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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMichelle Ghert, MD

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Internal Fixation
  • Resection and reconstruction

Treatment groups

334 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Michelle Ghert, MD

Lead sponsor

McMaster University

Sponsor institution

Canadian Cancer Society (CCS)

Collaborator