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Anterior Cruciate Ligament Rupture (LIGAMYS)

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ligamys technique
standard technique (anatomic reconstruction)
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring Rupture, Anterior Cruciate Ligament (ACL), Laxity knee, Instability knee

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Ligamys technique

standard technique

Arm Description

Ligamys technique (device) or standard technique

Ligamys technique (device) or standard technique

Outcomes

Primary Outcome Measures

Measuring anterior knee laxity with KT 1000 arthrometer

Secondary Outcome Measures

Tegnér scores
Lysholm scores
IKDC score safety

Full Information

First Posted
March 25, 2016
Last Updated
March 14, 2022
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Société Mathys SA for sponsoring Ligamys Device
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1. Study Identification

Unique Protocol Identification Number
NCT02740452
Brief Title
Anterior Cruciate Ligament Rupture
Acronym
LIGAMYS
Official Title
Ligamys Technique Versus Standard Technique for the Anterior Cruciate Ligament Rupture
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Société Mathys SA for sponsoring Ligamys Device

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
Keywords
Rupture, Anterior Cruciate Ligament (ACL), Laxity knee, Instability knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ligamys technique
Arm Type
Other
Arm Description
Ligamys technique (device) or standard technique
Arm Title
standard technique
Arm Type
Other
Arm Description
Ligamys technique (device) or standard technique
Intervention Type
Device
Intervention Name(s)
ligamys technique
Intervention Description
Ligamys technique (device) or standard technique
Intervention Type
Other
Intervention Name(s)
standard technique (anatomic reconstruction)
Intervention Description
Ligamys technique (device) or standard technique
Primary Outcome Measure Information:
Title
Measuring anterior knee laxity with KT 1000 arthrometer
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Tegnér scores
Time Frame
at 12 months
Title
Lysholm scores
Time Frame
at 12 months
Title
IKDC score safety
Time Frame
at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane DESCAMPS
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Stephane DESCAMPS
First Name & Middle Initial & Last Name & Degree
Hervé SILBERT

12. IPD Sharing Statement

Learn more about this trial

Anterior Cruciate Ligament Rupture

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