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Recruiting NCT06863129

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

Trial Parameters

Condition Metastatic Bone Disease
Sponsor Michelle Ghert, MD
Study Type INTERVENTIONAL
Phase N/A
Enrollment 334
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-02-01
Completion 2029-06-01
Interventions
Internal FixationResection and reconstruction

Brief 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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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