emergency department and was later referred for surgical intervention. We believe that although this is possible, it is not especially likely. As noted, emergency medicine physicians accounted for only 6% of the closed treatment cases. The Dartmouth Atlas of Musculoskeletal Health Care explored geographic variations in the incidence and surgical treatment of various musculoskeletal injuries (including distal radial fractures) in the United States by examining the Medicare database from 1996 to 199728. The investigators reported evidence of marked geographic variations and found that surgical intervention rates varied as much as tenfold. However, the investigators did not examine the change in rates over time. We examined changes in the treatment of distal

radial fractures in the elderly population in the United States over time. The elderly population is growing at an ever-increasing rate29, and elderly individuals are now more active than ever30. They often prefer medical treatments that do not hamper their activities. These factors all point to a shift toward the increased use of more aggressive treatments of distal radial fractures in elderly patients, including internal fixation, which had previously been reserved for younger patients.
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Notes Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from the American Foundation for Surgery of the Hand, the National Institute of Arthritis and Musculoskeletal and Skin Diseases Exploratory/Developmental Research Grant Award (R21 AG030526), a Clinical Trial Planning Grant (R34 AR055992-01), and a Midcareer Investigator Award in Patient-Oriented Research (K24 AR053120). Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.
Investigation performed at the University of Michigan, Ann Arbor, Michigan
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References 1. Cummings SR, Black DM, Rubin SM. Lifetime risks of hip, Colles', or vertebral fracture and coronary heart disease among white postmenopausal women. Arch Intern Med. 1989;149:2445-8. [PubMed]
2. Beharrie AW, Beredjiklian PK, Bozentka DJ. Functional outcomes after open reduction and internal fixation for treatment of displaced distal radius fractures in patients over 60 years of age. J Orthop Trauma. 2004;18:680-6. [PubMed] 3. Mackenney PJ, McQueen MM, Elton R. Prediction of instability in distal radial fractures. J Bone Joint Surg Am. 2006;88:1944-51. [PubMed] 4. Strange-Vognsen HH. Intraarticular fractures of the distal end of the radius in young adults. A 16 (2-26) year follow-up of 42 patients. Acta Orthop Scand. 1991;62:527-30. [PubMed] 5. Grewal R, MacDermid JC. The risk of adverse outcomes in extra-articular distal radius fractures is increased with malalignment in patients of all ages but mitigated in older patients. J Hand Surg [Am].2007;32:962-70. 6. Young BT, Rayan GM. Outcome following nonoperative treatment of displaced distal radius fractures in lowdemand patients older than 60 years. J Hand Surg [Am]. 2000;25:19-28. 7. Beumer A, McQueen MM. Fractures of the distal radius in low-demand elderly patients: closed reduction of no value in 53 of 60 wrists. Acta Orthop Scand. 2003;74:98-100. [PubMed] 8. Anzarut A, Johnson JA, Rowe BH, Lambert RGW, Blitz S, Majumdar SR. Radiologic and patient-reported functional outcomes in an elderly cohort with conservatively treated fractures. J Hand Surg [Am]. 2004;29:1121-7.

