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RECRUITING
NCT06863129
NA

Proximal FEmur Reconstruction or Internal Fixation fOR Metastases (PERFORM) Trial

Sponsor: Michelle Ghert, MD

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to find out if removing and replacing part of the hip bone works better than using metal hardware to stabilize the bone in patients whose cancer has spread to the hip. The main questions are: 1. Does removing and replacing part of the bone work better than just stabilizing it with metal hardware? 2. Does removing and replacing the bone help reduce problems like cancer coming back or the metal hardware breaking? Researchers will compare two treatments: using metal rods and plates to stabilize the bone (internal fixation) versus removing part of the bone and possibly replacing the hip joint (resection and reconstruction) to see if the second option causes fewer problems. Participants will: * Be randomly assigned to one of two groups (internal fixation or resection and reconstruction). * Have one of the two surgeries based on which group they're in. * Go to follow-up appointments with the study doctor at 2 weeks, 6 weeks, 4 months, 6 months, 9 months, and 12 months after surgery.

Official title: Proximal FEmur Reconstruction or Internal Fixation fOR Metastases (PERFORM) Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

334

Start Date

2025-02-01

Completion Date

2030-06-01

Last Updated

2025-11-10

Healthy Volunteers

No

Interventions

PROCEDURE

Internal Fixation

Internal Fixation

PROCEDURE

Resection and reconstruction

Resection and reconstruction

Locations (6)

Parkview Packnett Family Cancer Institute

Fort Wayne, Indiana, United States

Good Samaritan Regional Medical Center

Corvallis, Oregon, United States

Oregon Health and Science University Hospital

Portland, Oregon, United States

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

AOU Città della Salute e della Scienza CTO hospital

Torino, To, Italy