Osteosynthesis of Fibula Fractures With a Locked Thin Plate

Condition(s) studied

Study summary

Ankle fractures represent about 10% of all fractures and are common in both elderly patients with comorbidities and younger polytraumatized individuals. Traditional fibular osteosynthesis uses open plating, which carries up to a 20% complication rate, mainly due to skin issues. These complications are more frequent in patients with diabetes, vascular or neurological disease, obesity, or tobacco/alcohol use, as well as in open fractures or fracture-dislocations. Standard plates can also cause long-term discomfort due to their thickness, often requiring removal.

Recent meta-analyses show that fibular nailing and thin one-third tubular plates result in fewer complications than anatomical plates, while maintaining similar bone-healing rates (97-100%). New thinner locked plates (2.8 mm) have been developed to reduce skin risks and discomfort; biomechanical studies suggest superior strength. Clinical research is needed to confirm their effectiveness and tolerance.

Eligibility

Primary outcome measure(s)

• Evaluate the clinical of patients treated for fixation of an external malleolus fracture, whether isolated or associated with a bi malleolar, tri malleolar, or tibial pilon injury, using a low profile anatomical plate. — 1 year
  Achieving consolidation without skin complications and without the need for hardware removal. * Consolidation is defined as the absence of visible fractures on standard anteroposterior and lateral ankle X-rays at 6 months post-operation. * The absence of skin complications is defined as wound healing achieved within the expected theoretical healing period (1 month). * The absence of a need for hardware removal is defined as the lack of necessity, one year after surgery, for the patient to have the hardware removed due to discomfort caused by the implant.
• Evaluate radiological outcomes of patients treated for fixation of an external malleolus fracture, whether isolated or associated with a bi malleolar, tri malleolar, or tibial pilon injury, using a low profile anatomical plate. — 1 year
  Achieving consolidation without skin complications and without the need for hardware removal. * Consolidation is defined as the absence of visible fractures on standard anteroposterior and lateral ankle X-rays at 6 months post-operation. * The absence of skin complications is defined as wound healing achieved within the expected theoretical healing period (1 month). * The absence of a need for hardware removal is defined as the lack of necessity, one year after surgery, for the patient to have the hardware removed due to discomfort caused by the implant.

Trial sites (1)

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