Static Implant Versus Dynamic Implant in the Surgical Treatment on Ankle Syndesmosis Rupture

Prospective Randomized Multicentric Trial Comparing a Static Implant and a Dynamic Implant in the Surgical Treatment of Ankle Syndesmosis Rupture

Ankle fracture is frequent and its number is increasing. In Canada, surgical treatment of these lesions is advised and the options currently used all have in common a rigid fixation of the syndesmosis which results in residual stiffness and a high level of secondary surgery, mostly to remove the implant.

The purpose of the study is to compare the treatment of ankle syndesmotic rupture by a dynamic fixation to a static fixation suggesting that the dynamic fixation method will improve the Olerud-Molander functional score of more than 15 points at the 3 months follow-up.

Inclusion Criteria:

• men or women ≥ 18 years-old;
• ankle fracture type 44-C (AO classification) with an AP, lateral and mortise X-ray views of the ankle and an AP and lateral X-ray views of the leg;
• open fractures (Gustilo I-IIIb) or closed;
• trauma-surgery delay of less than 7 days;
• consent form signed.

Exclusion Criteria:

• ankle fractures without syndesmotic lesion;
• fracture associated with neuro-vascular lesions (Gustillo IIIc);
• pathologic fracture;
• fracture in a polytraumatized patient;
• fracture of a bone in the ipsilateral leg;
• men or women > 65 years-old;
• chronic cardiac insufficiency (ejection fraction < 30%);
• lower leg chronic venous insufficiency;
• neuro-arthropathic foot (Charcot, diabetes, etc…);
• body mass index ≥ 40;
• past medical history of fracture of the same ankle;
• medical conditions too serious for a surgery;
• men or women unfit to consent;
• any other conditions that make the examinator thinks that the follow up would be problematic.