Resection and reconstruction versus internal metal fixation for metastatic disease of the upper femur

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

This trial tests whether removing and replacing the affected part of the upper thigh bone works better than stabilizing it with metal hardware for people with metastatic cancer in the proximal femur.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 334 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: McMaster University (Academic / other)
• Locations: 6 sites (Fort Wayne, Indiana and 5 other locations)
• Trial ID: NCT06863129 on ClinicalTrials.gov

What this trial studies

PERFORM is a randomized, multicenter trial that assigns patients with metastatic lesions of the proximal femur to either internal fixation with nails/plates or to resection and endoprosthetic reconstruction. Eligible patients must meet specific surgical fitness and life-expectancy criteria and are followed at regular intervals after surgery (2 weeks, 6 weeks, 4 months, 6 months, and 9 months). The trial measures patient-important outcomes including need for reoperation, mechanical failure of hardware, local disease control, mobility, and quality of life. By comparing these two common surgical strategies, the study seeks to identify which approach best reduces complications and preserves function for patients likely to live months to years with metastatic bone disease.

Who should consider this trial

Good fit: Ideal candidates are adults with metastatic lesions in the proximal femur (not isolated to the femoral neck or involving the femoral head), who are fit for surgery with an expected survival of at least six months and who have agreed with their surgeon to operative management.

Not a fit: Patients with lesions limited to the femoral neck or involving the femoral head, those judged high risk for surgery, or those with life expectancy under six months are unlikely to qualify for or benefit from the approaches tested.

Why it matters

Potential benefit: If successful, it could lower the risk of hardware failure and repeat surgeries and improve mobility and quality of life for patients with proximal femur metastases.

How similar studies have performed: Retrospective and cohort studies suggest reconstruction may reduce reoperation compared with fixation, but randomized evidence is limited, making this a relatively novel randomized comparison.

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

Where this trial is running

Fort Wayne, Indiana and 5 other locations

• Parkview Packnett Family Cancer Institute — Fort Wayne, Indiana, United States (Recruiting)
• Good Samaritan Regional Medical Center — Corvallis, Oregon, United States (Recruiting)
• Oregon Health and Science University Hospital — Portland, Oregon, United States (Not_yet_recruiting)
• Cliniques Universitaires Saint-Luc — Brussels, Belgium (Not_yet_recruiting)
• Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
• AOU Città della Salute e della Scienza CTO hospital — Torino, To, Italy (Not_yet_recruiting)

Study contacts

• Principal investigator: Michelle Ghert, MD — McMaster University
• Study coordinator: Olivia Virag, MA

Conditions Metastatic Bone Disease