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Completed

NCT Number: NCT00300989

Inion OTPS Biodegradable Fixation System for the Ankle

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.

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Key information

Conditions

Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Inion Oy

Tampere, 33520, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inion OTPS Biodegradable Fixation System

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Inion Oy

Industry

Registry information

Official study 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.

Important dates

Study start
2005
Study completion
2007
First posted
Mar 10, 2006
Registry last updated
Oct 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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