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

NCT06863129 | Recruiting DMC

• 1 other identifier: GHRT03
• Study Type: interventional
• Target: 334
• Locations: 4 countries
• Sites: 13

Brief 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:

• 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

Outcome Measures

Primary Outcomes (3)

• Mortality at 12 months

  Collected through case report forms via electronic medical records and patient/ caregiver self-reported.

  From enrollment to one year follow-up post surgery.

• Physical function

  Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Physical Function score: To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair? Answer options include: Completely (best outcome); Mostly; Moderately; A little; Not at all (worst outcome)

  From enrollment to one year follow-up post surgery.

• Number of days at home

  Patient self- reported via patient diary.

  From enrollment to one year follow-up post surgery.

Secondary Outcomes (1)

• Quality of life- PROMIS-PROPr (PROMIS-Preference) health utility score

  From enrollment to one year follow-up post surgery.

Study Arms (2)

Resection and Reconstruction

EXPERIMENTAL

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.

Procedure: Resection and reconstruction

Internal Fixation

ACTIVE COMPARATOR

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.

Procedure: Internal Fixation

Interventions

Internal Fixation PROCEDURE

Internal Fixation

Internal Fixation

Resection and reconstruction PROCEDURE

Resection and reconstruction

Resection and Reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Michelle Ghert, MD: lead
• Canadian Cancer Society (CCS): collaborator

Study Sites (13)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Parkview Packnett Family Cancer Institute

Fort Wayne, Indiana, 46845, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

ACTIVE NOT RECRUITING

Albany Medical Center

Albany, New York, 12206, United States

ACTIVE NOT RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Good Samaritan Regional Medical Center

Corvallis, Oregon, 97330, United States

WITHDRAWN

Oregon Health and Science University Hospital

Portland, Oregon, 97239, United States

RECRUITING

Medical University Graz

Graz, Austria

RECRUITING

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90450050, Brazil

RECRUITING

Foothills Medical Centre

Calgary, Alberta, Canada

NOT YET RECRUITING

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

ACTIVE NOT RECRUITING

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

WITHDRAWN

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

ACTIVE NOT RECRUITING

Related Publications (1)

• Axelrod D, Gazendam AM, Ghert M. The Surgical Management of Proximal Femoral Metastases: A Narrative Review. Curr Oncol. 2021 Sep 28;28(5):3748-3757. doi: 10.3390/curroncol28050320.

  PMID: 34677238 BACKGROUND

MeSH Terms

Conditions

Bone Diseases

Interventions

Fracture Fixation, Internal; Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Michelle Ghert, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Virag, MA

CONTACT

905- 521-2100; viragoe@mcmaster.ca

Hadia Farrukh

CONTACT

905- 521-2100; farrukhh@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: March 7, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Throughout study period.
• Access Criteria: Publicly available.

Locations

AU (1); CA (4); US (7); BR (1)