9. Hegeman JH, Oskam J, Vierhout PAM, ten Duis HJ. External fixation for unstable intra-articular distal radial fractures in women older than 55 years. Acceptable functional end results in the majority of the patients despite significant secondary displacement. Injury. 2005;36:339-44. [PubMed] 10. Orbay JL, Fernandez DL. Volar fixation for dorsally displaced fractures of the distal radius: a preliminary report. J Hand Surg [Am]. 2002;27:205-15. 11. Orbay JL, Fernandez DL. Volar fixed-angle plate fixation for unstable distal radius fractures in the elderly patient. J Hand Surg [Am]. 2004;29:96-102. 12. Jupiter JB, Ring D, Weitzel PP. Surgical treatment of redisplaced fractures of the distal radius in patients older than 60 years. J Hand Surg [Am]. 2002;27:714-23. 13. Chung KC, Squitieri L, Kim HM. Comparative outcomes study using the volar locking plating system for distal radius fractures in both young adults and adults older than 60 years. J Hand Surg [Am].2008;33:809-19. 14. Ring D, Jupiter JB. Treatment of osteoporotic distal radius fractures. Osteoporos Int. 2005;16 Suppl 2:S804. [PubMed] 15. Department of Health and Human Services. Centers for Medicare and Medicaid Services. Standard analytical files. http://www.cms.hhs.gov/IdentifiableDataFiles/02_StandardAnalyticalFiles.asp. Accessed 2008 Nov 3. 16. University of Minnesota. Research Data Assistance Center.http://www.resdac.umn.edu/CCW/CCWFAQ.asp. Accessed 2008 Nov 7. 17. Murphy TP, Soares G, Kim M. Increase in utilization of percutaneous renal artery interventions by Medicare beneficiaries, 1996-2000. AJR Am J Roentgenol. 2004;183:561-8. [PubMed] 18. McBean M, Rajamani S. Increasing rates of hospitalization due to septicemia in the US elderly population, 1986-1997. J Infect Dis. 2001;183:596-603. [PubMed] 19. Orbay JL. The treatment of unstable distal radius fractures with volar fixation. Hand Surg.2000;5:10312. [PubMed] 20. Kreder HJ, Hanel DP, Agel J, McKee M, Schemitsch EH, Trumble TE, Stephen D. Indirect reduction and percutaneous fixation versus open reduction and internal fixation for displaced intra-articular fractures of the distal radius: a randomised, controlled trial. J Bone Joint Surg Br. 2005;87:829-36.[PubMed] 21. Grewal R, Perey B, Wilmink M, Stothers K. A randomized prospective study on the treatment of intraarticular distal radius fractures: open reduction and internal fixation with dorsal plating verses mini open reduction, percutaneous fixation, and external fixation. J Hand Surg [Am]. 2005;30:764-72. 22. Westphal T, Piatek S, Schubert S, Winckler S. Outcome after surgery of distal radius fractures: no differences between external fixation and ORIF. Arch Orthop Trauma Surg. 2005;125:507-14.[PubMed] 23. Kambouroglou GK, Axelrod TS. Complications of the AO/ASIF titanium distal radius plate system (pi plate) in internal fixation of the distal radius: a brief report. J Hand Surg [Am]. 1998;23:737-41. 24. Leung F, Tu YK, Chew WY, Chow SP. Comparison of external and percutaneous pin fixation with plate fixation for intra-articular distal radial fractures. A randomized study. J Bone Joint Surg Am.2008;90:1622. [PubMed]

25. Koval KJ, Harrast JJ, Anglen JO, Weinstein JN. Fractures of the distal part of the radius. The evolution of practice over time. Where's the evidence? J Bone Joint Surg Am. 2008;90:1855-61.[PubMed] 26. Drobetz H, Kutscha-Lissberg E. Osteosynthesis of distal radius fractures with a volar locking screw plate system. Int Orthop. 2003;27:1-6. [PubMed] 27. Lozano-Calderon SA, Souer S, Mudgal C, Jupiter JB, Ring D. Wrist mobilization following volar plate fixation of fractures of the distal part of the radius. J Bone Joint Surg Am. 2008;90:1297-1304.[PubMed] 28. Weinstein JN, Birkmeyer JD. The Dartmouth atlas of musculoskeletal health care. Chicago, IL: American Hospital Association; 2000. 29. US Census Bureau. National population estimatescharacteristics. National sex and age. April 1, 2000, to July 1, 2006. http://www.census.gov/popest/national/asrh/NC-EST2006-sa.html. Accessed 2008 July 17. 30. Manton KG, Gu X, Lamb VL. Change in chronic disability from 1982. to 2004/2005 as measured by longterm changes in function and health in the U.S. elderly population. Proc Natl Acad Sci U S A.2006;103:18374-9.

