IMN vs LSCH Surgery for Metastatic Bone Cancer in the Femur

Not currently recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Lymphoma, Advanced hip arthritis, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two surgical methods for treating cancer that has spread to and weakened the thigh bone (femur). The aim is to determine which surgery—long-stem cemented hemiarthroplasty (LSCH) or intramedullary nailing (IMN)—yields better outcomes in function, quality of life, pain control, and risk of complications. Individuals with a painful or broken thigh bone due to cancer, excluding lymphoma, may be suitable candidates for the trial. As an unphased trial, this study provides patients the chance to contribute to valuable research that could enhance future treatment options.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have had bevacizumab, there must be a 3-week gap between your last dose and the surgery.

What prior data suggests that these surgical techniques are safe for treating metastatic bone cancer in the femur?

Research has shown that intramedullary nailing (IMN) is a safe treatment for bone cancer that has spread to the thigh bone (femur). Studies indicate it is generally safe. One study found that the implant remained in place 94% of the time over several years, suggesting it is strong and well-accepted by the body.

Conversely, long-stem cemented hemiarthroplasty (LSCH) has been linked to some issues. Research found that using longer stems in LSCH can lead to more complications around the time of surgery compared to shorter stems. However, LSCH still offers good long-term results for many patients.

In summary, both surgeries are commonly used and have been studied for their safety. IMN usually results in fewer complications, while LSCH may present more issues during surgery but still provides long-term benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for metastatic bone cancer in the femur because they offer distinct surgical approaches that could improve patient outcomes. Intramedullary nailing (IMN) involves placing a metal rod inside the thigh bone, secured with screws, which provides a less invasive option that might lead to quicker recovery times compared to traditional methods. On the other hand, long-stem cemented hemiarthroplasty (LSCH) involves replacing the hip joint's ball with a metal ball and rod, stabilized with cement, which could offer enhanced stability and pain relief for patients with more extensive bone damage. Exploring these surgical options could lead to tailored treatment strategies that better address the diverse needs of patients with this challenging condition.

What evidence suggests that this trial's surgeries could be effective for metastatic bone cancer in the femur?

This trial will compare two surgical procedures for metastatic bone cancer in the femur: intramedullary nailing (IMN) and long-stem cemented hemiarthroplasty (LSCH). Studies have shown that IMN effectively treats cancer that has spread to the thigh bone, often allowing for quick recovery and shorter surgery times, which benefits patients with limited life expectancy. IMN is less invasive, typically resulting in fewer complications and good outcomes.

In contrast, LSCH has a high success rate, with 90.9% of implants lasting at least five years, though it may lead to more complications during surgery. Both treatments in this trial aim to improve quality of life by reducing pain and increasing mobility. ^{1 4 6 7 8}

Who Is on the Research Team?

John Healey, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with cancer that has spread to the thigh bone, causing fractures or risk of fracture. They should have a life expectancy over 1 month and not have had previous surgery in the affected area, except biopsy. Those with lymphoma or severe hip arthritis are excluded.

Inclusion Criteria

My cancer has spread to my bones or organs, confirmed by scans.

Surgeon's estimated survival ≥ 1 month

I have a painful or broken femur near the hip due to disease.

Exclusion Criteria

Estimated survival <1 month

Previous randomization for a contralateral procedure as part of this study

My cancer has not spread outside a specific hip area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo one of two types of surgeries: long-stem cemented hemiarthroplasty or intramedullary nailing

1 day

1 visit (in-person)

Postoperative Recovery

Participants recover from surgery and are monitored for complications and transfusion volume

2 weeks

Inpatient care

Follow-up

Participants are monitored for functional outcomes, quality of life, and complications at defined timepoints

12 months

5 visits (in-person or phone)

What Are the Treatments Tested in This Trial?

Interventions

• IMN
• LSCH

Trial Overview The study compares two surgeries: intramedullary nailing (IMN) and long-stem cemented hemiarthroplasty (LSCH), to see which is better for quality of life, function, pain control, and complications after femur fractures due to cancer.

