Inion OTPS Biodegradable Fixation System for the Ankle

Inion

Status and phase

Completed

Phase 2

Conditions

Surgery

Treatments

Device: Inion OTPS Biodegradable Fixation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00300989

D93-701 - 002

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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