Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture
|ClinicalTrials.gov Identifier: NCT00864877|
Recruitment Status : Unknown
Verified March 2009 by Inion Oy.
Recruitment status was: Not yet recruiting
First Posted : March 19, 2009
Last Update Posted : March 19, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Distal Fibular Fracture Bimalleolar Fracture Trimalleolar Fracture||Device: biodegradable fixation system (Inion OTPS FreedomPlateTM)||Not Applicable|
|Study Type :||Interventional (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.|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||April 2012|
Device: biodegradable fixation system (Inion OTPS FreedomPlateTM)
- The functional performance will be primarily determined by the Olerud and Molander Ankle Score [ Time Frame: at 2, 6 and 12 weeks, and 12 and 24 months post-operatively ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864877
|Leeds General Infirmary|
|Leeds, United Kingdom, LS13EX|
|Principal Investigator:||Peter Giannoudis, Professor||Leeds General Infirmary|