Individualized Anterior Cruciate Ligament Versus Conventional Reconstruction

Study Overview
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Brief Summary
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A randomised prospective control trial comparing the efficiency of a more individualized approach in ACL reconstruction with the help of neuromuscular computer models with traditional ACL reconstruction practices.

Detailed Description
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Until now the ACL reconstruction was based on the surgeon's experience. An individualised ACL reconstruction is customized based on each patient's special characteristics. Preoperative and intraoperative evaluation of the native ACL (both anteromedial and posterolateral bundles), knee anatomy and function, level of activity and generalised ligamentous laxity are assessed. Femoral and tibial tunnels should be placed in their anatomical location accounting for both the native ACL insertion site and bony landmarks. Two groups will be created, one with patients undergoing ACL reconstruction based on a surgeon's experience and one based on a more individualised approach according to the particular characteristics of each patient separately. In addition, patients in the second group will undergo ACL reconstruction with the use of Computer Assisted System (Navigation). Preoperatively and postoperatively, the patients will be assessed with the KT2000 system, the KOOS (Knee injury and Osteoarthritis Outcome), the Tegner- Lysholm Knee scoring system and the IKDC (International Knee Documentation Committee). Additionally, all patient will be examined for their knee function with the use of a 3D gait analysis system. The follow-up examination will take place 6 and 12 months after the surgery.

Official Title
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Anterior Cruciate Ligament Surgical Reconstruction Based on Individualized Musculoskeletal Models: a Randomized Control Trial

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Procedure: Individualised ACL reconstruction
* Procedure: Conventional ACL reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ACL rupture undergoing ACL reconstruction surgery with closed epiphyses, younger than 45 years old Exclusion Criteria: No previous surgery in the knee (except partial meniscectomy), no major systematic pathology

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 45 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
Interventional Model Description: Two groups of patients, randomly assigned
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Convetional reconstruction group<br>Patients will undergo ACL reconstruction based on conventional ACL surgery | Procedure: Conventional ACL reconstruction<br>* ACL reconstruction based on surgeons experience without taking into account any other patients characteristics<br>|
| Experimental: Individualised reconstruction group<br>Patients will undergo ACL reconstruction based on their special anatomical and functional characteristics and with the use of a navigation system | Procedure: Individualised ACL reconstruction<br>* ACL reconstruction based on anatomical and functional distinctiveness of each patient separately<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the change of stability of the operated knee between the two groups from Baseline until 1 year post-operation | Participants in two groups will be assessed with KT2000 arthrometer before and after ACL reconstruction regarding knee stability. Additionally knee kinematics and gait analysis before and after the ACL reconstruction will be compared between the two groups in a gait analysis lab. | Baseline and 1 year post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the change from Baseline between the patients of the two groups in KOOS (Knee Injury & Osteoarthritis Outcome) from the baseline until 1 year post operation | Originally published in 1998 in The Journal of Orthopaedic and Sports Physical Therapy, the Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment. | Baseline and 1 year post operation | 
| Compare the change from Baseline between the patients of the two groups in IKDC (International Knee Documentation Committee Subjective Knee Form) from the baseline until 1 year post operation. | the International Knee Documentation Committee Subjective Knee Form (IKDC) was designed to assess patients with a variety of knee disorders including ligamentous and meniscal injuries as well as patellofemoral pain and osteoarthritis. 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). | Baseline and 1 year post operation | 
| Compare the change from Baseline between the patients of the two groups in Tegner Lysholm Knee Scoring Scale from the baseline until 1 year post operation. | Lysholm Knee Scoring Scale was designed to be used for evaluating outcomes of knee ligament surgery, particularly for symptoms related to instability. The Lyshom 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). | Baseline and 1 year post operation | 
| Compare the post operation MRI of the 2 groups | Evaluate tunnel positioning in femur and tibia and the graft integration and compare them between the 2 groups. | 1 year post operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, Anterior, Cruciate, Ligament, Reconstruction, Individualised, Anatomical, Navigation