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RecruitingNCT03261544Updated Jul 15, 2026

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

An observational study in Sarcoma, Bone Metastases and Proximal Femur Replacement, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by Duke University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
16 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sarcoma
  • Bone Metastases
  • Proximal Femur Replacement

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03

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

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

    Motion data collected from gait analysis testing will be evaluated with OpenCap.

    Time frame: up to 24 months postoperatively

06

Study locations

1 of 1 sites recruiting
  • Duke University
    Durham, North Carolina 27710, United States
    • Elizabeth Sachs · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT03261544
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Aug 25, 2017
Start date
Nov 10, 2017
Primary completion
Jun 2027 (estimated)
Completion
Nov 2028 (estimated)
Last update
Jul 15, 2026

Study contacts

Elizabeth Sachs, MS
Contact
elizabeth.sachs@duke.edu
9196609849
William Eward, MD, DVM
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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