A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for… (NCT02164019) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur
United States73 participantsStarted 2014-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.