Clinical trial NCT03740022: ACL Versus ALL + ACL Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Ligament Rupture
Lead sponsor: Ascopharm Groupe Novasco
Sponsor class: OTHER
Collaborators: name: Ramsay Générale de Santé
First posted: 2018-11-14
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Ligament re-rupture rate
timeFrame: 3 years
Secondary outcomes:
measure: International Knee Documentation Committee Subjective Knee (IKDC) clinical score
timeFrame: preoperatively, 1 year and 3 years
measure: Tegner Lysholm score
timeFrame: Preoperatively, 1 year and 3 years
measure: Rolimeter test
timeFrame: pre-operatively, 6 months, 1 year and 3 years
measure: KiRA test
timeFrame: preoperatively, 6 months and 3 years
measure: Knee radiography
timeFrame: preoperatively and 3 years
measure: Knee injury and osteoarthritis outcome score (KOOS) clinical score
timeFrame: preoperative, 1 year and 3 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz - Centre Paul Santy
Study officials:
References:
citation: Sonnery-Cottet B, Pioger C, Vieira TD, Franck F, Kajetanek C, Fayard JM, Thaunat M, Saithna A. Combined ACL and Anterolateral Reconstruction Is Not Associated With a Higher Risk of Adverse Outcomes: Preliminary Results From the SANTI Randomized Controlled Trial. Orthop J Sports Med. 2020 May 1;8(5):2325967120918490. doi: 10.1177/2325967120918490. eCollection 2020 May.