How Is the Trial Designed?

Group I: long-stem cemented hemiarthroplasty (LSCH) Active Control 2 Interventions

(LSCH), "Hip, Ball, Rod and Cement" Replace the ball of the hip joint with a metal ball and a rod that is placed inside the thigh bone with cement to keep the implant in place. The study participation period for each patient is 360 days from the date of surgery and includes 5 defined timepoints that include the suture removal visit at 3 weeks and follow-up clinical visits for radiographs and rehabilitation progress checks at 6 weeks, 12 weeks, 6 months, and 12 months after surgery. At each follow-up visit, a combination of questionnaires and physical tests will be administered to assess physical function, general health status, disability level, and pain control. Some patients may be in a rehabilitation center or on hospice care and will miss their follow-up appointments. To collect data for the primary endpoint, the 6 week and/or 12 week TESS can be done over phone if necessary.

Group II: intramedullary nailing (IMN) Active Control 2 Interventions

Intramedullary nailing (IMN), "Rod and Screws" A metal rod is placed inside your thigh bone and secured in place by metal screws just below the hip and above the knee. The study participation period for each patient is 360 days from the date of surgery and includes 5 defined timepoints that include the suture removal visit at 3 weeks and follow-up clinical visits for radiographs and rehabilitation progress checks at 6 weeks, 12 weeks, 6 months, and 12 months after surgery. At each follow-up visit, a combination of questionnaires and physical tests will be administered to assess physical function, general health status, disability level, and pain control. Some patients may be in a rehabilitation center or on hospice care and will miss their follow-up appointments. To collect data for the primary endpoint, the 6 week and/or 12 week TESS can be done over phone if necessary.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

State University of New York - Upstate Medical University

Collaborator

Trials

176

Recruited

27,600+

Spectrum Health Medical Group

Collaborator

Trials

2

Recruited

770+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Montefiore Medical Center

Collaborator

Trials

468

Recruited

599,000+

Medical University of Graz

Collaborator

Trials

524

Recruited

9,334,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11352437/

Progression of Femoral Osteolytic Metastases after ... We find that 14% of nailing patients experience progression. Percutaneous salvage showed promising improvements in pain and ambulatory scores and avoided the ...

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

Metastatic bone disease in proximal femur. Outcome of ... Nailing allows rapid recovery and shorter surgical times, which might be beneficial for patients with MBD and low residual life expectancy. Pathologic fractures ...

3. ecancer.org ecancer.org/en/journal/article/698-the-current-status-of-prophylactic-femoral-intramedullary-nailing-for-metastatic-cancer

The current status of prophylactic femoral intramedullary ... A recent study showed that patients who underwent prophylactic fixation have improved post-operative outcomes than patients who underwent fixation after ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12026158/

A comprehensive evaluation of intramedullary devices in ... Intramedullary nailing (IMN) is frequently used for femoral metastases owing to its minimally invasive nature and favorable outcomes.

5. ar.iiarjournals.org ar.iiarjournals.org/content/42/2/919.abstract

Outcomes of Intramedullary Nail Fixation for Metastatic ... Conclusion: IMN fixation was durable in impending and pathologic femoral fractures. Early identification of metastases remains critical as patients treated for ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138313004348

Intramedullary nailing for treatment of pathologic femoral ... The patients' survival rate was 40% at 1 year, 25% at 2 years and 15% at 3 years. Results confirm that multiple factors related to patients and primary cancer ...

7. mdpi.com mdpi.com/2072-6694/15/17/4396

Safety and Efficacy of a Single-Stage versus Two- ... Our study is the largest and most comprehensive of its kind in supporting the safety and efficacy of a SS bilateral femur IMN approach in these select patients.

8. wjso.biomedcentral.com wjso.biomedcentral.com/articles/10.1186/s12957-016-0836-2

Intramedullary nailing has sufficient durability for metastatic ... The postoperative patient survival was 14.2 and 8.4 % at 2 and 3 years from surgery, respectively, while the implant survival rate remained 94.0 ...