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Cemented versus uncemented

hemiarthroplasty for intracapsular hip


fractures
A RANDOMISED CONTROLLED TRIAL IN 400 PATIENTS

M. I. Parker, We undertook a prospective randomised controlled trial involving 400 patients with a
G. Pryor, displaced intracapsular fracture of the hip to determine whether there was any difference in
K. Gurusamy outcome between treatment with a cemented Thompson hemiarthroplasty and an
uncemented Austin-Moore prosthesis. The surviving patients were followed up for between
From Peterborough two and five years by a nurse blinded to the type of prosthesis used.
and Stamford The mean age of the patients was 83 years (61 to 104) and 308 (77%) were women. The
Hospital NHS Trust, degree of residual pain was less in those treated with a cemented prosthesis (p < 0.0001)
Peterborough, three months after surgery. Regaining mobility was better in those treated with a cemented
England implant (p = 0.005) at six months after operation. No statistically significant difference was
found between the two groups with regard to mortality, implant-related complications,
re-operations or post-operative medical complications.
The use of a cemented Thompson hemiarthroplasty resulted in less pain and less
deterioration in mobility than an uncemented Austin-Moore prosthesis with no increase in
complications.

Displaced intracapsular fractures of the neck uncertainty as to the relative advantages and
of the femur are commonly treated by hemi- disadvantages of using bone cement. We there-
arthroplasty. Orthopaedic surgeons are divided fore undertook a large randomised controlled
as to the relative merits of cemented versus trial comparing an uncemented Austin-Moore
uncemented prostheses in these patients. prosthesis with a cemented Thompson hemi-
Cementing the prosthesis provides more secure arthroplasty in patients with a displaced intra-
fixation and may result in less residual pain and capsular fracture of the proximal femur, with a
better function. However, the insertion of minimum follow-up of two years’.
cement complicates the operation and carries
the risk of cardiovascular collapse when the Materials and Methods
„ M. I. Parker, MD, FRCS(Edin),
Orthopaedic Research Fellow cement is introduced into the femur.1 So far, six All patients presenting to our institution with a
„ G. Pryor, MS, FRCS, small randomised controlled trials involving displaced intracapsular fracture of the proxi-
Orthopaedic Surgeon
Orthopaedic Department 549 patients have been summarised in a mal femur were considered for inclusion in the
Peterborough and Stamford Cochrane Review on this subject. This study. Patients with senile dementia were
Hospital NHS Foundation Trust,
Thorpe Road, Peterborough reported that patients with cemented prosthe- included with the consent of their next of kin.
PE3 6DA, UK. ses have less pain and a tendency to better The inclusion and exclusion criteria are listed
„ K. Gurusamy, MS, MRCS, mobility than those with uncemented prosthe- in Table I. All patients with an undisplaced or
Clinical Research Fellow
University Department of
ses.1 The authors concluded that there was lim- minimally displaced intracapsular fracture
Surgery ited evidence that cementing a prosthesis in were excluded from the study and treated by
Royal Free Hospital, Pond
Street, London NW3 2QG, UK.
place may reduce post-operative pain and lead internal fixation, as were all patients aged less
to better mobility. They highlighted the need than 60 years with a displaced fracture and
Correspondence should be sent
to Dr M. J. Parker; e-mail: for further well-conducted randomised con- those aged between 60 and 75 years in whom
Martyn.Parker@pbh-tr.nhs.uk trolled trials. there was no impairment of mobility (defined
©2010 British Editorial Society The two most common types of hemiarthro- as the ability to walk out of the house unaided)
of Bone and Joint Surgery
doi:10.1302/0301-620X.92B1.
plasty used for the treatment of a displaced immediately prior to the injury.
22753 $2.00 intracapsular fracture in the United Kingdom The study had ethical approval and the sup-
J Bone Joint Surg [Br]
are the uncemented Austin-Moore prosthesis port of the hospital research and development
2010;92-B:116-22. and the cemented Thompson hemiarthro- committee. Patients were randomised by the
Received 27 April 2009;
Accepted after revision 27
plasty.2 The continued use of a mixture of opening of a sealed opaque numbered enve-
August 2009 uncemented and cemented prostheses reflects lope, prepared by a person independent of the

