Clinical trial NCT06863129: Proximal FEmur Reconstruction or Internal Fixation fOR Metastases (PERFORM) Trial
Official title: Proximal FEmur Reconstruction or Internal Fixation fOR Metastases (PERFORM) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metastatic Bone Disease
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2025-03-07
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Eligibility 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

Primary outcomes:
measure: Mortality at 12 months
timeFrame: From enrollment to one year follow-up post surgery.
measure: Physical function
timeFrame: From enrollment to one year follow-up post surgery.
measure: Number of days at home
timeFrame: From enrollment to one year follow-up post surgery.
Secondary outcomes:
measure: Quality of life- PROMIS-PROPr (PROMIS-Preference) health utility score
timeFrame: From enrollment to one year follow-up post surgery.
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Parkview Packnett Family Cancer Institute
state: Indiana
city: Portland
country: United States
facility: Oregon Health and Science University Hospital
state: Oregon
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza CTO hospital
state: To
Study officials:
affiliation: McMaster University
name: Michelle Ghert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.