Anterior Cruciate Ligament Rupture (LIGAMYS)

March 14, 2022 updated by: University Hospital, Clermont-Ferrand

Ligamys Technique Versus Standard Technique for the Anterior Cruciate Ligament Rupture

The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical technique versus standard technique.

The aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The treatment of acute ruptures of the anterior cruciate ligament is surgical in some cases with ligamentoplasty technique.

Contrary to the classic ligamentoplasty, the treatment with Ligamys consists of promoting heating of the ligament itself by controlling mechanical environment.

It allows a "dynamic" stabilization of the torn Anterior Cruciate Ligament with in the 3 weekly following traumatism. These techniques may improve the recovery process, proprioceptive results, decrease morbidity of transplant harvesting and faster for the patients. It's all these issues we would like to assess with a randomised multicenter study.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand
        • Principal Investigator:
          • Stephane DESCAMPS
        • Sub-Investigator:
          • Hervé SILBERT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 to 35 years
  • Primary Anterior Cruciate Ligament rupture
  • signed patient consent
  • surgery 21 days or less after traumatism for Ligamys technique

Exclusion Criteria:

  • infection of the operating site
  • previous osseous disease
  • pregnant or nursing woman.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ligamys technique
Ligamys technique (device) or standard technique
Device: ligamys technique
Ligamys technique (device) or standard technique
Other: standard technique
Ligamys technique (device) or standard technique
Other: standard technique (anatomic reconstruction)
Ligamys technique (device) or standard technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measuring anterior knee laxity with KT 1000 arthrometer
Time Frame: at 12 months
at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Tegnér scores
Time Frame: at 12 months
at 12 months
Lysholm scores
Time Frame: at 12 months
at 12 months
IKDC score safety
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Société Mathys SA for sponsoring Ligamys Device

Investigators

  • Principal Investigator: Stephane DESCAMPS, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 25, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU 0260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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