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Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture

NCT00864877 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2009-03-19

No results posted yet for this study

Summary

A randomised, prospective clinical investigation to compare post-operative fracture healing and complication rate after the fixation of ankle fractures using the Inion OTPS FreedomPlateTM Biodegradable Fixation System versus conventional stainless steel metal screws and plates.

The objectives of the investigation are

* to compare post-operative fracture healing (union rates, time-to-union), and the complication rates (hardware failure, infection) between the two Plating Systems (biodegradable INION OTPS FreedomPlateTM vs. Stainless Steel 3.5 Reconstruction or DCP plate, or 1/3 Semitubular plates) at the clinical setting of Ankle fractures
* to study the safety of the clinical application of the biodegradable plating system of Inion OTPS FreedomPlateTM at the acute Ankle fracture setting.

Conditions

  • Distal Fibular Fracture
  • Bimalleolar Fracture
  • Trimalleolar Fracture

Interventions

DEVICE

biodegradable fixation system (Inion OTPS FreedomPlateTM)

Sponsors & Collaborators

  • Inion Oy

    lead INDUSTRY

Principal Investigators

  • Peter Giannoudis, Professor · Leeds General Infirmary

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00864877 on ClinicalTrials.gov