long-stem cemented hemiarthroplasty (LSCH) for Proximal Femoral Metastases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Proximal Femoral Metastases+1 More
questionnaires - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Proximal Femoral Metastases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 1 year

1 year
postoperative complications
12 weeks
differences in postoperative functional outcomes
first two weeks post surgery
differences in transfusion volume

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

long-stem cemented hemiarthroplasty (LSCH)
1 of 2
intramedullary nailing (IMN)
1 of 2

Active Control

73 Total Participants · 2 Treatment Groups

Primary Treatment: long-stem cemented hemiarthroplasty (LSCH) · No Placebo Group · N/A

long-stem cemented hemiarthroplasty (LSCH)ActiveComparator Group · 2 Interventions: questionnaires, long-stem cemented hemiarthroplasty (LSCH) · Intervention Types: Behavioral, Procedure
intramedullary nailing (IMN)ActiveComparator Group · 2 Interventions: questionnaires, intramedullary nailing (IMN) · Intervention Types: Behavioral, Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Walter Reed National Military Medical CenterFED
125 Previous Clinical Trials
36,046 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,823 Previous Clinical Trials
584,411 Total Patients Enrolled
State University of New York - Upstate Medical UniversityOTHER
155 Previous Clinical Trials
24,161 Total Patients Enrolled
Duke UniversityOTHER
2,159 Previous Clinical Trials
3,188,505 Total Patients Enrolled
University of RochesterOTHER
788 Previous Clinical Trials
500,726 Total Patients Enrolled
Medical University of GrazOTHER
439 Previous Clinical Trials
219,885 Total Patients Enrolled
Spectrum Health Medical GroupUNKNOWN
1 Previous Clinical Trials
700 Total Patients Enrolled
Mayo ClinicOTHER
2,896 Previous Clinical Trials
3,699,248 Total Patients Enrolled
Montefiore Medical CenterOTHER
404 Previous Clinical Trials
552,434 Total Patients Enrolled
John Healey, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
1,019 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People who come to see an orthopedist with a very painful and likely broken femur, in the area near the hip, are said to have a pathologic femur fracture
The patient has a diagnosis of metastatic disease in the abdomen and/or bones which is based on clinical and radiographic evidence
A surgeon's estimated survival is more than 1 month.
for PARP inhibitors, regardless of BRCA status PARP inhibitors will be available to all cancer patients, except those with lymphoma, regardless of their BRCA status.
Patients who are about to have a fracture and have been treated with bevacizumab are eligible for surgery as long as there is a 3 week window between their last infusion and surgery.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: November 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.