Back to resultsA Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur
Primary Purpose
Proximal Femoral Metastases
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
long-stem cemented hemiarthroplasty (LSCH)
intramedullary nailing (IMN)
questionnaires
Sponsored by
About this trial
This is an interventional treatment trial for Proximal Femoral Metastases focused on measuring Pathologic Fractures, hip replacements, 12-287
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
Sites / Locations
- Spectrum Health Medical Group
- Montefiore Medical Center
- Memorial Sloan Kettering Cancer Center 1275 York Avenue
- University of Rochester Medical Center
- SUNY Upstate Medical University
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
long-stem cemented hemiarthroplasty (LSCH)
intramedullary nailing (IMN)
Arm Description
(LSCH), "Hip, Ball, Rod and Cement" Replace the ball of the hip joint with a metal ball and a rod that is placed inside the thigh bone with cement to keep the implant in place. The study participation period for each patient is 360 days from the date of surgery and includes 5 defined timepoints that include the suture removal visit at 3 weeks and follow-up clinical visits for radiographs and rehabilitation progress checks at 6 weeks, 12 weeks, 6 months, and 12 months after surgery. At each follow-up visit, a combination of questionnaires and physical tests will be administered to assess physical function, general health status, disability level, and pain control. Some patients may be in a rehabilitation center or on hospice care and will miss their follow-up appointments. To collect data for the primary endpoint, the 6 week and/or 12 week TESS can be done over phone if necessary.
Intramedullary nailing (IMN), "Rod and Screws" A metal rod is placed inside your thigh bone and secured in place by metal screws just below the hip and above the knee. The study participation period for each patient is 360 days from the date of surgery and includes 5 defined timepoints that include the suture removal visit at 3 weeks and follow-up clinical visits for radiographs and rehabilitation progress checks at 6 weeks, 12 weeks, 6 months, and 12 months after surgery. At each follow-up visit, a combination of questionnaires and physical tests will be administered to assess physical function, general health status, disability level, and pain control. Some patients may be in a rehabilitation center or on hospice care and will miss their follow-up appointments. To collect data for the primary endpoint, the 6 week and/or 12 week TESS can be done over phone if necessary.
Outcomes
Primary Outcome Measures
differences in postoperative functional outcomes
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 Outcome Measures
postoperative complications
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.
differences in transfusion volume
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.
Full Information
NCT ID
NCT02164019
First Posted
June 12, 2014
Last Updated
July 12, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT02164019
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2014 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
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
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Femoral Metastases
Keywords
Pathologic Fractures, hip replacements, 12-287
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
long-stem cemented hemiarthroplasty (LSCH)
Arm Type
Active Comparator
Arm Description
(LSCH), "Hip, Ball, Rod and Cement" Replace the ball of the hip joint with a metal ball and a rod that is placed inside the thigh bone with cement to keep the implant in place. The study participation period for each patient is 360 days from the date of surgery and includes 5 defined timepoints that include the suture removal visit at 3 weeks and follow-up clinical visits for radiographs and rehabilitation progress checks at 6 weeks, 12 weeks, 6 months, and 12 months after surgery. At each follow-up visit, a combination of questionnaires and physical tests will be administered to assess physical function, general health status, disability level, and pain control. Some patients may be in a rehabilitation center or on hospice care and will miss their follow-up appointments. To collect data for the primary endpoint, the 6 week and/or 12 week TESS can be done over phone if necessary.
Arm Title
intramedullary nailing (IMN)
Arm Type
Active Comparator
Arm Description
Intramedullary nailing (IMN), "Rod and Screws" A metal rod is placed inside your thigh bone and secured in place by metal screws just below the hip and above the knee. The study participation period for each patient is 360 days from the date of surgery and includes 5 defined timepoints that include the suture removal visit at 3 weeks and follow-up clinical visits for radiographs and rehabilitation progress checks at 6 weeks, 12 weeks, 6 months, and 12 months after surgery. At each follow-up visit, a combination of questionnaires and physical tests will be administered to assess physical function, general health status, disability level, and pain control. Some patients may be in a rehabilitation center or on hospice care and will miss their follow-up appointments. To collect data for the primary endpoint, the 6 week and/or 12 week TESS can be done over phone if necessary.
Intervention Type
Procedure
Intervention Name(s)
long-stem cemented hemiarthroplasty (LSCH)
Intervention Type
Procedure
Intervention Name(s)
intramedullary nailing (IMN)
Intervention Type
Behavioral
Intervention Name(s)
questionnaires
Primary Outcome Measure Information:
Title
differences in postoperative functional outcomes
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
postoperative complications
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.
Time Frame
1 year
Title
differences in transfusion volume
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.
Time Frame
first two weeks post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Healey, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health Medical Group
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center 1275 York Avenue
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur
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