IMN vs LSCH Surgery for Metastatic Bone Cancer in the Femur
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.12345Why 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.14678Who 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo one of two types of surgeries: long-stem cemented hemiarthroplasty or intramedullary nailing
Postoperative Recovery
Participants recover from surgery and are monitored for complications and transfusion volume
Follow-up
Participants are monitored for functional outcomes, quality of life, and complications at defined timepoints
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?
2
Treatment groups
Active Control
(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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
State University of New York - Upstate Medical University
Collaborator
Spectrum Health Medical Group
Collaborator
University of Rochester
Collaborator
Mayo Clinic
Collaborator
Walter Reed National Military Medical Center
Collaborator
Duke University
Collaborator
Montefiore Medical Center
Collaborator
Medical University of Graz
Collaborator
Citations
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 ...
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 ...
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 ...
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.
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 ...
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 ...
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.
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 ...
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