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

Phase 4

Completed

• Conditions: Ankle Fracture
• Interventions: Device: fixation of the ankle fracture (Solco ); Device: fixation of the ankle fracture (Freedom)

• Registration Number: NCT01431560
• Lead Sponsor: National Police Hospital

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 Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2010-01
• Study Completion: 2011-08
• Status Verified: 2011-09
• Study First Submitted: 2011-09-02
• Study First Submitted QC: 2011-09-08
• Last Update Submitted: 2011-09-08
• Study First Posted: 2011-09-09
• Last Update Posted: 2011-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• skeletally mature subjects (≥16 years old) with unilateral ankle fractures

Exclusion Criteria

• subjects less than 16 years old,
• subjects not followed up at this hospital,
• multiple injuries,
• bilateral ankle fractures,
• open fractures,
• pathologic fractures,
• concomitant tibial shaft fractures,
• previous history of immobilization due to significant injury or a fracture of either ankle,
• significant peripheral neuropathy,
• soft tissue infection in the region on either injured ankle,
• or inability to complete the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metallic implant	fixation of the ankle fracture (Solco )	fixation of the ankle fracture with metallic implants
biodegradable implant	fixation of the ankle fracture (Freedom)	fixation of the ankle fracture with Freedom plate and screws

Primary Outcome Measures

Name	Time	Method
American Orthopaedic Foot and Ankle Society(AOFAS) score	3 months, 6 months, 1 year	change from baseline(3 months after surgery)

Secondary Outcome Measures

Name	Time	Method
Short Musculoskeletal Functional Assessment(SMFA) scale	3 months, 6 months, 1 year	change from baseline (3 months after surgery)

Trial Locations

Locations (1)

National Police Hospital; 🇰🇷 Seoul, Korea, Republic of