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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Leeds General Infirmary
Leeds, United Kingdom
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
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