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Completed

NCT Number: NCT06058494

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

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.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anterior cruciate ligament reconstruction

Procedure

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.

Primary outcomes

  1. Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics

    Time frame: 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.

  2. Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics

    Time frame: 4 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.

  3. Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics

    Time frame: 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 outcomes

  1. Functional and Anatomical Model

    Time frame: 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.

  2. Functional and Anatomical Model

    Time frame: 18 months

    MRI scans with T2 mapping will be performed on each patient to acquire the anatomical features, define the cartilage and graft status.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

  • Ministry of Health, Italy

Registry information

Acronym: MULTI-ACL

Important dates

Study start
2015
Primary completion
2017
Study completion
2021
First posted
Sep 28, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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