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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metallic implant | Active Comparator | fixation of the ankle fracture with metallic implants |
|
| biodegradable implant | Active Comparator | fixation of the ankle fracture with Freedom plate and screws |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fixation of the ankle fracture (Solco ) | Device | fixation with metallic implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| American Orthopaedic Foot and Ankle Society(AOFAS) score | change from baseline(3 months after surgery) | 3 months, 6 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Short Musculoskeletal Functional Assessment(SMFA) scale | change from baseline (3 months after surgery) | 3 months, 6 months, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung Ho Noh, M.D., Ph.D. | National Police Hospital, Korea, Republic of | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Police Hospital | Seoul | 138-708 | South Korea |
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| fixation of the ankle fracture (Freedom) | Device | fixation with biodegradable implant |
|
|
| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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