Hip Surgery for Bone Cancer

(PERFORM Trial)

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michelle Ghert, MD

Disqualifiers: Femoral neck lesions, High morbidity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 day (surgery)

334 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctor to get a clear answer based on your specific situation.

What data supports the effectiveness of the treatment Internal Fixation, Resection, and Reconstruction for hip surgery in bone cancer patients?

Research shows that resection hip arthroplasty, a type of surgery similar to resection and reconstruction, allowed patients to walk without support and had no local tumor recurrence or infection. Additionally, internal fixation for hip lesions in cancer patients resulted in pain relief and improved walking ability, with low complication rates. ^{1 2 3 4 5}

Is hip surgery for bone cancer generally safe for humans?

Research shows that hip surgery for bone cancer, including procedures like resection and reconstruction, is generally safe. In studies, patients did not experience serious complications like infections, and most had good outcomes with improved mobility and pain relief. ^{1 4 6 7 8}

How does the treatment 'Internal Fixation, Resection and Reconstruction' for hip surgery in bone cancer differ from other treatments?

This treatment is unique because it combines internal fixation (stabilizing the bone with metal implants), resection (removal of the tumor), and reconstruction (rebuilding the hip area), allowing for early weight-bearing and hip motion. It is an excellent alternative to other procedures like endoprosthetic replacement or allograft reconstruction, especially for maintaining lower limb function and mobility. ^{1 2 6 9 10}

What is the purpose of this 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.

Research Team

Michelle Ghert, MD

Principal Investigator

McMaster University

Eligibility Criteria

The PERFORM trial is for patients with cancer that has spread to the hip bone. They should be fit enough for surgery and willing to follow up regularly after the procedure. Specific criteria about who can or cannot participate are not provided here.

Inclusion Criteria

Life expectancy of at least 6 months

I have lesions in the upper part of my thigh bone.

No more than 75% and no less than 25% bone loss

Exclusion Criteria

My injury is limited to the femoral neck.

My condition involves the femoral head.

A team of doctors agrees that removing my lesion completely is necessary.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either internal fixation or resection and reconstruction surgery based on randomization

1 day (surgery)

1 visit (in-person)

Follow-up

Participants attend follow-up appointments to monitor recovery and outcomes at 2 weeks, 6 weeks, 4 months, 6 months, 9 months, and 12 months after surgery

12 months

6 visits (in-person)

Long-term follow-up

Participants are monitored for long-term outcomes such as mortality, days at home, and physical function

Up to 12 months post-surgery

Treatment Details

Interventions

• Internal Fixation
• Resection and reconstruction

Trial Overview This study compares two surgical methods for treating hip bone affected by cancer: stabilizing it with metal hardware (internal fixation) versus removing part of the bone and possibly replacing the joint (resection and reconstruction).

Participant Groups

Group I: Resection and Reconstruction Experimental Treatment 1 Intervention

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.

Group II: Internal Fixation Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Michelle Ghert, MD

Lead Sponsor

Trials

1

Recruited

330+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

References

1. England pubmed.ncbi.nlm.nih.gov

Resection hip arthroplasty for malignant pelvic tumor. Outcome in 5 patients followed more than 2 years. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Surgical treatment of pathologic hip lesions in patients with metastatic disease. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the role and cost-effectiveness of end-of-life orthopaedic interventions in cancer patients with skeletal metastases to the hip. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Why Do Patients Undergoing Extremity Prosthetic Reconstruction for Metastatic Disease Get Readmitted? [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Is endoprosthesis safer than internal fixation for metastatic disease of the proximal femur? A systematic review. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

[Surgical therapy of pelvic tumors]. [2006]

7. Poland pubmed.ncbi.nlm.nih.gov

Reconstruction of large bone defects with arthroplasty in the treatment of bone tumors of the hip joint. [2007]

8. China pubmed.ncbi.nlm.nih.gov

[Clinical Significance of Hip Rotation Center Location after Reconstruction with Modular Hemipelvic Prostheses for Pelvic Tumor]. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Treatment of intra-articular hip malignancy with extra-articular resection, preservation of the acetabular columns, and total hip arthroplasty. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Late complications and long-term outcomes following aseptic revision of a hip arthroplasty performed for oncological resection. [2022]