Clinical Trial: Comparative Study of Fixation or Fusion of Calcaneal Fractures
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective Randomized Multicentre Clinical Trial Comparing Open Reduction Internal Fixation With Primary Subtalar Fusion in Patients With Severely Comminuted (Sanders I
Brief Summary: A multicentre randomized controlled trial that will be conducted at Level 1 trauma centres across Canada. It will compare patients who receive open reduction, internal fixation for Sanders IV calcaneal fractures to patients who receive primary subtalar fusion for the same type of fracture. Patients will be followed up for a period of two years from the time of operation with evaluations being performed at 5 time points: 6 weeks, 3 months, 6 months, 12 months, and 24 months.
Detailed Summary:
Sponsor: University of Calgary
Current Primary Outcome: General Health Survey - SF-36 [ Time Frame: 6 months, 12 months, and 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Validated Visual Analogue Scale [ Time Frame: 6 months, 12 months, and 24 months ]
- Musculoskeletal Function Assessment [ Time Frame: 6 months, 12 months, and 24 months ]
Original Secondary Outcome: Same as current
Information By: University of Calgary
Dates:
Date Received: May 14, 2008
Date Started: February 2004
Date Completion:
Last Updated: February 10, 2015
Last Verified: February 2015
