An interventional study of Internal Fixation and Resection and reconstruction in Metastatic Bone Disease, sponsored by Michelle Ghert, MD. Recruiting at 13 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Michelle Ghert, MD · Not applicable, Interventional, and Treatment
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:
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:
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.
177 studies on the registry are indexed under Bone Diseases; 38 are open to participants now.
This study's planned enrollment of 334 is above the median of 53 across 113 interventional studies indexed under Bone Diseases.
Browse Bone Diseases studies →This is the only study on the registry with Michelle Ghert, MD as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Resection and reconstruction
Mortality at 12 months
Collected through case report forms via electronic medical records and patient/ caregiver self-reported.
Time frame: 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)
Time frame: From enrollment to one year follow-up post surgery.
Number of days at home
Patient self- reported via patient diary.
Time frame: From enrollment to one year follow-up post surgery.
Quality of life- PROMIS-PROPr (PROMIS-Preference) health utility score
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).
Time frame: From enrollment to one year follow-up post surgery.
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Plan to share: Yes — Protocol will be shared with other researchers via the study website.
Supporting information: Study protocol
Time frame: Throughout study period.
Access criteria: Publicly available.
Data sharing details ↗ · www.performtrial.com
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