Cartilage Defects
Conditions
Brief summary
The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee cartilage defects.
Detailed description
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.
Interventions
DEVICECaReSR-1S
CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I.
DEVICEMicrofracture
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.
Sponsors
Arthro-Anda Tianjin Biologic Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Aged from 18 to 55 years old; 2. 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; 3. Outerbridge degree of cartilage in the other articular facet ≤Ⅱ; 4. Normal lower limb mechanical force line (varus or valgum \< 5°); 5. Skeletal mature; 6. 18Kg/M2 ≤ BMI ≤ 30Kg/M2; 7. Agree to sign the informed consent form; 8. Can cooperate in a post-operative rehabilitation program.
Exclusion criteria
1. Superficial cartilage defects; 2. Concomitant with subchondral bone defect; 3. Varus or valgum \> 5°; 4. Serious meniscus injury; 5. Fractures around the knee; 6. Cannot join in the post-operative rehabilitation program; 7. The contralateral lower-limb cannot stand weight-bearing; 8. A history of knee surgery within 6 months; 9. Secondary arthritis affecting cartilage; 10. Serious arthrocleisis; 11. Undergoing clinical trial; 12. Serious illness of the heart, lung, and other vital organs; 13. 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; 14. Have a contagious disease; 15. Allergic to the agents; 16. Lactating or pregnant women; 17. Serious neuropathy or mental disease; 18. Be addicted with drug or alcohol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Difference of MOCART score change from baseline between groups | 12 months |
| Total efficiency according to Lysholm score | 12 months |
| Incidence of treatment-related adverse events | 12 months |
| Effective rate according to Lysholm score | 12 months |
Countries
China
Contacts
Primary ContactDong-xing Xie, PhD
Outcome results
None listed