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RecruitingObservational

Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?

NCT ID: NCT03261544Sponsor: Duke UniversityLast updated: 2025-08-22

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.

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.

Arms & interventions

  • ProcedureProximal 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.

Outcome measures

Primary

  • The Musculoskeletal Tumor Society (MSTS) score

    The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.

    Time frame: up to 24 months postoperatively

  • Harris Hip Score

    The Harris Hip Score (HHS) is a clinician-based outcome measure that is frequently used for the evaluation of patients following a Total Hip Arthroplasty (THA). The survey has ten questions and scores ranging from 0-100, with higher scores representing less dysfunction and better outcomes.

    Time frame: up to 24 months postoperatively

  • Number of patients with an implant-related complication as reported on the adverse event form upon participation completion.

    The adverse event form records the occurence of implant-related complications that occur during study participation.

    Time frame: up to 24 months postoperatively

Secondary

  • Gait Analysis as reported on the study's case report form

    Time frame: up to 24 months postoperatively

Eligibility criteria

Sex: AllAge: 16 Years to 75 YearsHealthy volunteers: No
Inclusion Criteria: • Has undergone or is scheduled for proximal femur replacement by an Ortho Oncology surgeon Exclusion Criteria: * Non-ambulatory before or after the procedure * 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

Study locations (1)

Duke University

Durham, North Carolina, 27710

Recruiting
Elizabeth Sachs · Contact