Inion OTPS Biodegradable Fixation System for the Ankle

Inion Oy43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Surgery

Interventions

Inion OTPS Biodegradable Fixation SystemDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Inion Oy

Tampere, Finland

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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