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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
State University of New York - Upstate Medical University
Spectrum Health Medical Group
University of Rochester
Mayo Clinic
Mayo Clinic, Jacksonville, FL
Walter Reed National Military Medical Center
Duke University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02164019
First received: June 12, 2014
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Proximal Femoral Metastases
Procedure: long-stem cemented hemiarthroplasty (LSCH)
Procedure: intramedullary nailing (IMN)
Behavioral: questionnaires

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • differences in postoperative functional outcomes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • postoperative complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Complications will be summarized by type (e.g., superficial infection, deep infection, dislocation, etc), and complication rates will be compared between groups using Fisher's Exact test.

  • differences in transfusion volume [ Time Frame: first two weeks post surgery ] [ Designated as safety issue: No ]
    The number of units of transfused blood during the first two weeks post surgery will be summarized and compared between groups using the Wilcoxon rank sum test.


Estimated Enrollment: 114
Study Start Date: June 2014
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: long-stem cemented hemiarthroplasty (LSCH)
(LSCH), "Hip, Ball, Rod and Cement" Replace the ball of the hip joint with a metal ball and a rod that is placed inside the thigh bone with cement to keep the implant in place. The study participation period for each patient is 360 days from the date of surgery and includes 5 defined timepoints that include the suture removal visit at 3 weeks and follow-up clinical visits for radiographs and rehabilitation progress checks at 6 weeks, 12 weeks, 6 months, and 12 months after surgery. At each follow-up visit, a combination of questionnaires and physical tests will be administered to assess physical function, general health status, disability level, and pain control.
Procedure: long-stem cemented hemiarthroplasty (LSCH) Behavioral: questionnaires
Active Comparator: intramedullary nailing (IMN)
Intramedullary nailing (IMN), "Rod and Screws" A metal rod is placed inside your thigh bone and secured in place by metal screws just below the hip and above the knee. The study participation period for each patient is 360 days from the date of surgery and includes 5 defined timepoints that include the suture removal visit at 3 weeks and follow-up clinical visits for radiographs and rehabilitation progress checks at 6 weeks, 12 weeks, 6 months, and 12 months after surgery. At each follow-up visit, a combination of questionnaires and physical tests will be administered to assess physical function, general health status, disability level, and pain control.
Procedure: intramedullary nailing (IMN) Behavioral: questionnaires

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • Previous pathologic confirmation of original cancer diagnosis (pathology report is sufficient) and a 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02164019

Contacts
Contact: John Healey, MD 212-639-7610
Contact: Patrick Boland, MD 212-639-8684

Locations
United States, New York
Memorial Sloan Kettering Cancer Center 1275 York Avenue Recruiting
New York, New York, United States, 10065
Contact: John Healey, MD    212-639-7611      
Contact: Patrick Boland, MD    212-639-8684      
Principal Investigator: John Healey, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
State University of New York - Upstate Medical University
Spectrum Health Medical Group
University of Rochester
Mayo Clinic
Mayo Clinic, Jacksonville, FL
Walter Reed National Military Medical Center
Duke University
Investigators
Principal Investigator: John Healey, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02164019     History of Changes
Other Study ID Numbers: 12-287
Study First Received: June 12, 2014
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Pathologic Fractures
hip replacements
12-287

Additional relevant MeSH terms:
Fractures, Spontaneous
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014