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

Recruiting now · Not applicable

Conditions studied: Metastatic Bone Disease

In brief

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.

Key facts

Study ID

NCT06863129

Run by

Michelle Ghert, MD

People needed

334

Starts

2025-02-01

Expected to finish

2030-06-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Life expectancy of at least 6 months
• Lesions in the proximal femur (femoral neck, intertrochanteric region, subtrochanteric region, and combinations thereof)
• Low or intermediate risk for perioperative morbidity and/or mortality
• No more than 75% and no less than 25% bone loss
• Mutual (patient and physician) decision to perform surgical management of an impending or realized pathologic fracture due to MBD of the proximal has been made.

You may not qualify if…

• Lesions isolated to the femoral neck
• Lesion with any femoral head involvement
• High risk for perioperative morbidity and/or mortality
• Multidisciplinary decision that resection of the entire lesion would be indicated

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
• Parkview Packnett Family Cancer Institute — Fort Wayne, Indiana, United States (enrolling)
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
• Oregon Health and Science University Hospital — Portland, Oregon, United States (enrolling)
• Medical University Graz — Graz, Austria (enrolling)
• Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• Mount Sinai Hospital — Toronto, Ontario, Canada
• Hôpital Maisonneuve-Rosemont — Montreal, Quebec, Canada
• McGill University Health Centre — Montreal, Quebec, Canada
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Albany Medical Center — Albany, New York, United States
• Foothills Medical Centre — Calgary, Alberta, Canada
• Good Samaritan Regional Medical Center — Corvallis, Oregon, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.