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The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee cartilage defects.
CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I. It is indicated for the defect filling of focal, full layer and clearly defined knee and ankle cartilage defects of longest diameter 1.1-2.2cm. The fixation of CaReSR-1S is made for all sizes with fibrin glue, whereas the 11 mm implants also allow a press-fit anchoring due to the elasticity of the implant.
The physical nature of the CaReSR-1S allows the in-growth of healthy chondrocytes, as well as progenitor cells from the surrounding healthy tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CaReS-1S | Experimental |
| |
| Microfracture | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CaReSR-1S | Device | CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of MOCART score change from baseline between groups | 12 months | |
| Difference of International Knee Documentation Committee (IKDC) Subjective Knee Form score change from baseline between groups | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong-xing Xie, PhD | Contact | 86073189753006 | 491703175@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | 410008 | China |
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| ID | Term |
|---|---|
| D054544 | Arthroplasty, Subchondral |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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| Microfracture | Device | Microfracture is an articular cartilage repair surgical technique that works by creating tiny fractures in the underlying bone. This causes new cartilage to develop from a so-called super-clot. |
|
| Difference of Lysholm score change from baseline between groups | 12 months |
| "Good""Moderate""Poor" rates according to Lysholm score | 12 months |
| Effective rate according to Lysholm score | 12 months |
| Total efficiency according to Lysholm score | 12 months |
| Incidence of treatment-related adverse events | 12 months |