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A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur | Clinical Trials | Clareo Health

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

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

NCT02164019•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Surgeon's estimated survival ≥ 1 month
•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.
•Patients with an impending fracture who have had bevacizumab are eligible provided there will be a 3-week window between their last infusion and surgery.
•Diagnosis of widespread visceral and/or osseous metastatic disease based on clinical and radiographic evidence. (Patients may continue on study if surgery shows a non-malignant process.)
•All cancer diagnoses, except lymphoma, will be eligible

Exclusion Criteria

•Estimated survival \<1 month
•A large soft tissue mass or other disease involving an area outside of the defined pertrochanteric anatomic region described above. (Patients excluded based on intraoperative findings will be replaced on the study.)
•Prior surgical treatment of the area (i.e., revision cases). A biopsy does not constitute prior surgical treatment.
•Radiographic evidence of an intramedullary occlusion by blastic metastases that would necessitate an alternative method of treatment, such as a plate/screw construct.
•Diagnosis of lymphoma
•Age \< 18 years
•Patients with advanced hip arthritis on radiographic imaging
•Previous randomization for a contralateral procedure as part of this study

Locations (6)

Spectrum Health Medical Group

Grand Rapids, Michigan, United States

Memorial Sloan Kettering Cancer Center 1275 York Avenue

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke University

Durham, North Carolina, United States

Key Dates

Start Date

June 1, 2014

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

February 27, 2026

Enrollment

ACTUAL participants

Conditions

Proximal Femoral Metastases

Interventions

long-stem cemented hemiarthroplasty (LSCH)

PROCEDURE

intramedullary nailing (IMN)

PROCEDURE

questionnaires

BEHAVIORAL