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.
Brief Title
A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur
Completion Date
Completion Date Type
Estimated
Conditions
Proximal Femoral Metastases
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Pathologic Fractures
hip replacements
12-287
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02164019
Org Class
Other
Org Full Name
Memorial Sloan Kettering Cancer Center
Org Study Id
12-287
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of
Primary Outcomes
Outcome Description
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.
Outcome Measure
differences in postoperative functional outcomes
Outcome Time Frame
12 weeks
Secondary Outcomes
Outcome Description
Complications will be summarized by type (e.g., superficial infection, deep infection, dislocation, etc), and complication rates will be compared between groups using Fisher's Exact test.
Outcome Time Frame
1 year
Outcome Measure
postoperative complications
Outcome Description
The number of units of transfused blood during the first two weeks post surgery will be summarized and compared between groups using the Wilcoxon rank sum test.
Outcome Time Frame
first two weeks post surgery
Outcome Measure
differences in transfusion volume
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rui Yang
Investigator Email
ryan@montefiore.org
Investigator Phone
ryan
MeSH Terms
FRACTURES, SPONTANEOUS
FRACTURES, BONE
WOUNDS AND INJURIES
FRACTURE FIXATION, INTRAMEDULLARY
SURVEYS AND QUESTIONNAIRES
FRACTURE FIXATION, INTERNAL
FRACTURE FIXATION
ORTHOPEDIC PROCEDURES
THERAPEUTICS
SURGICAL PROCEDURES, OPERATIVE
DATA COLLECTION
EPIDEMIOLOGIC METHODS
INVESTIGATIVE TECHNIQUES
HEALTH CARE EVALUATION MECHANISMS
QUALITY OF HEALTH CARE
HEALTH CARE QUALITY, ACCESS, AND EVALUATION
PUBLIC HEALTH
ENVIRONMENT AND PUBLIC HEALTH