A Study of Patient Quality of Life and Function after Alternative Surgeries for Pathologic Fractures of the Femur

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Peter Rose, M.D.

Cerrado para la inscripción

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Courtney Sherman, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20493025

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