NCT Number: NCT02164019
A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur
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.
This study is active but is not currently recruiting participants.
Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Spectrum Health Medical Group, Grand Rapids, Michigan, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
intramedullary nailing (IMN)
ProcedureQuestionnaires
BehavioralPrimary outcomes
-
Toronto Extremity Salvage Score (TESS)
Time frame: 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 outcomes
-
Pain VAS score
Time frame: 12 weeks post-op
-
Narcotic usage cumulative
Time frame: 12 weeks post-op
-
Timed get up and go test
Time frame: 12 weeks post-op
Other outcomes
-
Infections
Time frame: 12 weeks post-op
-
Blood loss
Time frame: 12 weeks post-op
Sponsors and collaborators
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Collaborators
- Duke University
- Mayo Clinic
- Medical University of Graz
- Montefiore Medical Center
- Spectrum Health Medical Group
- State University of New York - Upstate Medical University
- University of Rochester
- Walter Reed National Military Medical Center
Registry information
Official study title
A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of
Important dates
- Study start
- 2014
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 16, 2014
- Registry last updated
- Jul 22, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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