Status:
COMPLETED
Inion OTPS Biodegradable Fixation System for the Ankle
Lead Sponsor:
Inion Oy
Conditions:
Surgery
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00300989
Start Date
December 1 2005
End Date
May 1 2007
Last Update
October 5 2007
Active Locations (1)
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1
Inion Oy
Tampere, Finland, 33520