116 THE JOURNAL OF BONE AND JOINT SURGERY


CEMENTED VERSUS UNCEMENTED HEMIARTHROPLASTY FOR INTRACAPSULAR HIP FRACTURES 117

Table I. Inclusion and exclusion criteria for participants in the study

Inclusion criteria
Displaced intracapsular fracture in a patient aged over 60

Exclusion criteria
Undisplaced or minimally displaced intracapsular fracture
Patients aged less than 60
Patients aged 60 to 75 years with no restriction in mobility at the time of injury
Patients who declined to participate
Patients with senile dementia for whom the assent of their next of kin was not obtained
Patients with a pathological fracture from a tumour or Paget’s disease of bone
Previous treatment to the same hip for a fracture
Patients who were not considered to be fit for either of the surgical procedures
Patients with significant arthritis of the hip that necessitated treatment with a total hip replacement
Patients admitted when the lead trialist was not available to supervise the surgical procedure

study, containing details of the procedure to be undertaken. Table II. Mobility assessment tool
After randomisation all patients had to stay in the group to 1. Could they get about the house?
which they had been allotted, regardless of any deviations 2. Was the patient able to get out of the house?
from the treatment protocol, and all results were analysed 3. Could they do their shopping?
on an intention-to-treat basis. All operations were per-
For each of the three questions:
formed or supervised by one orthopaedic surgeon (MIP)
Without any difficulty - score 3
and all by a standard anterolateral approach with repair of On their own with an aid - score 2
the joint capsule. The Austin-Moore prosthesis used Only with someone else’s help - score 1
(Stryker/Howmedica Ltd, Newbury, United Kingdom) was Not at all. Bed or chair bound - score 0
generally of the standard size, but if the femur was slender,
a narrow-stem implant was used. The Thompson hemi-
arthroplasty (Corin Ltd, Cirencester, United Kingdom) was
inserted after the femur had been prepared by reaming and residential care (partial care within an institution) or nurs-
saline irrigation. A Hardinge cement restrictor was used ing care (full nursing care or hospital in-patient). For the
and Palacos bone cement with gentamicin (Schering-Plough follow-up assessments, pain was assessed using a visual
Ltd, Welwyn Garden City, United Kingdom) was inserted in analogue scale of one to ten at the outpatient clinic visit,
a retrograde manner into the femur using a cement gun. All with least pain scoring one, and also using a scale of one to
patients received peri-operative antibiotic prophylaxis and six in which one was no pain; two occasional and slight
14 days of low molecular weight heparin as thrombo- pain; three pain when starting walking but then getting bet-
embolic prophylaxis. After surgery all patients were mobi- ter with occasional analgesia; four with no or little pain at
lised as soon as they were able, with no restrictions on hip rest, pain with activities, frequent mild analgesia; five con-
movements or weight-bearing. They were discharged home stant but bearable pain, stronger analgesia used occasion-
as soon as their general condition allowed. ally; and six constant pain with frequent strong analgesia.5
Patients were initially reviewed six weeks after discharge. The one to six assessment scale was used for telephone
Subsequent assessments were by telephone at three, six, follow-up assessments. The patient’s walking ability imme-
nine and 12 months, and thereafter every year for up to five diately prior to the fall was assessed using a mobility scale
years. All assessments were undertaken by a nurse who was of 0 to nine,6,7 where nine represented full mobility indoors
blinded to the treatment undertaken. For those patients and outdoors without walking aids and 0 defined a bed-
who could not be contacted, enquiry was made via their bound patient (Table II). At each follow-up assessment the
next of kin or their registered medical practitioner. Finally, time until 16 activities of daily living were regained was
if the patient could not be contacted, enquiry was made to also assessed.
the Office of Population Census Service. All surviving Before commencing the study a power calculation was
patients had a mean follow-up of 3.7 years (2 to 5). Three undertaken using the primary outcome of degree of residual
patients were lost to follow-up, two after four years and pain at one year. The calculation was based on reducing the
one after three years. number of patients with a pain score of ≥ 3 by 10%. Allow-
On admission the patient’s mental state was assessed ing for deaths and loss to follow-up, it was estimated that
using a ten-point mental test score and their physical state 200 patients were required in each group.
by the American Society of Anaesthesiologists (ASA) Statistical analysis. Binary outcomes for the two groups
score.3,4 Residential status was defined as living in their were analysed using Fisher’s exact test, and continuous out-
own home (including warden-controlled accommodation), comes with the Mann-Whitney U test. Survival outcomes

