IMN vs LSCH Surgery for Metastatic Bone Cancer in the Femur

Recruiting at 5 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

73 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to look at two different types of surgeries regularly used for treating cancer that has spread to and weakened the thigh bone (femur). Because it is not known which of these surgeries is best, the investigators will compare the results of the two procedures. They are looking to see if differences exist (after surgery) in function, quality of life, pain control, and possible complications.

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 data supports the effectiveness of this treatment for metastatic bone cancer in the femur?

Surgical stabilization of the femur in patients with metastatic tumors has been shown to improve quality of life by reducing pain and allowing early movement. In a study, patients experienced significant pain relief and improved performance scores after surgery, with many surviving more than five months postoperatively. ^{1 2 3 4 5}

Is intramedullary nailing (IMN) safe for treating metastatic bone cancer in the femur?

Intramedullary nailing (IMN) is generally considered safe for treating fractures in the femur due to metastatic bone cancer, with studies showing low rates of complications and no implant failures. Single-stage IMN procedures have been associated with fewer medical complications compared to two-stage procedures. ^{6 7 8 9 10}

How does the treatment IMN differ from other treatments for metastatic bone cancer in the femur?

Intramedullary nailing (IMN) is a treatment for metastatic bone cancer in the femur that involves inserting a metal rod inside the bone to stabilize it, allowing for early movement and pain relief. It is unique because it offers a less invasive option compared to endoprosthetic reconstruction (EPR), which involves replacing part of the bone with a prosthesis, and it may have different implications for lung metastasis compared to other surgical techniques. ^{3 6 8 9 10}

Research Team

John Healey, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

My cancer has not spread outside a specific hip area.

Previous randomization for a contralateral procedure as part of this study

Timeline

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)

Treatment Details

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.

Participant Groups

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+

References

1. China pubmed.ncbi.nlm.nih.gov

[Analysis of clinical prognostic factor for 99 patients with metastases of proximal femur]. [2017]

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

Extent of Surgery Does Not Influence 30-Day Mortality in Surgery for Metastatic Bone Disease: An Observational Study of a Historical Cohort. [2021]

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

Functional outcome following surgical treatment of metastatic tumors involving the femur. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Analysis of implants for metastatic bone tumors of the proximal femur: A retrospective study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Surgical management of metastatic disease of the proximal femur. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Does surgical technique influence the burden of lung metastases in patients with pathologic long bone fractures? [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of a Single-Stage versus Two-Stage Intramedullary Nailing for Synchronous Impending or Pathologic Fractures of Bilateral Femur for Oncologic Indications: A Systematic Review. [2023]

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

Treatment Modalities for Pathologic Fractures of the Proximal Femur Pertrochanteric Region: A Systematic Review and Meta-Analysis of Reoperation Rates. [2019]

9. Greece pubmed.ncbi.nlm.nih.gov

Outcomes of Intramedullary Nail Fixation for Metastatic Disease: Impending and Pathologic Fractures. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Intramedullary nailing has sufficient durability for metastatic femoral fractures. [2018]