Proximal FEmur Reconstruction or Internal Fixation fOR Metastases (PERFORM) Randomized Controlled Trial
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.
Description
The Proximal FEmur Resection or Internal Fixation fOR Metastases (PERFORM) trial is a multi-centre randomized controlled trial that aims to test a paradigm shift in the oncological surgical management of patients with metastatic bone disease (MBD) of the proximal femur. The PERFORM trial will aim to determine if resection and endoprosthetic reconstruction improves patient-important outcomes compared to internal fixation in patients with MBD of the proximal femur. MBD afflicts the majority of patients with advanced stage carcinomas and is the most common oncologic disease of the skeleton. The…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 perioperativ…
Interventions
- ProcedureInternal Fixation
Internal Fixation
- ProcedureResection and reconstruction
Resection and reconstruction
Locations (6)
- Parkview Packnett Family Cancer InstituteFort Wayne, Indiana
- Good Samaritan Regional Medical CenterCorvallis, Oregon
- Oregon Health and Science University HospitalPortland, Oregon
- Cliniques Universitaires Saint-LucBrussels
- Hospital de Clínicas de Porto AlegrePorto Alegre, Rio Grande do Sul
- AOU Città della Salute e della Scienza CTO hospitalTorino, To