Ankle Fracture
Conditions
Keywords
ankle, metallic, biodegradable, Freedom
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.
Interventions
DEVICEfixation of the ankle fracture (Solco )
fixation with metallic implant
DEVICEfixation of the ankle fracture (Freedom)
fixation with biodegradable implant
Sponsors
National Police Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Orthopaedic Foot and Ankle Society(AOFAS) score | 3 months, 6 months, 1 year | change from baseline(3 months after surgery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Musculoskeletal Functional Assessment(SMFA) scale | 3 months, 6 months, 1 year | change from baseline (3 months after surgery) |
Countries
South Korea
Outcome results
None listed