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Inion OTPS Biodegradable Fixation System for the Ankle

Sponsor
Inion Oy (Industry)
Overall Status
Completed
CT.gov ID
NCT00300989
Collaborator
(none)
43
Enrollment
1
Location
17
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Inion OTPS Biodegradable Fixation System
 Phase 2

Study Design

Study Type:
Interventional
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 :
Dec 1, 2005
Actual Study Completion Date :
May 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00300989
Other Study ID Numbers:
  • D93-701 - 002
First Posted:
Mar 10, 2006
Last Update Posted:
Oct 5, 2007
Last Verified:
Oct 1, 2007

Study Results

No Results Posted as of Oct 5, 2007