A Study of Patient Quality of Life and Function after Alternative Surgeries for Pathologic Fractures of the Femur
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-000857
- Jacksonville, Florida: 15-000857
NCT ID: NCT02164019
Sponsor Protocol Number: 12-287
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Surgeon's estimated survival ≥ 1 month
- 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
- An impending fracture and has had bevacizumab if there will be a 3-week window between the last infusion and surgery
- Diagnosis of widespread visceral and/or osseous metastatic disease based on clinical and radiographic evidence (may continue on study if surgery shows a non-malignant process)
- All cancer diagnoses, except lymphoma
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 (if 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
- Advanced hip arthritis on radiographic imaging
- Previous randomization for a contralateral procedure as part of this study
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Peter Rose, M.D. |
Closed for enrollment |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Courtney Sherman, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available