Clinical Trial: Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants

Brief Summary: The purposes of this study are to compare the outcomes of the biodegradable implants for the fixation of ankle fracture and those of metallic implants, and to assess the problems of the biodegradable implants. Null hypothesis is that the clinical outcomes of biodegradable plate and screws for ankle fracture are not different from those of metallic implants.

Detailed Summary:
Sponsor: National Police Hospital

Current Primary Outcome: American Orthopaedic Foot and Ankle Society(AOFAS) score [ Time Frame: 3 months, 6 months, 1 year ]

change from baseline(3 months after surgery)


Original Primary Outcome: Same as current

Current Secondary Outcome: Short Musculoskeletal Functional Assessment(SMFA) scale [ Time Frame: 3 months, 6 months, 1 year ]

change from baseline (3 months after surgery)


Original Secondary Outcome: Same as current

Information By: National Police Hospital

Dates:
Date Received: September 2, 2011
Date Started: June 2008
Date Completion:
Last Updated: September 8, 2011
Last Verified: September 2011