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| Name | Class |
|---|---|
| Ministry of Health, Italy | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Bundle | Single-bundle ACL reconstruction |
| |
| Single-Bundle+Lateral Plasty | Single-bundle ACL reconstruction with lateral plasty |
| |
| Double-Bundle | Double-bundle ACL reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Cruciate Ligament Reconstruction | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional and Anatomical Model | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with primary lesion of the anterior cruciate ligament (ACL), assessed by clinical manouvers and confirmed by means of MRI.
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Zaffagnini, Prof, MD | Istituto Ortopedico Rizzoli | Principal Investigator |
| Nicola Francesco Lopomo, Prof | Istituto Ortopedico Rizzoli | Study Director |
| Cecilia Signorelli, PhD | Istituto Ortopedico Rizzoli | Study Chair |
| Marco Bontempi, PhD | Istituto Ortopedico Rizzoli | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | BO | 40136 | Italy |
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| Label | URL |
|---|---|
| Institutional Website | View source |
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| ID | Term |
|---|---|
| D059549 | Anterior Cruciate Ligament Reconstruction |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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MRI scans with T2 mapping will be performed on each patient to acquire the anatomical features, define the cartilage and graft status.
| 18 months |