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

Hopital de l'Enfant-Jesus

Status: Completed

Conditions: Ankle Syndesmosis Rupture

Treatments: Procedure: Screw fixation - Synthes® / Static Implant; Procedure: TightRope System- Arthrex® / Dynamic Implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01109303

PEJ-446

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

TightRope System

Active Comparator group

Description:

Patients are operated on using the TightRope implant by Arthrex.

Treatment:

Procedure: TightRope System- Arthrex® / Dynamic Implant

Screw fixation implant

Active Comparator group

Description:

Patients are operated on using the rigid four-cortices 3,5 mm screw fixation by Synthes.

Treatment:

Procedure: Screw fixation - Synthes® / Static Implant