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

Not Applicable

Completed

• Conditions: Ankle Syndesmosis Rupture
• Interventions: Procedure: TightRope System- Arthrex® / Dynamic Implant; Procedure: Screw fixation - Synthes® / Static Implant

• Registration Number: NCT01109303
• Lead Sponsor: Hopital de l'Enfant-Jesus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-23
• Primary Completion: 2011-02
• Study Completion: 2012-01
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TightRope System	TightRope System- Arthrex® / Dynamic Implant	Patients are operated on using the TightRope implant by Arthrex.
Screw fixation implant	Screw fixation - Synthes® / Static Implant	Patients are operated on using the rigid four-cortices 3,5 mm screw fixation by Synthes.

Primary Outcome Measures

Name	Time	Method
Olerud-Molander score	3 months after surgery	The Olerud-Molander scoring scale was chosen because it adequately represents the ankle performance following surgery (trauma or elective basis). It comprises nine functional parameters which are concerned with primary complaints, the ability to perform simple tasks and the everyday life activities.

Secondary Outcome Measures

Name	Time	Method
Rate of secondary surgery	within one year following surgery	To measure the rate of secondary surgery due to infection or implant removal. Every secondary surgery during the following year counts, even for the same patient.
Radiological loss of reduction	12 months after surgery	Adequate reduction of the syndesmosis is evaluated on a simple X-ray in the AP and mortise views; the "clear space" is the distance between the medial side of fibula and the incisural surface of tibia (1 cm above tibial pilon) and cannot be more than 6 mm.; Rate of loss of reduction and the range of this loss over 6 mm will be calculated in each group.
Implant failure	one year after surgery	Rate of implant failure (with or without a second surgery for removal) will be measured in each group.
American Orthopaedic Foot and Ankle Society (AOFAS) score of hindfoot	12 weeks after surgery	An evaluation of the function (7 criteria), alignment (1 criteria) and pain (1 criteria), for a maximum of 100 points on the AOFAS scale.
AOFAS score of hindfoot	12 months after surgery	An evaluation of the function (7 criteria), alignment (1 criteria) and pain (1 criteria), for a maximum of 100 points on the AOFAS scale.
Return to professional activities	3 months after surgery	This measure will be determined in days after surgery, for rate of 50% and 100% of the usual work load.
Pain on visual analog scale (VAS)	12 weeks after surgery	Pain is described with the VAS, which ranges from 1 to 10.
Pain on VAS	12 months after surgery	Pain is described with the VAS, which ranges from 1 to 10.
Range of motion	12 months after surgery	With a goniometer, a measure of the dorsal flexion (normal value 20°) and plantar flexion (40°) will be taken. Inversion and eversion will be measured according to this scale: + = weak ; ++ = middle ; +++ = complete.
Muscular trophicity measure of the leg	12 months after surgery	This measure is taken with a metric band 15 cm under the inferior patellar pole and must be compared to normal side. It is defined in cm with a precision of 0.5 cm. A ratio injured side/normal side will be calculated.
Ankle circumference measure	12 months after surgery	This measure is taken with a metric band at the bimalleolar level and must be compared to normal side. It is defined in cm with a precision of 0.5 cm. A ratio injured side/normal side will be calculated.

Trial Locations

Locations (1)

CHA-Pavillon Enfant-Jésus; 🇨🇦 Québec, Quebec, Canada