RecruitingNot ApplicableNCT06863129

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

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


Sponsor

Michelle Ghert, MD

Enrollment

334 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREInternal Fixation

Internal Fixation

PROCEDUREResection 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06863129


Related Trials