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NCT02164019
A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur
Conditions: Proximal Femoral Metastases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 73
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Spectrum Health Medical Group Grand Rapids Michigan
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT02164019). StuddyBuddy aggregates publicly available trial information.