Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Among High Demand Patients

Study Overview
=================
Brief Summary
-----------------
Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis between high demand patients

Detailed Description
-----------------
It is a randomized control trial comparing between isolated anterior cruciate ligament reconstruction with and without lateral extra articular tenodesis between high demand and high risk groups with high pivot regarding failure rate (primary out come) and patient reported functions score (IKDC and Lysholm)

Official Title
-----------------
of Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Between High Demand Patients: Randomized Controlled Trial

Conditions
-----------------
Anterior Cruciate Ligament Tear

Intervention / Treatment
-----------------
* Procedure: Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis
* Procedure: Isolated anterior cruciate ligament reconstruction only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High demand patients (manual workers, athletes,...etc.). Normal average body mass index ( 18.5 - 24.9 ). Age <40 years old. Patients will be diagnosed as ACL tear by the following: History of knee traumatic event. Clinical examination ( positive Lachman test and pivot shift test). Radiological evidence of ACL tear by MRI. patient with high pivot shift test. Exclusion Criteria: Generalized ligamentous laxity. Other intra or extra articular knee injuries. Previous ACL surgery on the affected knee. Bilateral ACL injuries. Significant Articular surface injury. Medical comorbidities Patients with malalignment ( genu varum, genu valgum or genu recurvatum ) Neuromuscular disorders Knee arthritic changes.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis<br>Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction with modified Lemiere technique for extra-articular tenodesis | Procedure: Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis<br>* Anatomical single bundle ACLR with modified Lemiere technique<br>|
| Active Comparator: Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis<br>Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction only | Procedure: Isolated anterior cruciate ligament reconstruction only<br>* arthroscopic anatomical single bundle ACL Reconstruction<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure rate | retear of ACL graft confirmed by clinical examination and MRI | one year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International knee documentation committee score (IKDC) | The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms) | at 3,6,9,12 months | 
| Lysholm score | The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. Physicians use this condition-specific, subjective outcome score to assess patient progress after surgery or injury to the knee. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms) | at 3,6,9,12 months | 
| antero-posterior instability measure | measure AP instability by KT1000 lachmeter for injured and non injured knee | at 3,6,9 and 12 months | 
| side to side KT 1000 lachmeter difference | measure side to side KT 1000 lachmeter difference by (injured - noninjured) | one year follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anterior cruciate ligament tear, anterolateral instability, retear, extra articular tenodesis