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Inion OTPS Biodegradable Fixation System for the Ankle

This study has been completed.
Sponsor:
Information provided by:
Inion Oy
ClinicalTrials.gov Identifier:
NCT00300989
First received: March 9, 2006
Last updated: October 4, 2007
Last verified: October 2007
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

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

No publications provided

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

ClinicalTrials.gov processed this record on May 16, 2013