Hip Surgery for Bone Cancer

(PERFORM Trial)

Recruiting at 5 trial locations

Overseen By Hadia Farrukh

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of hip surgeries for individuals whose cancer has spread to the hip bone. The researchers aim to determine if replacing part of the hip bone (resection and reconstruction) is more effective than using metal hardware for stabilization (internal fixation). They will compare outcomes such as cancer recurrence and metal breakage. Suitable candidates for this trial include those with cancer in the upper thigh bone (but not in the hip joint) who, along with their doctor, have decided on surgery. Participants will be randomly assigned to one of the two surgeries and will attend follow-up appointments over a year. As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially improve future treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that patients who underwent surgeries using metal rods and plates to fix bones showed a good survival rate. The metal implants remained in place for most individuals, with 92.9% lasting at least a year. This indicates that the procedure is generally safe and has few complications.

For surgeries involving partial hip bone replacement, research shows successful patient outcomes. Long-term studies found these surgeries effective, with no loosening of the artificial hip component. This suggests the surgery is also generally safe.

Both treatments have demonstrated safety for individuals with bone cancer that has spread to the hip. While any surgery carries risks, evidence indicates these methods are generally safe for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for bone cancer in the hip involve either stabilizing the bone with hardware or replacing it entirely. Researchers are excited about the Internal Fixation approach because it offers a method to stabilize the existing bone using hardware like nails, plates, or screws, which might preserve more of the patient's natural bone structure. On the other hand, the Resection and Reconstruction technique is unique because it involves removing the affected bone and reconstructing the hip with an endoprosthesis, potentially providing a more durable and stable solution. Both methods allow for personalized surgical approaches and the use of cement or other adjuvants, giving surgeons flexibility to tailor the procedure to the patient's specific condition.

What evidence suggests that this trial's treatments could be effective for bone cancer in the hip?

This trial will compare two surgical approaches for hip bone cancer: Internal Fixation and Resection and Reconstruction. Research has shown that removing and replacing part of the hip bone, known as resection and reconstruction, might lead to better long-term results for patients. Studies suggest this approach can improve function and possibly extend survival compared to internal fixation, which uses metal rods and plates to stabilize the bone. However, resection and reconstruction carry a higher risk of infection, with rates between 5% and 15%. Internal fixation is less invasive but may not be as effective in the long run, especially for mobility and reducing complications. Both treatments have their advantages and disadvantages, and ongoing research aims to determine which method is more effective overall. ^{1 2 6 7 8}

Who Is on the Research Team?

Michelle Ghert, MD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/94568-hip-arthroplasty-outcomes-in-patients-with-metastatic-bone-disease

Hip Arthroplasty Outcomes in Patients with Metastatic ... In our cohort, the median survival was 10.4 months and 53.3% of patients survived to one year postoperatively. This is consistent with these and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10950198/

Hip Arthroplasty Outcomes in Patients with Metastatic Bone ... There were 11 reoperations in five patients and six dislocations. Median survival was 10.4 months and one-year overall survival was 53.3%. There ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2212137425000521

Metastatic bone disease in proximal femur. Outcome of ... Potter et al. reported that patients with primary bone tumors exhibited statistically better functional outcomes than those with metastatic disease, with mean ...

4. eor.bioscientifica.com eor.bioscientifica.com/view/journals/eor/10/11/EOR-2024-0131.xml

Comparative outcomes of internal fixation versus prosthetic ... The study indicates that prosthesis reconstruction may offer superior long-term functional outcomes and extended survival compared with IF, ...

5. pcori.org pcori.org/research-results/2024/comparing-arthroplasty-and-internal-fixation-reducing-death-improving-ambulation-and-increasing-days-home-after-minimally-displaced-femoral-neck-fracture

Comparing Arthroplasty and Internal Fixation for Reducing ... This study compares the effectiveness of arthroplasty (total hip replacement) versus internal fixation (fixing a fracture with plates and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2949705124000306

Hip fracture and cancer: descriptive epidemiological study ... Approximately one in ten patients with PFF in this study were undergoing cancer treatment. Moreover, one in four patients with PFF were cancer-related.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12587033/

Comparative outcomes of internal fixation versus prosthetic ... These outcomes include survival time, reoperation rate, complication rate, operative time, blood loss, and MSTS score. Surgery methods are ...

8. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/213376

Medical Complications and Outcomes After Hip Fracture ... Most patients had no medical complications after hip fracture repair. Serious cardiac and pulmonary complications were equally important in frequency, ...