ACL Versus ALL + ACL Study

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Injury; Ligament Rupture
• Intervention / Treatment: Procedure: ACL plasty; Procedure: ACL + ALL plasty

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

• Study Type: Interventional
• Enrollment (Actual): 592
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Hôpital Privé Jean Mermoz - Centre Paul Santy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ACL plasty; The surgical procedure consists of a ligamentoplasty of the antero crusader ligament (ACL) with the patellar tendon according to a conventional arthroscopic procedure.	Procedure: ACL plasty; standard ligamentoplasty by Kenneth Jones
Experimental: ACL + ALL plasty; The surgical procedure consists of a hamstring ligamentoplasty (DIDT) of the antero crusader ligament (ACL) and anterolateral ligament (ALL) according to a published arthroscopic procedure.	Procedure: ACL + ALL plasty; standard ligamentoplasty and anterolateral plasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ligament re-rupture rate	Clinical instability, laximetry, IRM	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Rolimeter test	Antero-posterior laximetry	pre-operatively, 6 months, 1 year and 3 years
KiRA test	Rotatory laximetry	preoperatively, 6 months and 3 years
Knee radiography	Development of osteoarthritis signs	preoperatively and 3 years
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

Collaborators and Investigators

• Sponsor: Ascopharm Groupe Novasco
• Collaborators: Ramsay Générale de Santé

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2016
• Primary Completion (Actual): June 10, 2024
• Study Completion (Actual): June 10, 2024

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Rupture
• Other Study ID Numbers: 2016-A00144-47