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Clinical trial Recruiting at 6 sites Interventional Ages 18 and up

Resection and reconstruction versus internal metal fixation for metastatic disease of the upper femur

Official title: Proximal FEmur Reconstruction or Internal Fixation fOR Metastases (PERFORM) Randomized Controlled Trial

Run by McMaster University · NCT06863129 · Data updated 2026-11-12

This trial tests whether removing and replacing the affected part of the upper thigh bone works better than stabilizing it with metal hardware for people with metastatic cancer in the proximal femur.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment334 (estimated)
SponsorMcMaster University
Academic / other
Locations13 sites (Aurora, Colorado and 12 other locations)
StatusRecruiting
StartedFebruary 1, 2025
Main results expectedJune 1, 2029
Study endsJune 1, 2030
Registry record updatedJuly 8, 2026
Trial IDNCT06863129 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with metastatic lesions in the proximal femur (not isolated to the femoral neck or involving the femoral head), who are fit for surgery with an expected survival of at least six months and who have agreed with their surgeon to operative management.

Probably not a fit

Patients with lesions limited to the femoral neck or involving the femoral head, those judged high risk for surgery, or those with life expectancy under six months are unlikely to qualify for or benefit from the approaches tested.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PERFORM is a randomized, multicenter trial that assigns patients with metastatic lesions of the proximal femur to either internal fixation with nails/plates or to resection and endoprosthetic reconstruction. Eligible patients must meet specific surgical fitness and life-expectancy criteria and are followed at regular intervals after surgery (2 weeks, 6 weeks, 4 months, 6 months, and 9 months). The trial measures patient-important outcomes including need for reoperation, mechanical failure of hardware, local disease control, mobility, and quality of life. By comparing these two common surgical strategies, the study seeks to identify which approach best reduces complications and preserves function for patients likely to live months to years with metastatic bone disease.

Why it matters

Potential benefit: If successful, it could lower the risk of hardware failure and repeat surgeries and improve mobility and quality of life for patients with proximal femur metastases.

How similar studies have gone: Retrospective and cohort studies suggest reconstruction may reduce reoperation compared with fixation, but randomized evidence is limited, making this a relatively novel randomized comparison.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Where it's running

  • University of Colorado Hospital
    Aurora, Colorado, United States     Recruiting
  • Parkview Packnett Family Cancer Institute
    Fort Wayne, Indiana, United States     Recruiting
  • University of Cincinnati Medical Center
    Cincinnati, Ohio, United States     Recruiting
  • Oregon Health and Science University Hospital
    Portland, Oregon, United States     Recruiting
  • Medical University Graz
    Graz, Austria     Recruiting
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul, Brazil     Recruiting
Show 7 more locations
  • University of Maryland Medical Center
    Baltimore, Maryland, United States     Active not recruiting
  • Albany Medical Center
    Albany, New York, United States     Active not recruiting
  • Good Samaritan Regional Medical Center
    Corvallis, Oregon, United States     Withdrawn
  • Foothills Medical Centre
    Calgary, Alberta, Canada     Not yet recruiting
  • Mount Sinai Hospital
    Toronto, Ontario, Canada     Active not recruiting
  • Hôpital Maisonneuve-Rosemont
    Montreal, Quebec, Canada     Withdrawn
  • McGill University Health Centre
    Montreal, Quebec, Canada     Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.