ACL Reconstruction With/Without ALL Reconstruction

Study Overview
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Brief Summary
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This study will compare Anterior Cruciate Reconstruction with or without Anterolateral Ligament Reconstruction in patients with ACL injury. The purpose of this study is evaluate if addition of ALLr to ACLr provides better clinical, radiological and laboratory outcomes.

Detailed Description
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This study compare ACL reconstruction and additional tenodesis or ALL recontruction described by Arnold. Patients will be randomized fot this tree group and surgeon will be blinded. Anterolateral ligament reconstruction could play a role in augmenting rotational stability in the ACL-reconstructed knee and are most likely to benefit hyperlax patients, revision cases, pivoting athletes, and those with IKDC grade III pivot shifts. In our study we will would like to confirm this hypothesis.

Official Title
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Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Anterior Cruciate Ligament Reconstruction With or Without Concomitant AnteroLateral Ligament Reconstruction.

Conditions
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ALL, ACL Injury

Intervention / Treatment
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* Procedure: ACL reconstruction
* Other: ALL anatomic
* Other: ALL tenodesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - primary ACL injury Exclusion Criteria: no informed consent to participate in the study age under 18 years or above 65 multilligament injury or single plane knee instability (medial, lateral) another musculoskeletal disorders in lower limb lower limb deformity requiring axis correction below 4o or above 12.5o joints inflammatory diseases ASA score > II

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: ACL<br>Anterior cruciate ligament reconstruction without additional procedure | Procedure: ACL reconstruction<br>* Anterior cruciate ligament reconstruction<br>|
| Active Comparator: ACL + ALL anatomic<br>Anterior cruciate ligament reconstruction and anatomic anterolateral ligament reconstruction | Procedure: ACL reconstruction<br>* Anterior cruciate ligament reconstruction<br>Other: ALL anatomic<br>* anatomic anterolateral ligament reconstruction<br>|
| Active Comparator: ACL + ALL tenodesis<br>Anterior cruciate ligament reconstruction and anterolateral ligament tenodesis | Procedure: ACL reconstruction<br>* Anterior cruciate ligament reconstruction<br>Other: ALL tenodesis<br>* anterolateral ligament teondesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee stability | KT-1000 assesment for knee stability | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional tests | hop-for-distance | 12 months | 
| KOOS (Knee injury and Osteoarthritis Outcome Score) | Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4). | 6 weeks | 
| KOOS (Knee injury and Osteoarthritis Outcome Score) | Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4). | 6 months | 
| KOOS (Knee injury and Osteoarthritis Outcome Score) | Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4). | 24 months | 
| Tegner Lysholm Knee Scoring Scale | The Lysholm Knee Scoring Scale is a 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). | 6 weeks | 
| Tegner Lysholm Knee Scoring Scale | The Lysholm Knee Scoring Scale is a 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). | 6 months | 
| Tegner Lysholm Knee Scoring Scale | The Lysholm Knee Scoring Scale is a 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). | 24 months | 
| IKDC (International Knee Documentation Committee) subjective knee evaluation | IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. highr number representing higher levels of function. | 6 weeks | 
| IKDC (International Knee Documentation Committee) subjective knee evaluation | IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. highr number representing higher levels of function. | 6 months | 
| IKDC (International Knee Documentation Committee) subjective knee evaluation | IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. highr number representing higher levels of function. | 24 months | 
| SF-36 (36-Item Short Form Survey) | Quality of life | 6 weeks | 
| SF-36 (36-Item Short Form Survey) | Quality of life | 6 months | 
| SF-36 (36-Item Short Form Survey) | Quality of life | 24 months | 
| VAS (Visual analog scale) | The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best). | 6 weeks | 
| VAS (Visual analog scale) | Pain Visual Analog Scale The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best). | 6 months | 
| VAS (Visual analog scale) | Pain Visual Analog Scale The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best). | 24 months | 
| KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral) | the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability | 6 weeks | 
| KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral) | the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability | 6 months | 
| KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral) | the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, ALL