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

Conditions

• Metastatic Bone Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Internal Fixation — PROCEDURE
  Internal Fixation
• Resection and reconstruction — PROCEDURE
  Resection and reconstruction

Study Details

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.

Key Dates

Start date

Feb 1, 2025

Status verified

Mar 2025

Primary completion

Jun 1, 2029

Completion

Jun 1, 2030

Study Design

Enrollment

334 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Resection and Reconstruction
  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.
• Active Comparator: Internal Fixation
  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.

Primary Outcome Measure

Mortality at 12 months [ Time Frame: From enrollment to one year follow-up post surgery. ]

Central Contacts

• Olivia Virag, MA
  905- 521-2100
  [email protected]
• Hadia Farrukh
  905- 521-2100
  [email protected]

Locations (3)

Find similar trials in Fort Wayne, IN

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