Open reduction and internal fixation of clavicular nonunions with allograft bone substitute
Michael D. Riggenbach, Grant L. Jones, and Julie Y. Bishop

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Abstract
Background:

Biologic augmentation with allograft has shown equivalent healing rates to autograft in several nonunion models. No literature exists clearly demonstrating this in the clavicle. The purpose of this study was to evaluate the healing and complication rates of clavicle nonunions treated solely with open reduction and internal fixation (ORIF) and allograft.
Materials and Methods:

Nineteen clavicle nonunions treated with ORIF and allograft were evaluated retrospectively to assess healing rates and complications based on clinical symptoms and radiographic findings.
Results:

For the 19 patients included and treated with ORIF and allograft, clinical follow-up averaged 15 months. Seven patients were smokers. Although complete radiographic healing was achieved in only 68% of patients, clinical success occurred in 16 (84%) patients who demonstrated full range of motion and strength without pain. The three patients who did not demonstrate full radiographic healing were completely pain free. Five patients experienced complications (26%). Two underwent hardware removal due to persistent irritation after union. Three had a persistent painful nonunion. Each of these three patients was a smoker (P=0.08). Two proceeded to union after revision fixation. The other had hardware failure, which was removed, with a persistent nonunion and did not wish any further treatment.
Conclusion:

ORIF with allograft bone substitute is an acceptable treatment alternative to iliac crest bone graft for clavicle nonunions. However, we did not demonstrate equivalent healing rates to published results utilizing autograft. Smokers were identified to have a trend toward higher failure rates with ORIF augmented with allograft and therefore these patients may be better served by augmenting fixation with autograft.
Level of Evidence:

IV; retrospective comparative study. Keywords: Allograft bone substitute, clavicle nonunion, iliac crest bone graft, open reduction and internal fixation
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INTRODUCTION

Clavicle fractures account for up to 10% of all fractures and are typically sustained by young, active males.[13] Most nondisplaced, minimally comminuted shaft fractures are treated nonoperatively and heal without complication. Most stable lateral clavicle fractures heal without event as well, although unstable distal clavicle fractures have a higher nonunion rate of up to 30%.[4] Overall, the nonunion rate after nonoperative treatment of clavicle fractures is rare, reportedly ranging from less than 1 to 4.5%.[5,6] However, female gender, age, fracture displacement, fracture stability, and comminution have been shown to increase this nonunion risk in some studies to between 33 and 47%.[5,7] Patients may present with mechanical symptoms, intractable pain, motion restriction, and even thoracic outlet syndrome.[8,9] These persistent symptoms may limit functional capacity and often necessitate surgical intervention. Open reduction and internal fixation (ORIF) with autologous iliac crest bone graft (ICBG) has been the gold standard to address clavicular shaft nonunions. A review of the literature demonstrates healing rates ranging from 89 to 100%.[14,8,10,11] Although ICBG is very effective for fracture healing, complications from graft harvest can potentially cause significant morbidity. Major complications such as pelvic fracture, infection, prolonged pain, and minor complications such as persistent drainage, sensory disturbances, and temporary pain range from 0.7 to 25% and 9.4 to 24%, respectively.[1219] Hip pain has been shown to persist as long as six months postoperatively in 37.9% of patients.[13,14] Even with meticulous technique, the potential for graftsite complications and their associated morbidity remains and continues to be a substantial concern for the treating surgeon. In an effort to minimize graft-site complications, alternative methods to augment healing have emerged. ORIF with demineralized bone matrix (DBM) rather than ICBG has shown equal efficacy in treating nonunions of the humerus and tibia,[18,19] and variable enhancement of fusion rates in the spine without the associated morbidity of graft harvest.[20] However, the literature incorporating graft alternatives in clavicle nonunions is sparse. Endrizzi et al. performed a retrospective analysis of superior plate fixation in the treatment of clavicular nonunions citing a 93% healing rate.[21] However, only 29.8% of these patients were treated with DBM and the other 63.8% were treated with local autogenous graftthus, the study was not just evaluating the use of allograft alternatives. In addition, they did not differentiate healing rates in those with DBM vs those with autogenous graft. Thus, no series exists demonstrating the efficacy of ORIF with allograft bone substitute alone when treating clavicular nonunion. The purpose of this investigation was to evaluate the clinical outcomes, radiographic healing, and complication rate of clavicle nonunions treated with ORIF and allograft bone substitute.
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MATERIALS AND METHODS


