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

National Police Hospital109 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

109

Conditions

Ankle Fracture

Interventions

fixation of the ankle fracture (Solco )DEVICE

fixation with metallic implant

fixation of the ankle fracture (Freedom)DEVICE

fixation with biodegradable implant

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

National Police Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

American Orthopaedic Foot and Ankle Society(AOFAS) score

change from baseline(3 months after surgery)

Time frame: 3 months, 6 months, 1 year

Secondary Outcomes

Short Musculoskeletal Functional Assessment(SMFA) scale

change from baseline (3 months after surgery)

Time frame: 3 months, 6 months, 1 year

Data from ClinicalTrials.gov

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