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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1J 1Z4
      • CHA-Pavillon Enfant-Jésus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TightRope System; Patients are operated on using the TightRope implant by Arthrex.	Procedure: TightRope System- Arthrex® / Dynamic Implant; Patients are operated on using a dynamic implant, the TightRope System by Arthrex®. The ankle is immobilized in a plaster boot for 6 weeks.
Active Comparator: Screw fixation implant; Patients are operated on using the rigid four-cortices 3,5 mm screw fixation by Synthes.	Procedure: Screw fixation - Synthes® / Static Implant; Patients are operated on using a static implant, the rigid four-cortices 3,5 mm screw fixation by Synthes®. The ankle is immobilized in a plaster boot for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Olerud-Molander score	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.	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of secondary 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.	within one year following surgery
Radiological loss of reduction	Adequate reduction of the syndesmosis is evaluated on a simple X-ray in the anteroposterior (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.	2 weeks after surgery
Implant failure	Rate of implant failure (with or without a second surgery for removal) will be measured in each group.	one year after surgery
Radiological loss of reduction	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.	6 weeks after surgery
Radiological loss of reduction	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.	12 weeks after surgery
Radiological loss of reduction	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.	6 months after surgery
Radiological loss of reduction	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.	12 months after surgery
American Orthopaedic Foot and Ankle Society (AOFAS) score of hindfoot	An evaluation of the function (7 criteria), alignment (1 criteria) and pain (1 criteria), for a maximum of 100 points on the AOFAS scale.	12 weeks after surgery
AOFAS score of hindfoot	An evaluation of the function (7 criteria), alignment (1 criteria) and pain (1 criteria), for a maximum of 100 points on the AOFAS scale.	6 months after surgery
AOFAS score of hindfoot	An evaluation of the function (7 criteria), alignment (1 criteria) and pain (1 criteria), for a maximum of 100 points on the AOFAS scale.	12 months after surgery
Return to professional activities	This measure will be determined in days after surgery, for rate of 50% and 100% of the usual work load.	3 months after surgery
Pain on visual analog scale (VAS)	Pain is described with the VAS, which ranges from 1 to 10.	12 weeks after surgery
Pain on VAS	Pain is described with the VAS, which ranges from 1 to 10.	12 weeks after surgery
Pain on VAS	Pain is described with the VAS, which ranges from 1 to 10.	12 months after surgery
Range of motion	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.	12 weeks after surgery
Range of motion	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.	6 months after surgery
Range of motion	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.	12 months after surgery
Muscular trophicity measure of the leg	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.	12 weeks after surgery
Muscular trophicity measure of the leg	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.	6 months after surgery
Muscular trophicity measure of the leg	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.	12 months after surgery
Ankle circumference measure	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.	12 weeks after surgery
Ankle circumference measure	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.	6 months after surgery
Ankle circumference measure	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.	12 months after surgery

Collaborators and Investigators

• Sponsor: Hopital de l'Enfant-Jesus
• Collaborators: Arthrex, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 21, 2010
• First Posted (Estimate): April 23, 2010

Study Record Updates

• Last Update Posted (Estimate): December 20, 2012
• Last Update Submitted That Met QC Criteria: December 19, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: ankle fracture with syndesmotic ligament rupture; ankle syndesmosis rupture
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: PEJ-446