Institutional Review Board Approval was obtained prior to investigation. The records of two shoulder surgeons at a tertiary referral center over the previous five years (2004-2009) were retrospectively reviewed to identify all clavicle nonunions requiring operative intervention. Inclusion criteria consisted of any patient between the ages of 18 to 89 years with a symptomatic clavicular nonunion. A nonunion diagnosis was based on radiographic [Figures [Figures11 and and2]2] as well as clinical exam findings consistent with a symptomatic nonunion (continued pain, mechanical symptoms, tenderness, and/or crepitus on exam). These patients presented for operative fixation due to their persistent symptoms and failure of conservative management. Based on these criteria, 24 patients with a clavicular nonunion were identified. Five patients were excluded, two due to segmental defects requiring iliac crest corticocancellous graft, one due to incarceration, one due to suture fixation of a distal clavicle fracture, and one due to death unrelated to the surgery, two months postoperatively, preventing postoperative evaluation.

Figure 1

Clavicle nonunion (a). Union demonstrated after fixation (b); patient had radiographic and clinical evidence of union after fixation

Figure 2

Clavicle nonunion (a). No radiographic evidence of complete union (b) despite full strength, range of motion and no pain on clinical exam. Fracture line still visible eight months postoperatively (arrow) We recorded information about the subject's age, clavicular nonunion location, type, duration, range of motion, strength, tobacco use, length of postoperative follow-up, clinical and radiographic evidence of healing, and any complications.
Surgical technique

Patients were given a preoperative interscalene block and administered general anesthesia. They were placed supine on the operating table with a scapular bump. An oblique incision was made in line with the clavicle over the nonunion site. The nonunion site was identified, debrided of fibrous tissue and/or attempted callus to expose bleeding bone edges. The debrided nonunion site was then reduced and fixed on the superior surface of the clavicle with a precontoured locking clavicle plate. All plate fixation constructs achieved a minimum of three screws medial and lateral to the nonunion site. One of the following healing adjuncts was placed at the nonunion site: 12 received platelet-rich plasma (PRP) with DBM and the other seven received allograft corticocancellous chips. In one case, the allograft chip was supplemented with rhBMP-2, and in a second case, another with calcium phosphate cement. The deltotrapezial fascia, subdermal and dermal layers were closed in succession. The deltotrapezial fascia, subdermal and dermal layers were closed in succession.
Postoperative care

Patients were discharged home the same day of surgery with a sling for the first six weeks. Patients then progressed to active shoulder range of motion over the next six weeks as their symptoms allowed. At each postoperative visit, the investigators examined patients for tenderness to palpation over the nonunion site, active and passive range of motion, and strength at the shoulder. Radiographs were taken at the six-week and three-, six-, and 12-month visits and evaluated for bridging callus in two views. Strengthening was allowed when the patients had no clinical signs of pain. Patients were allowed to return to full activity when they had radiographic evidence of healing, no clinical tenderness, and return of full pain-free strength, comparable with the contralateral side.
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RESULTS The 19 patients included in this study were treated with ORIF and allograft bone substitute. Patients averaged 41.1 years in age (range, 18-57 years). A mean of 19 months elapsed between initial injury and presentation (range, 2.5-120 months). Seven patients (37%) were smokers. Eleven patients (58%) had an atrophic nonunion on preoperative X-rays. Five had a hypertrophic nonunion, and the remaining three had an oligotrophic nonunion. Eighteen patients demonstrated midshaft nonunion and one had a medial shaft nonunion. All 19 patients underwent plate fixation. Average follow-up was 15 months (range, 2.5-48 months). Patient 11 was only followed up for 2.5 months after their surgery due to clinical and radiographic evidence of healing and demonstration of full function at that time. Overall, initial radiographic evidence of healing was obtained in 13/19 (68%) patients[Figure 1b]. One patient could not afford final radiographs but had eight months of clinical follow-up and is clinically healed. Two patients without radiographic evidence of healing exhibited clinical signs of union by examination[Figure 2b]. They did not have any hardware complications, had no further interventions, and returned to full function. The other three patients are discussed below in the complication section. A total of 16 patients exhibited clinical signs of healing (84%). These patients had no pain, achieved full strength in resisted forward elevation and external rotation, and achieved range of motion equal to the contralateral side and were satisfied with their result.
Complications

