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Proximal FEmur Reconstruction or Internal Fixation fOR Metastases (PERFORM) Trial
Sponsor: Michelle Ghert, MD
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
Conditions
Interventions
Internal Fixation
Internal Fixation
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