Proximal Femoral Metastases
Conditions
Keywords
Pathologic Fractures, hip replacements, 12-287
Brief 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.
Interventions
PROCEDURElong-stem cemented hemiarthroplasty (LSCH)
PROCEDUREintramedullary nailing (IMN)
BEHAVIORALquestionnaires
Sponsors
Memorial Sloan Kettering Cancer Center
State University of New York - Upstate Medical University
Spectrum Health Medical Group
University of Rochester
Mayo Clinic
Walter Reed National Military Medical Center
Duke University
Montefiore Medical Center
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toronto Extremity Salvage Score (TESS) | 12 weeks post-op | Implant-specific differences in postoperative functional outcomes will be determined throughout the study period using Toronto Extremity Salvage Score (TESS); the primary outcome assessment will take place at the 12-week follow-up visit. |
Secondary
| Measure | Time frame |
|---|---|
| Pain VAS score | 12 weeks post-op |
| Narcotic usage cumulative | 12 weeks post-op |
| Timed get up and go test | 12 weeks post-op |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn Healey, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed