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Inion OTPS Biodegradable Fixation System for the Ankle

NCT ID: NCT00300989

Last Updated: 2007-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Inion OTPS Biodegradable Fixation System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inion Oy

INDUSTRY

Sponsor Role lead

Principal Investigators

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Ole Brink

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Terho Kainonen

Role: PRINCIPAL_INVESTIGATOR

Turku Universal Central Hospital

Geir Stray Andreassen

Role: PRINCIPAL_INVESTIGATOR

Ullevaal University Hospital

Locations

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Inion Oy

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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D93-701 - 002

Identifier Type: -

Identifier Source: org_study_id