There were five total complications (26%). Two were minor (hardware removal due to persistent irritation). Three major complications occurred. One of these occurred in a patient with hypertrophic nonunions, while the other two were in patients with atrophic nonunions. Three patients had failures requiring revision fixation, and two of these were catastrophic failures. Patient 19 had the plate catastrophically fail, requiring revision fixation with ICBG. He subsequently developed a hematoma requiring irrigation and debridement. This patient eventually healed without any further complications. Patient 15 had a persistent nonunion with painful instability at the nonunion site. He underwent revision fixation with DBM, which healed without any further issues. Patient 10 had four total surgeries, including revision ORIF after the initial plate fixation pulled out. He then underwent two subsequent irrigation and debridement procedures for persistent hematoma and then removal of hardware after a stress fracture developed medial to his plate. This patient's nonunion persisted, and he did not wish any further attempts at fixation. Overall, 2 of the 3 persistent nonunions did go on to eventual union, bringing the final radiographic union rate up to 80% and final clinical healing rate up to 95%. Each of the three patients with a persistent nonunion were smokers (average 0.8 pks/day) and continued to smoke during treatment despite advice to the contrary. This rate of persistent nonunion in smokers approached statistical significance (P=0.08) compared with those who went on to clinical union. The two patients with clinical evidence of healing, but not radiographic evidence of healing, were not smokers. There was no difference in complication rate in those with allograft corticocancellous chips vsthose with PRP and DBM. Table 1 lists data regarding each patient and his/her respective outcome.

Table 1

Patient demographics
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DISCUSSION Despite the success of ORIF with ICBG in treating clavicular nonunions, extensive literature exist exploring alternative fixation constructs and biologic adjuncts in an attempt to minimize potential graft-site morbidity. In their study evaluating external fixation of clavicle fractures and nonunions, Schiund et al. healed all five nonunions treated with a Hoffmann external fixator with no re-fractures.[22] Boehmeet al. achieved 95% healing rates with Hagie pin fixation, corticoperiosteal first rib, and ICBG.[23] They cited incisional cosmesis with Langer's lines, load sharing with intramedullary fixation, and ease of hardware removal as benefits to intramedullary fixation. However, unlike a plate and screw construct, the pin does not provide rotational control. This led the authors to restrict forward elevation above 90 degrees in the early stages of rehabilitation. There was a significant rate of hardware irritation as pin removal occurred in 17 patients (81%) due to a painful bursa forming at the lateral end of the clavicle; two pins broke during removal. Despite this, they reported no graft-site complications, although most surgeons do not have a comfort level with obtaining corticoperiosteal first rib grafts. However, the complication rate with the use of the Hagie pin has ranged 25.8 to 50% and to some degree, has limited their overall use.[24,25] Fifty-three to 66% of these complications are from skin irritation or persistent pain; yet, the nonunion rate when using this construct in the acute setting is only 8.6%.[24,25] In examining graft choices, ICBG remains the gold standard, and the morbidity associated with obtaining it has been well studied. Complication rates for harvesting ICBG vary significantly in the literature, based on procedure, graft site, and designation of major and minor complications. Ahlmannet al. reported major complications (hernia, pain >6 months) to be 8% and 2% for anterior and posterior ICBG, respectively.[17] The minor complication rate (superficial hematomas, temporary pain/sensory disturbances) was 15% and 0% for anterior and posterior grafting, respectively.[17] Similarly, Younger and Chapman reported major and minor complication rates of 5.3 and 25%, respectively, for anterior ICBG sites and 11.3 and 18.4%, respectively, for posterior grafting sites.[26] Subsequently, Ahlmann et al. recommended posterior grafting whenever possible.[17] However, when positioning a patient for fixation of a clavicle nonunion, this step would add significant time and complexity to the operation. Because of this complication rate, alternative graft sources are becoming more frequently studied to determine if healing rates are acceptable given the decreased morbidity. Tashjian and Horwitz infused tricalcium phosphate with iliac crest aspirate during open reduction and plate fixation in ten clavicle nonunions and reported a 90% healing rate with no graft-site complications.[27] Their only failure was due to a postoperative wound infection and subsequent persistent nonunion. Vascularized corticoperiosteal bone grafts from the medial femoral condyle and vascularized fibula strut grafts demonstrate excellent healing capabilities, with 100% healing rates.[28,29] The authors caution that these vascularized grafts should be used for refractory nonunions or in adverse healing environments such as an irradiated tissue bed. Therefore, they are an unlikely source of graft for the first-time treatment of a clavicle nonunion. Like the vascularized bone grafts, DBM has shown success with bone healing in other clinical trials. DBM is created from allograft bone demineralized with acid extraction, leaving collagen and non-collagenous proteins, including growth factors. The osteoinductive potential of the graft is influenced by a number of factors: The sterilization process, the carrier, the total amount and ratios of bone morphogenetic protein (BMP) present.[3032] Hierholzer et al. compared DBM with ICBG in their series of humeral nonunions treated with plate fixation.[19] Augmentation with DBM yielded a 97% healing rate with no donor site morbidity, while 44% of patients augmented with autologous ICBG had donor-site morbidity.[19] Similarly, Gardner et al. healed 30/31 (97%) distal femoral nonunions in which 30% were treated with DBM.[33] In a multicenter randomized controlled trial of tibial nonunions treated with intramedullary (IM) nailing and either autologous ICBG or OP1 (BMP-7) implanted in a bovine collagen carrier (DBM), DBM demonstrated statistically equivalent clinical and radiographic healing rates at nine months and two years (81% vs 85%).[18] When treating 47 clavicular nonunions, Endrizzi et al. utilized DBM alone in 29.8% of patients, drill reamings in 63.8%, and ICBG in 6.4% to yield a 93% rate of union.[21] Despite their usage of DBM in nearly a third of their patients, their reoperation rate only approximated 7%. However, they did not differentiate between

