Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction
MULTI-ACL
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedSeptember 28, 2023
September 1, 2023
2 years
May 25, 2016
September 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics
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
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
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 Outcomes (2)
Functional and Anatomical Model
at 4 months
Functional and Anatomical Model
18 months
Study Arms (3)
Single-Bundle
Single-bundle ACL reconstruction
Single-Bundle+Lateral Plasty
Single-bundle ACL reconstruction with lateral plasty
Double-Bundle
Double-bundle ACL reconstruction
Interventions
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.
Eligibility Criteria
Patients with primary lesion of the anterior cruciate ligament (ACL), assessed by clinical manouvers and confirmed by means of MRI.
You may qualify if:
- Primary ACL lesion
- Ability to read and sign the informed consent.
- Age between 16 and 50 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istituto Ortopedico Rizzolilead
- Ministry of Health, Italycollaborator
Study Sites (1)
Istituto Ortopedico Rizzoli
Bologna, BO, 40136, Italy
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2016
First Posted
September 28, 2023
Study Start
November 1, 2015
Primary Completion
November 1, 2017
Study Completion
March 1, 2021
Last Updated
September 28, 2023
Record last verified: 2023-09