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

NCT03261544 | Recruiting

• 1 other identifier: Pro00082717
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma; Bone Metastases; Proximal Femur Replacement

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  up to 24 months postoperatively

Secondary Outcomes (1)

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

  up to 24 months postoperatively

Study Arms (1)

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

Interventions

Proximal Femur Replacement PROCEDURE

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.

Proximal Femur Replacement

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Has undergone or is scheduled for proximal femur replacement by an Ortho Oncology surgeon

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• William Eward, MD, DVM

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Sachs, MS

CONTACT

9196609849; elizabeth.sachs@duke.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: November 10, 2017
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-07

Locations

US (1)