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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: differences in postoperative functional outcomes [ Time Frame: 12 weeks ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • postoperative complications [ Time Frame: 1 year ]
    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 ]
    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.


Original Secondary Outcome: Same as current

Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: June 12, 2014
Date Started: June 2014
Date Completion:
Last Updated: October 14, 2016
Last Verified: October 2016