healing rates for those with DBM vs local grafting. Still, one must exercise caution in choosing an allograft substitute. Variation in each company's bone supply and mode of preparation yields varying qualities of DBM. For instance, Peterson et al. found that Grafton putty yielded the most fusion material at eight weeks in athymic rats when comparing three brands of DBM.[34] Allograft bone substitute has also been studied in combination with autograft with similar success. Morone and Boden demonstrated that decreased autograft volume could be supplemented with DBM gel to yield fusion rates similar to those following use of autograft alone.[35] Overall, as many different allograft sources are available, at this point, the best source is yet to be determined. Multiple factors influence the surgeons choice and cannot be explored in depth in this paper. Our study demonstrated an 84% clinical healing rate with an overall complication rate of 26%. Although the authors recognize that the clinical success rate was 84%, the three individuals without radiographic evidence of healing cannot be considered truly healed as the goal of using biologic enhancement is to obtain bony healing. Radiographic healing is truly the best indicator of success of the use of allograft. Thus, our radiographic healing rate of 68% is certainly not equivalent to the reported healing rates in the literature for autograft, which range from 89 to 100%. Although the complication rate is slightly higher than those in the studies using ORIF with ICBG, those reported rates mostly focused on graft-site morbiditynot the complications regarding the surgical procedure itself.[3] Two of our complications were minor and involved painful hardware that was removed. However, three of the complications were persistent nonunions, two of which failed catastrophically. Thirtyseven percent of the patients in this study were smokers and in particular, the three patients with persistent nonunions each smoked at least one pack of cigarettes daily. Although it did not reach statistical significance (P=0.08), the numbers do suggest that a trend may be present and perhaps a smoking history should be the reason for pause when using allograft bone substitute. This trend is supported by Ziran et al. who noted healing rates of 67.9% and 87.5% in smokers and nonsmokers receiving allograft for fractures and nonunions, respectively.[36] Likewise, Endrizzi et al. noted that their only reoperations were on smoking patients (N=3).[21] We believe that those with segmental bony defects should receive ICBG. We did exclude these patients from our study and did not review their charts further (The incorporation of an autogenous graft with structural integrity in this instance theoretically appears superior and is supported in the literature). Ballmer et al. had 100% union rate at six months in patients receiving tricortical ICBG for segmental clavicular defects greater than or equal to 15 mm.[9] Additionally, Endrizzi et al. also refrained from DBM in segmental defects, however, they did not specify what size of defect would lead them to ICBG.[21] Two issues arose when examining the graft sources chosen to augment plate fixation in this study. Although DBM was the primary graft source (68%), allograft corticocancellous bone chips (37%) supplemented with rhBMP (5%) and calcium phosphate (5%) were also included. This study's intention was not to isolate a particular substance to prove similar efficacy to ICBG. Rather, it was to present a series of patients supplemented with a nonautogenous graft source rather than ICBG and demonstrate its efficacy at healing clavicle nonunions. Admittedly, this is a limitation of the study. However, this is not a commonly seen operative problem, and the graft sources of the treating surgeons did change throughout the years of retrospective data collection. Ideally, we would have used identical graft choices in each patient. In addition to the heterogeneity in graft choice, we incorporated PRP at the nonunion site in 12 (63%) of patients to augment healing. It is unknown whether this helped stimulate healing. Previous studies showed mixed results with its efficacy in stimulating bone formation. Sanchez et al. reported healing of all femoral nonunions (N=15) with injection of PRP in conjunction with allograft, despite two requiring repeated percutaneous injections.[37] Likewise, Han et al. found significant increases in DBM osteoinductivity with PRP when not activated by thrombin.[38] However, another study by Mariconda et al. demonstrated no improvements in union rates or time to union when PRP was injected into atrophic tibial, humeral, or forearm nonunions.[39] Markou et al. showed no difference in bone formation for periodontal bone defects treated with either PRP or PRP and allograft.[40] We cannot draw any conclusions on PRP based on our study. However, our results demonstrate that allograft bone substitute, in a variety of forms, has the potential to facilitate healing in a clavicular nonunion, in particular, in a non-smoker.

