Inion OTPS Biodegradable Fixation System for the Ankle - Full Text View

Sponsored by:	Inion Oy
Information provided by:	Inion Oy
ClinicalTrials.gov Identifier:	NCT00300989

Purpose

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.

Condition	Intervention	Phase
Surgery	Device: Inion OTPS Biodegradable Fixation System	Phase II

MedlinePlus related topics: Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	A Double-Blind,Randomised,Prospective Clinical Investigation to Compare Post-Operative Fracture Healing Using the Inion OTPS Biodegradable Fixation System Versus Conventional Metal Screws and Plates in the Treatment of Ankle Fractures.

Further study details as provided by Inion Oy:

Primary Outcome Measures:

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 Outcome Measures:

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

Enrollment:	43
Study Start Date:	December 2005
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300989

Locations

Finland
Inion Oy
Tampere, Finland, 33520

Sponsors and Collaborators

Inion Oy

Investigators

Principal Investigator:	Ole Brink	Aarhus University Hospital
Principal Investigator:	Terho Kainonen	Turku Universal Central Hospital
Principal Investigator:	Geir Stray Andreassen	Ullevaal University Hospital

More Information

Study ID Numbers:	D93-701 - 002
Study First Received:	March 9, 2006
Last Updated:	October 4, 2007
ClinicalTrials.gov Identifier:	NCT00300989
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Fractures, Bone

ClinicalTrials.gov processed this record on January 15, 2009