An interventional study of CaReSR-1S and Microfracture in Cartilage Defects, sponsored by Arthro-Anda Tianjin Biologic Technology Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-10-12.
Sponsored by Arthro-Anda Tianjin Biologic Technology Co., Ltd. · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Device: CaReSR-1S
Device: Microfracture
CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I.
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 Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups
Time frame: 12 months
Difference of MOCART score change from baseline between groups
Time frame: 12 months
Difference of International Knee Documentation Committee (IKDC) Subjective Knee Form score change from baseline between groups
Time frame: 12 months
Difference of Lysholm score change from baseline between groups
Time frame: 12 months
"Good""Moderate""Poor" rates according to Lysholm score
Time frame: 12 months
Effective rate according to Lysholm score
Time frame: 12 months
Total efficiency according to Lysholm score
Time frame: 12 months
Incidence of treatment-related adverse events
Time frame: 12 months
Plan to share: No
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