VOL. 92-B, No. 1, JANUARY 2010


118 M. I. PARKER, G. PRYOR, K. GURUSAMY

1100 patients admitted with an intracapsular hip fracture


between March 2001 and November 2006

Excluded for not meeting inclusion criteria * (700)


Undisplaced/minimally displaced (281)
Patient too young/fit (104)
Pathological fracture (17)
No consent (9)
Treated conservatively (17)
Unfit for hemiarthroplasty (35)
Lead trialists not available (268)
Other reason (12)

Randomised (400)

Allocated to cemented hemiarthroplasty (200) Allocated to uncemented hemiarthroplasty (200)


Treated as per protocol (189)
Had internal fixation (4) Treated as per protocol (189)
Prosthesis not cemented (4) Had internal fixation (2)
Cemented bipolar hemiarthroplasty used (1) Prosthesis cemented (7)
Trochanteric fracture treated (1) Pathological fracture (2)
Pathological fracture (1)

Completed follow-up (74)


Completed follow-up (79)
Died during follow-up period (125)
Died during follow-up period (119)
Lost to follow-up (1) Lost to follow-up (2)

Fig. 1

Participant flow diagram.* Patients may have been excluded for more than one reason.

were calculated using the Kaplan-Meier method, and 11 patients in the uncemented group did not have treat-
comparison between the groups was performed using the ment as defined in the study protocol. Seven were felt to
Kaplan-Meier log-rank test.8 A p-value of < 0.05 was con- have a prosthesis that was loose at the time of surgery,
sidered statistically significant. either because of a large femoral cavity or from an opera-
tive fracture of the femur, and the prosthesis was therefore
Results cemented in place. Two patients, initially considered fit
Patients were recruited over a five-year period. The rea- for hemiarthroplasty, were considered unfit at the time of
sons for 700 patients not being included in the study are surgery and treated by reduction and internal fixation. A
shown in Figure 1. Among the 400 randomised patients, further two patients were later found to have a patho-
11 in the cemented group did not have treatment as logical fracture secondary to a tumour.
defined in the study protocol. Five patients were consid- Patient characteristics. The characteristics of the two groups
ered to be unfit for a cemented hemiarthroplasty immedi- of patients are detailed in Table III. None of the differences
ately prior to or during surgery, having previously been between the two groups was statistically significant.
considered fit for both procedures. Four of these were Operative details. The operative details and total hospital
treated by reduction and internal fixation, and one had stay for the two groups are shown in Table IV. The mean
an uncemented Austin-Moore hemiarthroplasty. Four duration of surgery was approximately seven minutes lon-
patients were found to have a femur that was too narrow ger for those who had a cemented prosthesis. There were no
to accommodate a Thompson prosthesis. Three were differences in requirements for blood transfusion related to
treated with an uncemented narrow-stem Austin-Moore the type of procedure. The total hospital stay was the time
and one with a cemented bipolar hemiarthroplasty. One spent on the orthopaedic and any other wards, including
patient was found at the time of surgery to have a trochan- medical and rehabilitation wards, until discharge from hos-
teric fracture and not an intracapsular fracture, but was pital. The readmissions included were only those for condi-
still treated with a cemented Thompson hemiarthroplasty, tions directly related to the hip fracture. Total hospital stay
and one further patient was later found to have a patho- was found to be four days shorter for those treated with a
logical fracture from a secondary tumour. A further cemented prosthesis.

