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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06058494

Acronym

MULTI-ACL

Enrollment

Registered

2023-09-28

Start date

2015-11-01

Completion date

2021-03-01

Last updated

2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

Anterior Cruciate Ligament, Reconstruction, Ligament modeling

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.

Interventions

PROCEDUREAnterior 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics	At baseline	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

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026