Anterior Cruciate Ligament Injury Clinical Trial
Official title:
Assessment of the Results of Combined Anterolateral Ligament (ALL) + Antero Crusader Ligament (ACL) Plasty Compared to Classical KJ Plasty in Isolated ACL Ruptures
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.
Status | Recruiting |
Enrollment | 592 |
Est. completion date | August 2022 |
Est. primary completion date | August 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Privé Jean Mermoz - Centre Paul Santy | Lyon |
Lead Sponsor | Collaborator |
---|---|
Ascopharm Groupe Novasco | Ramsay Générale de Santé |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ligament re-rupture rate | Clinical instability, laximetry, IRM | 3 years | |
Secondary | International Knee Documentation Committee Subjective Knee (IKDC) clinical score | 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) | preoperatively, 1 year and 3 years | |
Secondary | Tegner Lysholm score | 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). | Preoperatively, 1 year and 3 years | |
Secondary | Rolimeter test | Antero-posterior laximetry | pre-operatively, 6 months, 1 year and 3 years | |
Secondary | KiRA test | Rotatory laximetry | preoperatively, 6 months and 3 years | |
Secondary | Knee radiography | Development of osteoarthritis signs | preoperatively and 3 years | |
Secondary | Knee injury and osteoarthritis outcome score (KOOS) clinical score | 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 | preoperative, 1 year and 3 years |
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