Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee

Study Overview
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Brief Summary
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The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee cartilage defects.

Detailed Description
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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.

Official Title
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Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee: a Randomised, Multicentre, Open-label, Controlled Trial

Conditions
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Cartilage Defects

Intervention / Treatment
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* Device: CaReSR-1S
* Device: Microfracture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 18 to 55 years old; Diagnosed with isolated knee cartilage defects in condyles of femur by arthroscopy, and the longest diameter is 1.1-2.2cm. The degree of the cartilage defects is Outerbridge IV degree or III degree but approximate to IV degree; Outerbridge degree of cartilage in the other articular facet ≤Ⅱ; Normal lower limb mechanical force line (varus or valgum < 5°); Skeletal mature; 18Kg/M2 ≤ BMI ≤ 30Kg/M2; Agree to sign the informed consent form; Can cooperate in a post-operative rehabilitation program. Exclusion Criteria: Superficial cartilage defects; Concomitant with subchondral bone defect; Varus or valgum > 5°; Serious meniscus injury; Fractures around the knee; Cannot join in the post-operative rehabilitation program; The contralateral lower-limb cannot stand weight-bearing; A history of knee surgery within 6 months; Secondary arthritis affecting cartilage; Serious arthrocleisis; Undergoing clinical trial; Serious illness of the heart, lung, and other vital organs; Liver function test equal to two times or greater than the upper normal limits; serum creatinine equal to two times or greater than the upper normal limit; Have a contagious disease; Allergic to the agents; Lactating or pregnant women; Serious neuropathy or mental disease; Be addicted with drug or alcohol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CaReS-1S<br> | Device: CaReSR-1S<br>* CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I.<br>|
| Active Comparator: Microfracture<br> | Device: Microfracture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Difference of Lysholm score change from baseline between groups |  | 12 months | 
| GoodModeratePoor 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 |