Clinical trial NCT02164019: A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur
Official title: A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Proximal Femoral Metastases
Keywords: Pathologic Fractures
hip replacements
12-287
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: State University of New York - Upstate Medical University
name: Spectrum Health Medical Group
name: University of Rochester
name: Mayo Clinic
name: Walter Reed National Military Medical Center
name: Duke University
name: Montefiore Medical Center
name: Medical University of Graz
First posted: 2014-06-16
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 \<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

Primary outcomes:
measure: differences in postoperative functional outcomes
timeFrame: 12 weeks
Secondary outcomes:
measure: postoperative complications
timeFrame: 1 year
measure: differences in transfusion volume
timeFrame: first two weeks post surgery
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center 1275 York Avenue
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: John Healey, MD
role: PRINCIPAL_INVESTIGATOR
References: