Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction

Study Overview
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Brief Summary
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The objective of this clinical trial is provide in vivo data thus to model the ligament biomechanical behavior within the physiologically healthy joint and to use the implemented model to predict risk and success rates focusing on knee joint Anterior Cruciate Ligament (ACL) reconstruction. Current ACL surgery offers 3 alternatives: autografts, allografts and bioengineered grafts; the choice of the implant and its characteristics still remains a critical point. The knowledge of patient-specific joint and graft biomechanics is fundamental to reduce surgical revision rate and low functional outcome. This clinical trial will provide data coming from patient-specific biomechanics into a prognostic computational model, able to provide information on both the optimal customized reconstruction and graft status during the early rehabilitation phase. This patient-specific approach will lead to quicker return to sports activity, reducing also the possibility of early osteoarthritis.

Official Title
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Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction

Conditions
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Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Procedure: Anterior Cruciate Ligament Reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary ACL lesion Ability to read and sign the informed consent. Age between 16 and 50 years old Exclusion Criteria: Prior surgeries at the same knee Grade II or higher lesions at the collateral ligaments Posterior Cruciate Ligament lesion Inflammatory arthritis or other forms systemic inflammatory diseases Local or systemic infections Any injury or condition that adversely affects the ability to walk or to participate to I/II level activities Previous or concomitant lesions at the contralateral knee Skeletal immaturity Other potential risk factors for the development of osteoarthritis

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 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 |
| --- | --- |
| Single-Bundle<br>Single-bundle ACL reconstruction | Procedure: Anterior Cruciate Ligament Reconstruction<br>* Reconstruction of the anterior cruciate ligament by means of the three reported techniques, namely single-bundle, single-bundle with extraarticular tenodesis and anatomic double-bundle.<br>|
| Single-Bundle+Lateral Plasty<br>Single-bundle ACL reconstruction with lateral plasty | Procedure: Anterior Cruciate Ligament Reconstruction<br>* Reconstruction of the anterior cruciate ligament by means of the three reported techniques, namely single-bundle, single-bundle with extraarticular tenodesis and anatomic double-bundle.<br>|
| Double-Bundle<br>Double-bundle ACL reconstruction | Procedure: Anterior Cruciate Ligament Reconstruction<br>* Reconstruction of the anterior cruciate ligament by means of the three reported techniques, namely single-bundle, single-bundle with extraarticular tenodesis and anatomic double-bundle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics | Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones. | At baseline | 
| Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics | Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones. | 4 months | 
| Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics | Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional and Anatomical Model | MRI scans with T2 mapping will be performed on each patient to acquire the anatomical features, define the cartilage and graft status. | at 4 months | 
| Functional and Anatomical Model | MRI scans with T2 mapping will be performed on each patient to acquire the anatomical features, define the cartilage and graft status. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cruciate Ligament, Reconstruction, Ligament modeling