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

NCT01109303 | Completed

• 1 other identifier: PEJ-446
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Syndesmosis Rupture

Keywords

ankle fracture with syndesmotic ligament rupture; ankle syndesmosis rupture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Rate of secondary surgery

  within one year following surgery

• Radiological loss of reduction

  2 weeks after surgery

• Implant failure

  one year after surgery

• Radiological loss of reduction

  6 weeks after surgery

• Radiological loss of reduction

  12 weeks after surgery

Study Arms (2)

TightRope System

ACTIVE COMPARATOR

Patients are operated on using the TightRope implant by Arthrex.

Procedure: TightRope System- Arthrex® / Dynamic Implant

Screw fixation implant

ACTIVE COMPARATOR

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

Procedure: Screw fixation - Synthes® / Static Implant

Interventions

TightRope System- Arthrex® / Dynamic Implant PROCEDURE

Patients are operated on using a dynamic implant, the TightRope System by Arthrex®. The ankle is immobilized in a plaster boot for 6 weeks.

TightRope System

Screw fixation - Synthes® / Static Implant PROCEDURE

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.

Screw fixation implant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital de l'Enfant-Jesus: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

CHA-Pavillon Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

Location

Study Officials

• Stéphane Pelet, MD, PhD

  Hôpital Enfant-Jésus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Stephane Pelet MD, PhD Orthopedic surgeon

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 23, 2010
• Study Start: October 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: January 1, 2012
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

CA (1)