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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014