Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT03261544

Conditions

Sarcoma

Bone Metastases

Proximal Femur Replacement

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

Proximal Femur Replacement

Study Details

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

Study ID

NCT03261544

Start date

Nov 10, 2017

Status verified date

Jul, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • The Musculoskeletal Tumor Society (MSTS) score [ Time Frame: up to 24 months postoperatively ]
  • Harris Hip Score [ 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. [ Time Frame: up to 24 months postoperatively ]

Central Contacts and Locations

Central contacts

Elizabeth Sachs, MS

9196609849elizabeth.sachs@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27710

More Information

Sponsor

Duke University

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-07-15.