Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique. The investigators hypothesize that those patients who receive reattachment of the abductors directly into the prosthesis will have better functional outcomes overall. Furthermore, the investigators plan to develop a simple, cost effective, and reproducible method to assess abductor function at clinical post-operative visits through plain radiographs.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Patients treated for proximal femur replacements at Duke University Medical Center by Orthopaedic Oncology trained surgeons. The Duke DEDUCE database will be used to identify retrospective patients using the above mentioned CPT codes. Individual chart review of the electronic medical record will then be used to identify those receiving a proximal femur replacement. Maximum number of charts to be reviewed in the study will be 300. Of these 300 charts, the investigators plan to consent 25 subjects who have return appointments scheduled. The investigators also plan to consent 25 preoperative patients, for a total of 50 subjects.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Proximal Femur Replacement The proximal femur is a common site for primary bone sarcomas and metastatic disease. The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique. |
Procedure: Proximal Femur Replacement
The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique.
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Outcome Measures
Primary Outcome Measures
- Gait Analysis [up to 12 months postoperatively]
gait analysis as measured by software in gait lab
Secondary Outcome Measures
- Functional Outcome Questionnaire [up to 5 years postoperatively]
outcome questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
• Has undergone or is scheduled for proximal femur replacement by an Ortho Oncology surgeon
Exclusion Criteria:
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Non-ambulatory before or after the procedure
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Subjects who, in the opinion of the investigator, have not or likely will not complete at least some portion of the investigator's recommended follow-up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Duke University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00082717