Anterior Cruciate Ligament Injury, Ligament Rupture
Conditions
Brief summary
The aim of the study is to show a reduction of a re-rupture rate with an ACL (antero crusader ligament) + ALL (anterolateral ligament) combined technique compared to a classical Kenneth-Jones ACL (antero crusader ligament) reconstruction technique.
Detailed description
The aim is to evaluate the rate of re-rupture and to analyze knee function through scores analysis as International Knee Documentation Committee Subjective Knee (IKDC), Knee injury and osteoarthritis outcome score (KOOS), Lysholm-Tegner, and by objective measurements of laximetry and rotation. This study should include 2 groups of 296 patients with isolated ACL (antero crusader ligament) with clinical rotation : * operated by a conventional patellar tendon technique (first group) * operated by a technique combining a ALL (anterolateral ligament) and ACL plasty for the second group
Interventions
PROCEDUREACL plasty
standard ligamentoplasty by Kenneth Jones
PROCEDUREACL + ALL plasty
standard ligamentoplasty and anterolateral plasty
Sponsors
Ramsay Générale de Santé
Ascopharm Groupe Novasco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Patients with total isolated antero crusader ligament (ACL) rupture who are candidates for surgical reconstruction * Patients between 18 and 35 years old * Patients with weekly sporting activities * Patients with chronic rotatory instability with a positive pivot shift * Patients who have been informed and do not object the research
Exclusion criteria
* Patients with multi-ligament knee involvement * Patients under 18 years old or over 35 years old * Patients with a BMI of under 18.5 or over 30 * Patients with any contraindication to general anaesthesia * Professional sportsmen/women * Patients with congenital malformation or a rheumatic disease * Patients with repeated antero crusader ligament (ACL) rupture * Patients with serious ligament disease in the contralateral knee * Patients who refuse to take part in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ligament re-rupture rate | 3 years | Clinical instability, laximetry, IRM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tegner Lysholm score | Preoperatively, 1 year and 3 years | Specific knee questionnaire : patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). |
| Rolimeter test | pre-operatively, 6 months, 1 year and 3 years | Antero-posterior laximetry |
| International Knee Documentation Committee Subjective Knee (IKDC) clinical score | preoperatively, 1 year and 3 years | International Knee Documentation Committee Subjective Knee allows a subjective assessment including symptoms, activity and knee function; is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100 (no limitation with activities of daily living or sports activities and the absence of symptoms) |
| Knee radiography | preoperatively and 3 years | Development of osteoarthritis signs |
| Knee injury and osteoarthritis outcome score (KOOS) clinical score | preoperative, 1 year and 3 years | Knee injury and osteoarthritis outcome score is a specific knee questionnaire which evaluates : pain, symptoms, knee function in daily life, knee function in sport practice and quality of life. Scale : None (0) Mild Moderate Severe Extreme (4) Each subscale score is calculated independently. Calculate the mean score of the individual items of each subscale and divide by 4. Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems |
| KiRA test | preoperatively, 6 months and 3 years | Rotatory laximetry |
Countries
France
Outcome results
None listed