A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/17/2019
Start Date:June 2014
End Date:June 2020
Contact:John Healey, MD
Phone:212-639-7610

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A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of

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.


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
We found this trial at
6
sites
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Phone: 585-275-7087
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Rui Yank, MD
Phone: 718-920-2060
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: William Edward, MD
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Grand Rapids, Michigan 69546
Principal Investigator: Matt Steensma, MD
Phone: 616-486-5961
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Grand Rapids, MI
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New York, New York 10021
Principal Investigator: John Healey, MD
Phone: 212-639-7610
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New York, NY
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750 East Adams Street
Syracuse, New York 13210
Principal Investigator: Timothy Damron, MD
Phone: 315-464-4472
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Syracuse, NY
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