Clinical trial NCT06058494: Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction
Official title: Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Anterior Cruciate Ligament
Reconstruction
Ligament modeling
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2023-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics
timeFrame: At baseline
measure: Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics
timeFrame: 4 months
measure: Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics
timeFrame: 18 months
Secondary outcomes:
measure: Functional and Anatomical Model
timeFrame: at 4 months
measure: Functional and Anatomical Model
timeFrame: 18 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Stefano Zaffagnini, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Ortopedico Rizzoli
name: Nicola Francesco Lopomo, Prof
role: STUDY_DIRECTOR
affiliation: Istituto Ortopedico Rizzoli
name: Cecilia Signorelli, PhD
role: STUDY_CHAIR
affiliation: Istituto Ortopedico Rizzoli
name: Marco Bontempi, PhD
role: STUDY_CHAIR
References: