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

National Police Hospital

Status and phase: Completed; Phase 4

Conditions: Ankle Fracture

Treatments: Device: fixation of the ankle fracture (Freedom); Device: fixation of the ankle fracture (Solco )

Study type: Interventional

Funder types: Other

Identifiers

NCT01431560

National Police Hospital

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

metallic implant

Active Comparator group

Description:

fixation of the ankle fracture with metallic implants

Treatment:

Device: fixation of the ankle fracture (Solco )

biodegradable implant

Active Comparator group

Description:

fixation of the ankle fracture with Freedom plate and screws

Treatment:

Device: fixation of the ankle fracture (Freedom)