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

Duke University

Status: Enrolling

Conditions: Sarcoma; Proximal Femur Replacement; Bone Metastases

Treatments: Procedure: Proximal Femur Replacement

Study type: Observational

Funder types: Other

Identifiers

NCT03261544

Pro00082717

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Proximal Femur Replacement

Description:

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.

Treatment:

Procedure: Proximal Femur Replacement