NCT00864877

Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Inion Oy · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	biodegradable fixation system (Inion OTPS FreedomPlateTM)

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-04-01
• First posted: 2009-03-19
• Last updated: 2009-03-19

Locations

1 site across 1 country: United Kingdom