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

September 22, 2023 updated by: Istituto Ortopedico Rizzoli
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline
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.
4 months
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.
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
at 4 months
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Ortopedico Rizzoli

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, Italy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0023352

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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