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Research Summary

Purpose of the study: To compare the outcomes of ……………….. in patients who underwent
………………. arthroplasty.

Background & significance: Support the scientific aims of the research.

1. The disease population.
2. The clinically unmet need.
3. Why this research is important.
4. The rationale for performing this research.
5. Citations for existing literature that supports the rationale for performing this research.
6. Unpublished data, if any, that supports the conduct of this research.
7. How research in this protocol is different from existing research or literature.

Design & procedures: This study will be a retrospective review of patients over the age of 18 with a
history of ………………………between the years January 1, 2000 through January 1, 2015. Patients with
pathologic ……., …….. or a ………………….. will be excluded from the study. Approximately 200
charts will be reviewed for this study.

Selection of Subjects: We will identify subjects for the study groups by querying Duke Hospital database
for all patients over the age of 18 with ……………… following ……………… between 1-1-2000 and 1-
1-2015 that were treated with ………………………. Pertinent ICD-9 Diagnosis codes are as follows:
99644, List all that apply. Pertinent ICD-9 Procedure codes are as follows: List all that apply. Pertinent
CPT codes are as follows: List all that apply.

Subjects who underwent ……………… will not be included. Once eligible subjects have been identified,
we will retrospectively collect demographics, injury data, and follow-up information from the medical
records. Once post-operative information has been collected on all subjects, we will analyze the data to
determine the differences in outcomes, cost, and mortality between ………… and …………….. patient
groups.

Subject recruitment and compensation: This is a retrospective review; therefore, subjects will not be
recruited or compensated for inclusion in this study.
Consent process: Not applicable. Since this study is a retrospective review and does not involve
prospective enrollment of subjects no consent is required. A Request for Waiver of Consent and HIPAA
Authorization and Decedent Research Notification has been submitted to the Institutional Review Board
(IRB).

Subject’s capacity to give legally effective consent: Not applicable. Since this study is a retrospective
review and does not involve prospective enrollment of subjects no consent is required. A Request for
Waiver of Consent and HIPAA Authorization and Decedent Research Notification has been submitted to
the IRB.

Study Interventions: Only medical records and images will be reviewed, there are no study
interventions.

Risk/benefit assessment: Risks associated with the procedures in question have already been explained
to patients prior to them providing informed consent to undergo the proposed procedure. No further

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surgical risks will be imposed to patients. The only risk associated with this proposed study includes use
of secure medical records. To ensure that patient confidentiality is maintained, all data retrieval will be
performed by the principal investigator or assigned researchers using password-secured computers at
Duke University Hospital. Each patient will be assigned a subject ID code that will be linked to their
Medical record number. This will be generated using RedCap database and will be stored on a standalone
database server hosted by Duke Health Technology Services (DHTS) and will only be accessible to the
key personnel on this study.

There is no direct benefit provided to patients included in this study as it is a retrospective chart review.
However, we hope that the information learned from this study will benefit other patients with similar
condition in the future

Costs to the subject, and compensation: Not applicable. This study is a retrospective review and does
not involve any costs to subjects.

Data Analysis & Statistical Considerations: Data will be summarized using standard descriptive
statistics including the mean, standard deviation, median, quartiles and range for continuous variables and
counts and percentages for categorical data. Study interventions for continuous variables will be
compared using either a t-test or Wilcoxon rank sum test, depending on the normality of the distributions.
Categorical data will be compared using either the chi-square or Fisher’s exact test in the presence of
small cell counts (< 5). Comparison of implant failure rates will employ Kaplan-Meier methods as
follow-up times may vary. SAS version 9.2 or higher will be used for all analyses. A p-value ≤0.05 will
be considered statistically significant for all comparisons.

Data & Safety monitoring: There are no patient safety issues as this is a retrospective chart review.

Data storage & confidentiality: Patient safety will be maintained by removing all identifying
information during chart review and using only secure computers and networks for data collection and
storage. Patients will be assigned a new identifying number for database organization purposes that will in
no way be associated with any patient identifiers. The code list containing each patient’s new assigned
number will be stored in RedCap database, on a standalone database server, hosted by Duke Health
Technology Services (DHTS).

Staff from Duke Office of Clinical Research (DOCR) will build a RedCap database for data collection.
All data obtained for this study will be stored directly into the RedCap database on DHTS server. This
database will only be accessible to the principal investigator and approved research assistants. Staff from
DOCR will act as an intermediary to match the variables with each patient in a de-identified manner.
These DOCR staff will not participate in the research otherwise. All patient identifiers will be removed
for database storage, statistical analysis and data reporting. Protected health information will not be used
for any other purposes than those described in this protocol without obtaining further IRB approval. This
information will be used for research purposes only and patients will never be contacted regarding
information obtained through chart review. A designated statistician from Biostatistics and Bioinformatics
department will provide support with statistical analysis. The adequacy of the Research Data Security
Plan (RDSP) will be evaluated and approved by the Ortho Surgery CRU prior to study conduct.
Any publications or presentations that result from this research will not identify any subjects individually,
and will present data in aggregate form only.

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