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Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.
Agili-C™ implant is a CE marked, bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects.
The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Agili C™ | Other | Candidates will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Agili-C™ implantation procedure | Device | Candidates for Agili-C™ implantation will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| • The KOOS Pain Subscale relative to baseline | The KOOS pain subscale is evaluated at 6m, 12m, 18m & 24m | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| • Improvement in other KOOS subscales relative to baseline | Other KOOS subscales are evaluated at 6m, 12m, 18m & 24m | 24 Months |
| • Improvement in IKDC Subjective Knee Score relative to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizaveta Kon, MD | Rizzoli Institute, Bologna , Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | Austria | ||||
| AZ Monica |
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|
IKDC Subjective Knee Score is evaluated at 6m, 12m, 18m & 24m
| 24 Months |
| • Improvement in SF-36 Survey | SF-36 Survey is evaluated at 6m, 12m, 18m & 24m | 24 Months |
| • Improvement in Tegner Score | Tegner Score is evaluated at 6m, 12m, 18m & 24m | 24 Months |
| • Improvement in Lysholm Knee Scoring Scale | Lysholm Knee Scoring Scale is evaluated at 6m, 12m, 18m & 24m | 24 Months |
| • Joint Space maintenance rate according to X-ray | Joint Space maintenance rate is evaluated at 12m & 24m | 24 Months |
| • Defect Fill according to MRI | Defect Fill according to MRI is evaluated at 6m, 12m, 18m & 24m | 24 Months |
| Improvement of Overall KOOS (average of all KOOS Subscales) relative to baseline | The KOOS Overall is evaluated at 6, 12,18 & 24 months | 24 mMonths |
| Antwerp |
| Belgium |
| Hasharon medical center | Petah Tikva | Israel |
| Rizzoli Orthopaedic Institute | Bologna | Italy |
| Specialist Hospital. Louis Rydygier | Krakow | Poland |
| Timişoara County Hospital | Timișoara | Romania |
| Institut za Ortopedsko-hirurške Bolesti "banjica" | Belgrade | Serbia |
| University Medical Centre Ljubljana | Ljubljana | Slovenia |