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CEMENTED VERSUS UNCEMENTED HEMIARTHROPLASTY FOR INTRACAPSULAR HIP FRACTURES 119

Table III. Characteristics of patients

Cemented Thompson Uncemented Moore


Number of patients 200 200
Mean age (range) 83 (61 to 97) 83 (62 to 104)
Male (%) 39 (20) 53 (27)
From own home (%) 147 (74) 145 (73)
Mean mobility score 5.7 5.9
Mean mental test score 5.8 5.9
Mean ASA* grade 2.7 2.7
Mean haemoglobin on admission (g/l) 128 126
* ASA, American society of anaesthesiologists

Table IV. Operative details and hospital stay

Cemented Thompson Uncemented Moore p-value*


Spinal anaesthesia (%) 113 (57) 112 (56) 1.0
General anaesthesia (%) 83 (42) 85 (43) 1.0
Local anaesthesia (%) 4 (2) 3 (2) 1.0
Mean duration of surgery in mins (SD) 55.4 (13.4) 48.5 (13.2) < 0.0001
Mean duration of anaesthesia in mins (SD) 67.5 (13.5) 60.1 (13.3) < 0.0001
Required blood transfusion (%) 35 (18) 25 (13) 0.20
Mean units transfused (SD) 0.39 (0.87) 0.27 (0.72) 0.32
Operative fracture of the femur 0 14 < 0.0001
Retained cement in acetabulum 2 0 0.50
Orthopaedic ward stay in days (SD) 16.1 (14.2) 17.1 (12.4) 0.028
Initial total hospital stay in days (SD) 18.8 (21.4) 22.6 (23.5) 0.006
Hospital stay and readmissions in days (SD) 20.3 (22.3) 24.7 (25.8) 0.004
* calculated with the Mann-Whitney U and Fisher’s exact tests

Table V. General complications encountered

Cemented Thompson Uncemented Moore p-value*


Confusion 2 2 1.0
Pneumonia 1 9 0.02
Pressure sores 5 12 0.07
Deep-vein thrombosis 2 2 1.0
Pulmonary embolism 2 0 0.5
Cerebrovascular accident 2 1 1.0
Gastrointestinal bleed 4 0 0.12
Cardiac failure 4 6 0.75
Acute renal failure 0 1 1.0
Myocardial infarction 1 2 1.0
Acute cardiac arrhythmia 0 1 1.0
Acute confusion state 2 2 1.0
Intestinal obstruction 0 1 1.0
Clostridia diarrhoea 0 1 1.0
Peritonitis 1 0 1.0
* calculated with Fisher’s exact tests

In the uncemented group there were 14 intraoperative cement retained in the acetabulum which was only seen on
femoral fractures. Of these, six had the Austin-Moore the post-operative radiograph. No further treatment was
cemented in place during the procedure, and one had a revi- necessary for this. In addition to the details given in Table IV,
sion a few days later, when the implant was converted to a one patient had a cardiac arrest on the operating table after
cemented prosthesis. For the remaining patients the fractures insertion of the cement. The patient however made an
were considered not to require any change in treatment and uneventful recovery.
were managed with the standard mobilisation regimen. In General complications. The general medical complications
the cemented hemiarthroplasty group, two patients had are listed in Table V. There were no statistically significant

VOL. 92-B, No. 1, JANUARY 2010


120 M. I. PARKER, G. PRYOR, K. GURUSAMY

Table VI. Wound healing complications and later complications related to surgery

Cemented Thompson Uncemented Moore p-value*


Wound haematoma 2 1 1.0
Superficial wound infection 4 3 1.0
Deep wound infection 6 5 1.0
Dislocation 2 1 1.0
Drainage of infection or haematoma 3 4 1.0
Internal fixation revised to hemiarthroplasty 1 2 1.0
Revision arthroplasty for periprosthetic fracture 0 3 0.25
Revision for pain to THR† 3 7 0.34
Revision for dislocation to THR 1 1 1.0
Girdlestone arthroplasty 1 1 1.0
Girdlestone arthroplasty and later THR 2 0 0.5
Any re-operation 11 18 0.25
* calculated with Fisher’s exact tests
† THR, total hip replacement

