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

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Reconstruction
• Intervention / Treatment: Procedure: Anterior Cruciate Ligament Reconstruction

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40136
      • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary lesion of the anterior cruciate ligament (ACL), assessed by clinical manouvers and confirmed by means of MRI.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single-Bundle; Single-bundle ACL reconstruction	Procedure: Anterior Cruciate Ligament Reconstruction; 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.
Single-Bundle+Lateral Plasty; Single-bundle ACL reconstruction with lateral plasty	Procedure: Anterior Cruciate Ligament Reconstruction; 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.
Double-Bundle; Double-bundle ACL reconstruction	Procedure: Anterior Cruciate Ligament Reconstruction; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Collaborators: Ministry of Health, Italy
• Investigators: Principal Investigator: Stefano Zaffagnini, Prof, MD, Istituto Ortopedico Rizzoli; Study Director: Nicola Francesco Lopomo, Prof, Istituto Ortopedico Rizzoli; Study Chair: Cecilia Signorelli, PhD, Istituto Ortopedico Rizzoli; Study Chair: Marco Bontempi, PhD, Istituto Ortopedico Rizzoli

Publications and helpful links

Helpful Links

• Institutional Website

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Anterior Cruciate Ligament; Reconstruction; Ligament modeling
• Other Study ID Numbers: 0023352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED