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

Anterior Cruciate Ligament Reconstruction Clinical Trial

— MULTI-ACL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06058494
• Other study ID #: 0023352
• Status: Completed
• Start date: November 1, 2015
• Est. completion date: March 1, 2021

Study information

• Verified date: September 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2021
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna	BO

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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

External Links

•   Institutional Website