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Procedure

IMN vs LSCH Surgery for Metastatic Bone Cancer in the Femur

N/A

Waitlist Available

Led By John Healey, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients presenting for orthopaedic evaluation with a painful impending pathologic femur fracture or displaced pathologic femur fracture in the intertrochanteric, pertrochanteric, or subtrochanteric region of the proximal femur. The anatomic region of interest is defined by a line drawn from the base of the femoral neck to 5 cm below the base of the lesser trochanter or 2 diaphyseal shaft widths, whichever is greater.

All cancer diagnoses, except lymphoma, will be eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is comparing two surgeries for cancer that has spread to the thigh bone. They will compare results in function, quality of life, pain control, and complications.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects from these surgeries may include pain at the surgery site, infection risks, issues related to anesthesia, blood clots in legs or lungs (thromboembolism), prolonged wound healing or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My cancer diagnosis is not lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

differences in postoperative functional outcomes

Secondary outcome measures

differences in transfusion volume

postoperative complications

Trial Design

2Treatment groups

Active Control

Group I: long-stem cemented hemiarthroplasty (LSCH)Active Control2 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 Control2 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,547 Total Patients Enrolled

2 Trials studying Metastases

384 Patients Enrolled for Metastases

State University of New York - Upstate Medical UniversityOTHER

172 Previous Clinical Trials

27,259 Total Patients Enrolled

1 Trials studying Metastases

2 Patients Enrolled for Metastases

Spectrum Health Medical GroupUNKNOWN

1 Previous Clinical Trials

700 Total Patients Enrolled

Media Library

IMN (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02164019 — N/A

Metastases Research Study Groups: long-stem cemented hemiarthroplasty (LSCH), intramedullary nailing (IMN)

Metastases Clinical Trial 2023: IMN Highlights & Side Effects. Trial Name: NCT02164019 — N/A

IMN (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02164019 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographic areas is this investigation being conducted?

"This trial has 6 enrolment sites, including the Montefiore Medical Center in Bronx, Memorial Sloan Kettering Cancer Center 1275 York Avenue in New york and University of Rochester Medical Center in Rochester. Additionally, there are 3 other hospitals providing access to this study."

Answered by AI

Is enrollment for this experiment still open to participants?

"Clinicaltrials.gov indicates that this clinical study is not currently seeking participants, despite being initially posted on June 1st 2014 and most recently updated July 12th 2022. However, these researchers are recruiting for two other trials at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur

2014. "A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02164019.