A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur
1 other identifier
interventional
73
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 12, 2014
CompletedFirst Posted
Study publicly available on registry
June 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedFebruary 27, 2026
February 1, 2026
12 years
June 12, 2014
February 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Toronto Extremity Salvage Score (TESS)
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.
12 weeks post-op
Secondary Outcomes (3)
Pain VAS score
12 weeks post-op
Narcotic usage cumulative
12 weeks post-op
Timed get up and go test
12 weeks post-op
Other Outcomes (2)
Infections
12 weeks post-op
Blood loss
12 weeks post-op
Study Arms (2)
long-stem cemented hemiarthroplasty (LSCH)
ACTIVE COMPARATOR(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)
ACTIVE COMPARATORIntramedullary 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Spectrum Health Medical Groupcollaborator
- State University of New York - Upstate Medical Universitycollaborator
- University of Rochestercollaborator
- Mayo Cliniccollaborator
- Walter Reed National Military Medical Centercollaborator
- Duke Universitycollaborator
- Montefiore Medical Centercollaborator
- Medical University of Grazcollaborator
Study Sites (6)
Spectrum Health Medical Group
Grand Rapids, Michigan, 49503, United States
Memorial Sloan Kettering Cancer Center 1275 York Avenue
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University
Durham, North Carolina, 27708, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Healey, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2014
First Posted
June 16, 2014
Study Start
June 1, 2014
Primary Completion
June 1, 2026
Study Completion
June 1, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02