MedDataX Logo

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

NCT ID: NCT01109303

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ankle Syndesmosis Rupture

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ankle fracture with syndesmotic ligament rupture ankle syndesmosis rupture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TightRope System

Patients are operated on using the TightRope implant by Arthrex.

Group Type ACTIVE_COMPARATOR

TightRope System- Arthrex® / Dynamic Implant

Intervention Type 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.

Screw fixation implant

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

Group Type ACTIVE_COMPARATOR

Screw fixation - Synthes® / Static Implant

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Arthrex, Inc.

INDUSTRY

Sponsor Role collaborator

Hopital de l'Enfant-Jesus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pelet Stephane

Dr Stephane Pelet MD, PhD Orthopedic surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stéphane Pelet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Enfant-Jésus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHA-Pavillon Enfant-Jésus

Québec, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PEJ-446

Identifier Type: -

Identifier Source: org_study_id