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 ]

Determined via radiographic analysis


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