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This is a first-in-human clinical, open label, non-randomized, prospective investigation to assess the initial safety and performance of the COPLA® cartilage implant. In the investigation, the patients will receive COPLA® device during normal clinical practice for cartilage repair surgery with bone marrow stimulation.
Included subjects will be symptomatic patients between the ages 18 and 50 years with a single contained chondral or osteochondral defect located on the femoral condyle and graded as III or IV according to the International Cartilage Repair Society (ICRS) grading system. Subjects with known health related risks or certain recent surgical or medical interventions will be excluded.
The primary objective of the investigation is to confirm that COPLA® device is safe for humans. The secondary objectives relate to the performance of the device after it is placed into the knee joint during surgery. Focus points of secondary objectives will be facilitation of mobility and non-restricted weight-bearing of the operated leg as well as the identification of repair tissue growth at the lesion site.
Post-operative follow-up is planned for 24 months after surgery. Subject will come for scheduled visits at 6-week, 3-month, 6-month, 12-month, and 24-month timepoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPLA® cartilage implant | Experimental | The potential subjects will be screened against inclusion and exclusion criteria. If deemed eligible, they will be consented and enrolled. The enrolled subjects will receive COPLA® device during normal clinical practice for cartilage repair surgery with bone marrow stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COPLA® cartilage implant | Device | In the investigation, the subjects will receive COPLA® device during normal clinical practice for cartilage repair surgery of the knee with bone marrow stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events (SAE) | Safety - Measured by number of SAE and evaluated over the course of the clinical investigation | From pre-operative baseline up to 24-month follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Defect filling | Measured by the change in repair tissue quality evaluated according to Magnetic Resonance Imaging (MRI) Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART 2.0) | From pre-operative baseline up to 24-month follow-up visit |
| Change in pain score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Hospital | Tartu | Estonia | ||||
| Mehiläinen |
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Measured by the change in pain score according to the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale (scale from never to always). |
| From pre-operative baseline up to 24-month follow-up visit |
| Functional outcome | Measured by the change in joint function scores according to the KOOS joint function subscales (degree of difficulty, scale from none to extreme). | From pre-operative baseline up to 24-month follow-up visit |
| Change in Quality of life | Measured by the change to 12-Item Short Form Survey (SF-12) Health Survey (scale from excellent to poor). | From pre-operative baseline up to 24-month follow-up visit |
| Helsinki |
| Finland |
| Terveystalo | Helsinki | Finland |
| Central Finland Health Care District | Jyväskylä | Finland |
| Terveystalo | Jyväskylä | Finland |
| Sahlgrenska University hospital | Gothenburg | Mölndal | Sweden |