Although this study is the first to look only at clavicular nonunions treated with ORIF and bone graft substitute, it does have several limitations. It is a retrospective case series without randomization to a treatment group, and as stated above, has a lack of standardization to treatment when utilizing allograft source choices. Eighteen of the fractures were fixed with a locking clavicle plate; however, one was treated with a pelvic recon plate. A cleaner study would employ the same type of fixation for all fractures. One fracture was more medial and is susceptible to different forces across the fracture site and thus perhaps a different union potential, but it was rigidly fixed with a locking plate. However, our goal was to look at all clavicle nonunions to evaluate the efficacy of allograft as an alternative and successful treatment option when compared with ICBG. We believe our data do demonstrate acceptable healing rates without graft-site morbidity. However, we do recognize that our healing rates are inferior to the reported healing rates for the use of allograft. Lastly, follow-up was not optimally standardized with functional assessments or complete radiographic profiles to ensure healing as several patients ceased to follow-up once they had obtained clinical evidence of healing.
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CONCLUSION
Despite these limitations, this is the only series found in the literature evaluating clavicle nonunion healing rates grafted exclusively with allograft bone substitute sources. Based on our current results, ORIF with a bone graft substitute source is a viable alternative to ICBG when treating clavicle nonunions. Our healing rates with allograft are lower than reported rates utilizing ICBG, but our method does eliminate graft-site morbidity. However, smokers may have a higher risk for failure with allograft, although this was not found to be statistically significant. When clavicle nonunions persist after surgical treatment, the failures can be catastrophic and difficult to revise. Thus, given this trend, ORIF and ICBG may better serve patients with a smoking history. We are currently enrolling patients in a prospective case series to re-examine the efficacy of ORIF with DBM in clavicular nonunions to standardize treatment and to formally evaluate patient's clinical progress with standardized outcomes measurements and complete radiographic analysis. We hope this will shed more light on this complicated problem.
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Footnotes
Source of Support: Nil Conflict of Interest: None declared. Go to:

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