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

NCT06058494 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2023-09-28

No results posted yet for this study

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.

Conditions

  • Anterior Cruciate Ligament Reconstruction

Interventions

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.

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Stefano Zaffagnini, Prof, MD · Istituto Ortopedico Rizzoli

  • Nicola Francesco Lopomo, Prof · Istituto Ortopedico Rizzoli

  • Cecilia Signorelli, PhD · Istituto Ortopedico Rizzoli

  • Marco Bontempi, PhD · Istituto Ortopedico Rizzoli

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-01
Primary Completion
2017-11-01
Completion
2021-03-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06058494 on ClinicalTrials.gov