differences between the two groups apart from an increased 1


incidence of pneumonia in those treated with an uncemented Cemented p = 0.776
prosthesis. Cumulative survival (%) hemiarthroplasty
Uncemented
Wound healing and implant-related complications. Later 0.8
hemiarthroplasty
implant-related complications are listed in Table VI. Three
of the six patients who were considered unfit for hemi-
arthroplasty at the time of surgery and were therefore 0.6
treated by reduction and internal fixation, developed non-
union and had the fixation revised to a hemiarthroplasty. 0.4
The other revisions to hemiarthroplasty or total hip
replacement were all for pain in the hip caused by either
loosening of the prosthesis or acetabular wear. In total 21 0.2
further anaesthetics were required in 11 patients in the
cemented group compared to 21 further anaesthetics in 18
0
patients in the uncemented group.
Mortality. The mortality at one year for the cemented prosthesis 0 12 24 36 48 60
was 25% and for the uncemented was 28% (Fig. 2). At no time Time (mths)
was there any statistically significant difference between the
Fig. 2
groups.
Residual pain. The mean degree of residual pain for the Survival curve showing mortality related to the type of procedure.
patients assessed is shown in Table VII and Figure 3. The
group of patients treated by the cemented prosthesis had
lower pain scores, signifying less pain, for all the assessments,
although only the results on the visual analogue scale, at eight out of a car (mean 9.1 weeks vs 15.9 weeks (p = 0.006)
weeks and at three, six, 12 and 24 months by telephone assess- and the ability to go shopping without assistance (mean
ment were statistically significant. 16.6 weeks vs 27.0 weeks, p = 0.0002).
Mobility. The differences between the admission mobility Return home. Of the 200 patients 173 (86%) treated with
score and that at each of the post-operative follow-up a cemented implant compared to 164 of 200 patients
assessments are shown in Table VIII. The scores were all (82%) with an uncemented implant returned to their orig-
lower for the cemented prosthesis, signifying that patients inal residence after their initial hospital stay (p = 0.27). A
so treated regained a better degree of mobility. total of 13 patients (7%) treated with an uncemented
Activities of daily living. There was no statistically signifi- prosthesis were unable to be discharged to their original
cant difference between the two groups for the 16 activi- residence or required a more dependent residential status
ties assessed, except for three in which function was (p = 0.121). The remaining patients died in hospital. Of
regained more rapidly in those treated by cemented the surviving patients one year after injury, 126 of 143
arthroplasty. These activities were the ability to bend (88%) in the cemented group were still in their original
down and pick up an object from the floor (mean 15.7 residence, as opposed to 114 of 138 (83%) in the unce-
weeks vs 23.6 weeks, p = 0.0045), the ability to get in and mented group (p = 0.24).

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CEMENTED VERSUS UNCEMENTED HEMIARTHROPLASTY FOR INTRACAPSULAR HIP FRACTURES 121

Table VII. Mean degree of residual pain at the follow-up assessments (SD, number)

Time from surgery to assessment Cemented Thompson Uncemented Moore p-value*


Eight weeks visual analogue 2.5 (1.8, 110) 3.1 (2.1, 102) 0.034
Eight weeks 2.3 (1.2, 160) 2.5 (1.3, 160) 0.155
Three months 1.9 (1.2, 164) 2.5 (1.3, 156) < 0.0001
Six months 1.8 (1.2, 147) 2.4 (1.4, 142) 0.001
Nine months 1.9 (1.3, 136) 2.2 (1.3, 133) 0.029
One year 1.8 (1.2, 141) 2.2 (1.3, 131) 0.006
Two years 1.7 (1.2, 96) 2.1 (1.4, 100) 0.034
Three years 1.7 (1.3, 70) 1.8 (1.2, 81) 0.258
Four years 1.6 (1.2, 47) 1.7 (1.2, 50) 0.95
Five years 1.7 (1.1, 26) 2.0 (1.3, 32) 0.30
* calculated with the Mann-Whitney U test

Cemented Uncemented
Many outcome measures were used in this study (approxi-
3 mately 50 comparisons). This may result in an α error, in which,
when a p-value of < 0.05 is chosen as the level of statistical sig-
Pain score

2.5
nificance, one result in 20 may show such a p-value. Using a
2 Bonferroni correction, a p-value of 0.05/50 (i.e., 0.001) may be
1.5 used. If this is applied to the key outcome measure of residual
1
pain, this still remains statistically significant. Hence, the key
finding in this study of reduced residual pain for the cemented
9 months
3 months

6 months
8 weeks

5 years
2 years

3 years

4 years
1 year

prosthesis is extremely unlikely to be due to statistical chance.


