Hip Surgery for Bone Cancer

(PERFORM Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Michelle Ghert, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Michelle Ghert, MD

No Placebo Group

Trial Summary

What is the purpose of 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.

Research Team

Michelle Ghert, MD

Principal Investigator

McMaster University

Eligibility Criteria

The PERFORM trial is for patients with cancer that has spread to the hip bone. They should be fit enough for surgery and willing to follow up regularly after the procedure. Specific criteria about who can or cannot participate are not provided here.

Inclusion Criteria

Life expectancy of at least 6 months

I have lesions in the upper part of my thigh bone.

No more than 75% and no less than 25% bone loss

Exclusion Criteria

My injury is limited to the femoral neck.

My condition involves the femoral head.

A team of doctors agrees that removing my lesion completely is necessary.

Treatment Details

Interventions

• Internal Fixation (Procedure)
• Resection and reconstruction (Procedure)

Trial Overview This study compares two surgical methods for treating hip bone affected by cancer: stabilizing it with metal hardware (internal fixation) versus removing part of the bone and possibly replacing the joint (resection and reconstruction).

Participant Groups

Group I: Resection and Reconstruction Experimental Treatment 1 Intervention

If a participant is randomized to the Resection and Reconstruction treatment arm, a proximal femoral resection or hip arthroplasty will be carried out as per standard surgical practice. The type of endoprosthesis used for reconstruction will be at the treating surgeon's discretion. Acetabular reconstruction (if any), the surgical approach, and the intra-operative use of cement and other adjuvants for disease control will also be at the discretion of the treating surgeon.

Group II: Internal Fixation Active Control 1 Intervention

If the participant is randomized to the Internal Fixation treatment arm, the surgery will involve the stabilization of the remaining bone with either an intramedullary nail, plate or screw fixation. All standard surgical principles of stable internal fixation will be followed. The type of fixation, the surgical approach, and the intra-operative use of cement and other adjuvants for disease control will be at the treating surgeon's discretion.

Who Is Running the Clinical Trial?

Michelle Ghert, MD

Lead Sponsor

Trials

1

Recruited

330+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+