Clinical Trial: Evaluation of the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
Brief Summary: The purpose of this study is to determine whether the rate of fracture healing and fracture union, repaired with the LISS device, will be as good as or better than the usual fracture fixation systems.
Detailed Summary:
Sponsor: Nova Scotia Health Authority
Current Primary Outcome: Delayed union or nonunion of the distal femur [ Time Frame: 12 months post operative ]
Original Primary Outcome: Delayed union or nonunion of the distal femur
Current Secondary Outcome:
- Time to clinical healing [ Time Frame: 12 months ]assessed by weight-bearing ability and pain
- Function as assessed by patient [ Time Frame: 6 months, 12 months ]Assessed using LEM, SMFA, and SF-36 questionnaires
- Frequency of adverse events [ Time Frame: 12 months ]
- Range of motion [ Time Frame: Post-op, 6 weeks, 3 months, 6 months, 12 months ]
- Gait analysis [ Time Frame: 12 months ]
Original Secondary Outcome:
- Time to clinical healing
- Function as assessed by patient
- Frequency of adverse events
- Range of motion
- Gait analysis
Information By: Nova Scotia Health Authority
Dates:
Date Received: October 30, 2007
Date Started: March 2003
Date Completion:
Last Updated: June 27, 2011
Last Verified: May 2009