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

November 7, 2025 updated by: Michelle Ghert, MD

Proximal FEmur Reconstruction or Internal Fixation fOR Metastases (PERFORM) Randomized Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Proximal FEmur Resection or Internal Fixation fOR Metastases (PERFORM) trial is a multi-centre randomized controlled trial that aims to test a paradigm shift in the oncological surgical management of patients with metastatic bone disease (MBD) of the proximal femur. The PERFORM trial will aim to determine if resection and endoprosthetic reconstruction improves patient-important outcomes compared to internal fixation in patients with MBD of the proximal femur.

MBD afflicts the majority of patients with advanced stage carcinomas and is the most common oncologic disease of the skeleton. The proximal femur is the most commonly affected location in the appendicular skeleton and is a source of significant morbidity affecting patient mobility and quality of life.

Stabilization of an impending or actual fracture of the proximal femur resulting from MBD has historically been achieved with internal fixation using intramedullary nails, plates and screws. This approach is meant to provide enough stability to ambulate without pain for the remainder of the cancer patient's life. However, many patients with metastatic cancer are experiencing longer life spans due to advances in systemic treatment options. Therefore, the traditional methods of stabilizing bones in the setting of MBD may no longer be meeting the standard of outcomes required for patients who can now live for years with their disease. Internal fixation, which is by nature a palliative surgery, results in disease relapse in nearly 20% of patients, most often due to local MBD recurrence. Alternatively, complete resection of the affected bone followed by reconstruction with an endoprosthesis, although more invasive and conferring higher surgical risks than an internal fixation procedure, reduces the risk of cancer recurrence at the surgical site to approximately 3%, thereby avoiding the deleterious effects on patient function and quality of life. However, the evidence supporting the use of resection and endoprosthetic reconstruction of the proximal femur, although promising, is retrospective and methodologically weak, resulting in a gap in the necessary evidence to change practice.

The PERFORM trial will aim to determine if resection and endoprosthetic reconstruction improves patient-important outcomes compared to internal fixation in patients with MBD of the proximal femur.

THe Methods Centre and proposed clinical sites collectively possess the methodological, logistical and clinical expertise required to successfully carry out the PERFORM trial. Ultimately, this trial has the potential to effect significant changes in orthopaedic oncology clinical practice and improve the oncologic, functional, and quality of life outcomes of patients with cancers that have metastasized to their proximal femur. While the introduction of a more invasive yet more durable procedure would represent a paradigm shift in the approach to this patient population, the challenge investigators confront is to support this practice change with high-quality, concrete evidence.

Study Type

Interventional

Enrollment (Estimated)

334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90450050
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
        • Principal Investigator:
          • Ricardo Becker
        • Sub-Investigator:
          • Bruno Pereira Antunes
        • Sub-Investigator:
          • Eduardo da Silva Rodrigues
        • Sub-Investigator:
          • Gabriella Moojen
  • Italy
    • To
      • Torino, To, Italy, 10126
        • Not yet recruiting
        • AOU Città della Salute e della Scienza CTO hospital
        • Contact:
        • Principal Investigator:
          • Michele Boffano
  • United States
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Packnett Family Cancer Institute
        • Contact:
        • Principal Investigator:
          • Chris Johnson
    • Oregon
      • Corvallis, Oregon, United States, 97330
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Oregon Health and Science University Hospital
        • Contact:
        • Sub-Investigator:
          • Yee-Cheen Doung, MD
        • Principal Investigator:
          • Kenneth Gundle
        • Sub-Investigator:
          • Duncan Ramsey, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Resection and reconstruction
Resection and reconstruction
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.
Procedure: Internal Fixation
Internal Fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at 12 months
Time Frame: From enrollment to one year follow-up post surgery.
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
Time Frame: From enrollment to one year follow-up post surgery.
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
Time Frame: From enrollment to one year follow-up post surgery.
Patient self- reported via patient diary.
From enrollment to one year follow-up post surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life- PROMIS-PROPr (PROMIS-Preference) health utility score
Time Frame: From enrollment to one year follow-up post surgery.
PROMIS-PROPr (PROMIS-Preference) utility score - encompassing mental and physical health, and quality of life. The PROMIS-PROPr combines scores from seven PROMIS domains into a single preference-based score (also called a health utility score), which captures the preferences of the general adult population. The total number of items that the patient answers are 31. This instrument gives four different scores: health utility score, domain level scores (one for each of the following domains: physical function, anxiety, depression, fatigue, sleep disturbance, social roles and activities, pain interference, cognition, and pain intensity), physical component score, and a mental component score. Answer options include: Not at all (1); A little bit (2); Somewhat (3); Quite a bit (4); Very much (5).
From enrollment to one year follow-up post surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michelle Ghert, MD

Collaborators

Canadian Cancer Society (CCS)

Investigators

  • Principal Investigator: Michelle Ghert, MD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

November 10, 2025

Last Update Submitted That Met QC Criteria

November 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHRT03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Protocol will be shared with other researchers via the study website.

IPD Sharing Time Frame

Throughout study period.

IPD Sharing Access Criteria

Publicly available.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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