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The purpose of the investigation is to compare post-operative fracture and wound healing using Inion OTPS Biodegradable Fixation System implants versus Conventional metal implants.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inion OTPS Biodegradable Fixation System | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Functional performance will be determined by using Kaikkonen Functional Scale (Kaikkonen et. al. 1994) and Olerud and Molander Ankle Score (Olerud and Molander 1984) at 12 months post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Sequential post-operative radiographs at 12 months post-operatively; Timepoints for returning to work and/or sport; Wound healing; SF-36 Questionnaire; Subjective pain evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ole Brink | Aarhus University Hospital | Principal Investigator |
| Terho Kainonen | Turku Universal Central Hospital | Principal Investigator |
| Geir Stray Andreassen | Ullevaal University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inion Oy | Tampere | 33520 | Finland |
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