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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-01

Study Completion Date

2021-03-01

Brief Summary

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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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Detailed Description

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Conditions

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Anterior Cruciate Ligament Reconstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single-Bundle

Single-bundle ACL reconstruction

Anterior Cruciate Ligament Reconstruction

Intervention Type 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.

Single-Bundle+Lateral Plasty

Single-bundle ACL reconstruction with lateral plasty

Anterior Cruciate Ligament Reconstruction

Intervention Type 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.

Double-Bundle

Double-bundle ACL reconstruction

Anterior Cruciate Ligament Reconstruction

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No