Surgery
Conditions
Brief summary
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.
Interventions
DEVICEInion OTPS Biodegradable Fixation System
Sponsors
Inion Oy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Distal fibular fracture including either instabile/dislocated Weber class B or any Weber class C fracture OR bimalloelar fracture with lateral malloelus fracture and medial malleolus fracture OR trimalleolar fracture with lateral and medial malleolus fractures and posterior malleolus fracture with less than 1/4 of the articulas surface fractured * Fresh/acute fracture * Aged between 18 and 60 years
Exclusion criteria
* Contraindication for the Inion OTPS Biodegradable Fixation System:Active or potential infection,patient's conditions, limited blood supply, insufficient quantity or quality of bone,where patient cooperation can not be quaranteed * Multiple trauma * Previous ankle fracture * Pregnancy * Bone malignancy * Any clinically significant condition based on investigators judgement * high-load bearing applications
Design outcomes
Primary
| Measure | 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. | — |
Secondary
| Measure | 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 | — |
Countries
Finland
Outcome results
None listed