Anterior Cruciate Ligament Rupture
Conditions
Keywords
Rupture, Anterior Cruciate Ligament (ACL), Laxity knee, Instability knee
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.
Interventions
DEVICEligamys technique
Ligamys technique (device) or standard technique
OTHERstandard technique (anatomic reconstruction)
Ligamys technique (device) or standard technique
Sponsors
Société Mathys SA for sponsoring Ligamys Device
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measuring anterior knee laxity with KT 1000 arthrometer | at 12 months |
Secondary
| Measure | Time frame |
|---|---|
| IKDC score safety | at 12 months |
| Tegnér scores | at 12 months |
| Lysholm scores | at 12 months |
Countries
France
Contacts
Primary ContactPatrick LACARIN
Outcome results
None listed