The outcome of secondary surgery, particularly revision of
the implant, was not significantly different between the two
Fig. 3
groups, although there was a tendency to more revision
Graph showing mean pain scores related to the type of treatment given. arthroplasties in the uncemented group. The outcome of revi-
sion rate for this population is not so significant as that for
elective hip arthroplasty, as the elderly population in this study
are less likely to undergo a revision arthroplasty, even if signif-
Discussion icant symptoms of residual pain exist. Data from the Austra-
This study is the largest randomised trial to date on this lian National Joint Replacement Registry9 have demonstrated
topic and confirms the results of the previous smaller stud- a reduced need for revision surgery for a cemented Thompson
ies of patients with an intracapsular hip fracture which prosthesis compared with an uncemented Austin-Moore. For
found that a cemented hemiarthroplasty leads to less resid- 15 000 registered cases, the rate of revision surgery was signif-
ual pain and a better return of mobility than an uncemented icantly higher (p < 0.001) for the uncemented prosthesis. The
prosthesis.1 We were able to demonstrate that the margin- Australian database found that four years after surgery the
ally increased operation time and the potential operative rate of revision was approximately 4% for the Thompson
complications associated with cement were not detrimen- versus 6% for the Austin-Moore prosthesis. This is compara-
tal. Indeed, the reverse was true, with a clear trend to fewer ble with the finding in this study of a rate of revision to total
general medical complications, fewer re-operations and a hip replacement of 3% for the cemented Thompson and 6%
shorter hospital stay with the cemented prosthesis. for the uncemented Austin-Moore.
The strengths of this study include the broad entry criteria, Previously published randomised trials comparing cemented
the large number of patients included, standardisation of treat- and uncemented hemiarthroplasties for patients with a fracture
ment procedures, the lack of patients lost to follow-up, and the of the hip have been identified and summarised in the
blinded assessment of outcome. The most important outcomes Cochrane Review on this subject.1 Sonne-Holm, Walter and
measured were mortality, pain and return of function. At the Jensen,10 in 1982, compared the results of a cemented and an
initial outpatient visit we assessed pain using both a visual ana- uncemented Austin-Moore hemiarthroplasty in 112 patients.
logue scale and a pain score as described by Charnley.5 For this There was no difference in mortality between the two groups.
elderly population it was found that the Charnley pain score Better walking ability and less pain was observed in those
was the most appropriate method of assessment for follow-up treated with the cemented prosthesis. Similar findings were
by telephone. We are not aware of any studies that have specif- recorded in a later study of 50 patients which compared a
ically validated the Charnley pain score, but the questions used cemented and an uncemented bipolar hemiarthroplasty.11
form the basis of most of the arthroplasty assessment scores There was no difference in mortality between the groups, but
which have been widely used and validated. significantly less pain in those treated with the cemented

VOL. 92-B, No. 1, JANUARY 2010


122 M. I. PARKER, G. PRYOR, K. GURUSAMY

Table VIII. Mean reduction in mobility scores (SD, number)

Time from surgery to assessment Cemented Thompson Uncemented Moore p-value*


Eight weeks visual analogue 2.1 (2.2, 168) 2.5 (2.2, 165) 0.10
Three months 1.8 (2.1, 168) 2.7 (2.0, 158) 0.07
Six months 1.4 (1.9, 150) 2.2 (1.9, 144) 0.005
Nine months 1.3 (1.8, 142) 1.9 (2.0, 135) 0.016
One year 1.3 (1.9, 143) 2.0 (2.0, 137) 0.004
Two years 1.9 (2.0, 104) 2.0 (2.2, 107) 0.58
Three years 2.0 (2.0, 73) 2.4 (2.3, 83) 0.42
Four years 2.2 (2.1, 50) 2.7 (2.1, 52) 0.26
Five years 2.4 (2.3, 29) 2.5 (2.1, 34) 0.81
* calculated with the Mann-Whitney U test

prosthesis. Walking ability was also superior with the The study was supported by a grant from the Peterborough Hospital Hip Frac-
ture Fund. We would like to thank the research nurses N. Smith, M. Norman, D.
cemented prosthesis. Santini et al12 also compared a Parker and K. Ruggerio for their help with the study.
cemented and an uncemented bipolar hemiarthroplasty in No benefits in any form have been received or will be received from a com-
mercial party related directly or indirectly to the subject of this article.
106 patients. Again, there was no difference in mortality or
functional activity between the two groups. Two studies
involving a total of 190 patients compared a cemented with References
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