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NCT Number: NCT03261544

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

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.

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Key information

Conditions

Sarcoma Bone Metastases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Proximal Femur Replacement

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Elizabeth Sachs

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The Musculoskeletal Tumor Society (MSTS) score

    Time frame: up to 24 months postoperatively

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

  2. Harris Hip Score

    Time frame: up to 24 months postoperatively

    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.

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

    Time frame: up to 24 months postoperatively

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

Secondary outcomes

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

    Time frame: up to 24 months postoperatively

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

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Sachs, MS

CONTACT

[email protected]

9196609849

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2017
Primary completion
2027
Study completion
2028
First posted
Aug 25, 2017
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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