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

NCT06863129 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2025-11-10

No results posted yet for this study

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.

Conditions

  • Metastatic Bone Disease

Interventions

PROCEDURE

Internal Fixation

Internal Fixation

PROCEDURE

Resection and reconstruction

Resection and reconstruction

Sponsors & Collaborators

  • Canadian Cancer Society (CCS)

    collaborator OTHER

  • Michelle Ghert, MD

    lead OTHER

Principal Investigators

  • Michelle Ghert, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2029-06-01
Completion
2030-06-01

Countries

  • United States
  • Belgium
  • Brazil
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06863129 on ClinicalTrials.gov