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Inion OTPS Biodegradable Fixation System for the Ankle

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ClinicalTrials.gov Identifier: NCT00300989
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : October 5, 2007
Sponsor:
Information provided by:
Inion Oy

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.

Condition or disease Intervention/treatment Phase
Surgery Device: Inion OTPS Biodegradable Fixation System Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : December 2005
Actual Study Completion Date : May 2007



Primary Outcome Measures :
  1. 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 :
  1. 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


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00300989     History of Changes
Other Study ID Numbers: D93-701 - 002
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: October 5, 2007
Last Verified: October 2007