ALL Ultrasound Predicts the Success of ACL Repair?

Study Overview
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Brief Summary
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This case series evaluates whether patients with an anterior cruciate ligament (ACL) repair have better outcome if the anterolateral ligament (ALL) was repaired or not considering the ultrasound (US) pre-surgical recommendation.

Detailed Description
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In this case series, the surgeon will decide which patient will have ACL only or ACL and ALL surgery on the basis on multiple parameters. All patient will undergo detailed pre-clinical evaluation, including an ultrasonographic evaluation of the integrity of the ALL. Two subgroups will be compared for the primary outcome (International Knee Documentation Committee score at 8 months of follow-up). In subgroup 1, the surgeon will follow the ultrasonographic evaluation of the ALL considering the ALL repair (i.e. : ALL intact on the ultrasound, ACL repair only; ALL broken on ultrasound; ACL and ALL repair). In subgroup 2, the surgeon will not follow the ultrasonographic evaluation of the ALL considering the ALL repair. Secondary outcomes of interest will be evaluated with multivariate regression analysis. Sample size calculation: The chosen parameter of interest for the primary outcome evaluation is a continuous response variable (IKDC score) from two independent subgroups (ultrasonographic evaluation of the ALL followed or not for the surgical repair), considering a ratio of 1:3 between the two subgroups. In a previous study (AJSM Sonnery-Cottet 2017) the response within each subject group was normally distributed with standard deviation 13.1. If the true difference between the group means is the published minimal clinically important difference of 9 (AJSM Nwachukwu 2017), we will need to study 30 experimental subjects and 90 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.9. The Type I error probability associated with this test of this null hypothesis is 0.05.

Official Title
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Does Anterolateral Ligament Ultrasound Influences the Return-to-play After Anterior Cruciate Ligament Rupture? Survival Analysis

Conditions
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Anterior Cruciate Ligament Rupture, Surgery

Intervention / Treatment
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* Procedure: ACL repair without anterolateral repair
* Procedure: ACL repair with anterolateral repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an ACL rupture and pre-surgical ultrasound evaluation Exclusion Criteria: Sedentary patient without sports activities Prior ACL rupture of the same knee Posterior cruciate ligament rupture

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ACL rupture without indication for ALL surgery<br>Patients with an ACL rupture undergoing surgical repair of the ACL only | Procedure: ACL repair without anterolateral repair<br>* Surgical repair of the ACL using semitendinous autograft<br>|
| ACL rupture with indication for ALL surgery<br>Patients with an ACL rupture undergoing surgical repair of the ACL and the ALL | Procedure: ACL repair with anterolateral repair<br>* Surgical repair of the ACL using semitendinous autograft, and surgical repair of the ALL using an allograft (Arthrex, Extra-Articular Augmentation device)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC score | Self-reported IKDC (International Knee Documentation Committee Subjective Knee Form) score, scaled between 0 and 100 (100 = good function) | Month 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC score | Self-reported IKDC (International Knee Documentation Committee Subjective Knee Form) score, scaled between 0 and 100 (100 = good function) | Months 0, 2, 5, 12 | 
| Lysholm score | The Lysholm score is a 100-point scoring system for examining a patient's knee-specific symptoms including mechanical locking, instability, pain, swelling, stair climbing, and squatting, scaled between 0 and 100 (100 = good function) | Months 0, 2, 5, 8, 12 | 
| SANE score | The Single Numeric Assessment Evaluation is a subjective percentage of the knee functionality, scaled between 0% and 100% (100% = good function) | Months 0, 2, 5, 8, 12 | 
| Return-to-play | Timing when return-to-play to full sports activities is possible | Months 5, 8, 12 | 
| Clinical evaluation: reverse pivot shift test | Described as Clunk absent, Clunk present, or Clunk present with shake | Months 0, 2, 5, 8, 12 | 
| Clinical evaluation: anterior drawer test | Described as Hard stop, Soft stop, or Soft stop and increased course | Months 0, 2, 5, 8, 12 | 
| Clinical evaluation: Lachman test | Described as Hard stop, Soft stop, or Soft stop and increased course | Months 0, 2, 5, 8, 12 | 
| Clinical evaluation: thigh circumference 10 cm proximal to the patella | measure in cm | Months 0, 2, 5, 8, 12 | 
| Clinical evaluation: thigh circumference 15 cm proximal to the patella | measure in cm | Months 0, 2, 5, 8, 12 | 
| Clinical evaluation: knee extension | Measured in °. Negative values associated with bad outcome | Months 0, 2, 5, 8, 12 | 
| Isokinetic test: knee extensors concentric strength | Measured in absolute value and comparative value with controlateral limb | Months 5 & 8 | 
| Isokinetic test: knee flexors concentric strength | Measured in absolute value and comparative value with controlateral limb | Months 5 & 8 | 
| Isokinetic test: knee flexors eccentric strength | Measured in absolute value and comparative value with controlateral limb | Months 5 & 8 | 
| Rerupture rate | Patients will be evaluated by phone at 3 years of follow-up. Rerupture of the ACL graft (yes-no) will be recorded. | Year 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cruciate Ligament Rupture, Anterolateral ligament, Ultrasonography