Metastatic Bone DiseasePERFORMNCT06863129
Proximal FEmur Reconstruction or Internal Fixation fOR Metastases (PERFORM) Trial
A study testing Internal Fixation and Resection and reconstruction in people with Metastatic Bone Disease, run by Michelle Ghert, MD at 13 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Bone Disease
- What is being tested?
- Internal Fixation and Resection and reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 1 Feb 2025to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 4 countries
United States7 sites, 4 recruiting
- Active, not recruiting
Albany Medical Center
Albany, New York, 12206
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Steven Thorpe, 303-724-5375, steven.thorpe@cuanschutz.edu
Veronica Butler, VERONICA.BUTLER@CUANSCHUTZ.EDU
- Active, not recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Samir Sabharwal, MD, 513-584-1000, sabharsr@ucmail.uc.edu
Samir Sabharwal
- Withdrawn
Good Samaritan Regional Medical Center
Corvallis, Oregon, 97330
- Recruiting
Parkview Packnett Family Cancer Institute
Fort Wayne, Indiana, 46845
Ashley Romine, 260-266-9156, ashley.romine@parkview.com
Chris Johnson
- Recruiting
Oregon Health and Science University Hospital
Portland, Oregon, 97239
Rebecca Smith, 503-494-2963, smithreb@ohsu.edu
Kenneth Gundle
Canada4 sites, 1 recruiting
- Not yet recruiting
Foothills Medical Centre
Calgary, Alberta
Joseph Kendal, 403-944-4793, jkkendal@ucalgary.ca
Nkiru Ezeonyeka, nkiru.ezeonyeka@ucalgary.ca
- Withdrawn
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
- Active, not recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
- Active, not recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Austria1 site, 1 recruiting
- Recruiting
Medical University Graz
Graz
Andreas Leithner, 43-316-385-31790, andreas.leithner@medunigraz.at
Andreas Leithner
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90450050
Julie Cerutti Pestilho, +5551983081317, juliecerutti@gmail.com
Ricardo Becker
About this study
Official title: 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:
- Does removing and replacing part of the bone work better than just stabilizing it with metal hardware?
- Does removing and replacing the bone help reduce problems like cancer coming back or the metal hardware breaking?
Read more
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.
Read the 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.
- Conditions
- Metastatic Bone Disease
- Being tested
- Internal Fixation, Resection and reconstruction
- Medical subject headings
- Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal FixationProcedure or surgery
Internal Fixation
Resection and reconstructionProcedure or surgery
Resection and reconstruction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Internal Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 12 months
Collected through case report forms via electronic medical records and patient/ caregiver self-reported.
Measured: 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)
Measured: From enrollment to one year follow-up post surgery.
Number of days at home
Patient self- reported via patient diary.
Measured: From enrollment to one year follow-up post surgery.
Secondary outcomes (1)
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).
Measured: From enrollment to one year follow-up post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Feb 2025
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Bone DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michelle Ghert, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Sponsor-investigator, Michelle Ghert, MD, McMaster University
- Investigators
- Michelle Ghert, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863129
- Sponsor's protocol ID
- GHRT03
- Acronym
- PERFORM
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol will be shared with other researchers via the study website.
Publications
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.
PubMed 34677238Ruggieri P, Breda A, Angelini A. What's New in Musculoskeletal Tumor Surgery. J Bone Joint Surg Am. 2026 Oct 1. doi: 10.2106/JBJS.26.01114. Online ahead of print. No abstract available.
PubMed 42821659
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal FEmur Reconstruction or Internal Fixation fOR Metastases (PERFORM) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06863129
- Acronym / sponsor ID
- PERFORM / GHRT03
- Conditions
- Metastatic Bone Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Michelle Ghert, MDUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does removing and replacing part of the bone work better than just stabilizing it with metal hardware?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resection and Reconstruction | Experimental | Procedure: Resection and reconstructionIf 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. |
| Internal Fixation | Active comparator | Procedure: Internal FixationIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal FixationInternal Fixation | Procedure or surgery | Internal Fixation |
| Resection and reconstructionResection and reconstruction | Procedure or surgery | Resection and Reconstruction |
Primary outcome
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.
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)
Number of days at home
Time frame: From enrollment to one year follow-up post surgery.
Patient self- reported via patient diary.
1 secondary outcome
Quality of life- PROMIS-PROPr (PROMIS-Preference) health utility score
Time frame: From enrollment to one year follow-up post surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 34677238Axelrod 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.
- Derived from this study: PubMed 42821659Ruggieri P, Breda A, Angelini A. What's New in Musculoskeletal Tumor Surgery. J Bone Joint Surg Am. 2026 Oct 1. doi: 10.2106/JBJS.26.01114. Online ahead of print. No abstract available.
- Individual participant dataSharing planned: Yes. Protocol will be shared with other researchers via the study website.
Related trials for Metastatic Bone Disease
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 1/2
ALT-100 Monoclonal Antibody (mAb) in Bone-Predominant Metastatic Androgen Pathway Modulation Resistant (APMR) Prostate Cancer -- The ALTAR-100 Trial
Prostate Cancer Metastatic to Bone
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Ghert, MD principal investigator
McMaster University
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal Fixation and Resection and reconstruction in people with Metastatic Bone Disease, run by Michelle Ghert, MD at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada, Austria, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia Virag, MA (905- 521-2100 ext. 47105, viragoe@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 12 months (time frame: From enrollment to one year follow-up post surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06863129, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.