Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture

Trimalleolar Fracture Clinical Trial

Official title:
A Randomised, Prospective Clinical Investigation to Compare Post-Operative Fracture Healing and Complication Rate After the Fixation of Ankle Fractures Using the Inion OTPS FreedomPlate Biodegradable Fixation System Versus Conventional Metal Screws and Plates.

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00864877
Study type	Interventional
Source	Inion Oy
Contact
Status	Not yet recruiting
Phase	N/A
Start date	May 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02599285` - Fixation of the Posterior Malleolus in Trimalleolar AO Weber C Fractures.	N/A
Recruiting	`NCT02596529` - Fixation of the Posterior Malleolus in Medium-sized Trimalleolar AO Weber-B Fractures.	N/A
Active, not recruiting	`NCT02032966` - Surgical Versus Nonsurgical Treatment of Fibular Fractures: A Prospective Randomized Study	N/A