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

Completed

• Conditions: Anterior Cruciate Ligament Reconstruction
• Interventions: Procedure: Anterior Cruciate Ligament Reconstruction

• Registration Number: NCT06058494
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2016-05-25
• Primary Completion: 2017-11-01
• Study Completion: 2021-03-01
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-22
• Last Update Submitted: 2023-09-22
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Double-Bundle	Anterior Cruciate Ligament Reconstruction	Double-bundle ACL reconstruction
Single-Bundle	Anterior Cruciate Ligament Reconstruction	Single-bundle ACL reconstruction
Single-Bundle+Lateral Plasty	Anterior Cruciate Ligament Reconstruction	Single-bundle ACL reconstruction with lateral plasty

Primary Outcome Measures

Name	Time	Method
Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Functional and Anatomical Model	18 months	MRI scans with T2 mapping will be performed on each patient to acquire the anatomical features, define the cartilage and graft status.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, BO, Italy