Cartilage Defects Clinical Trial
Official title:
Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee: a Randomised, Multicentre, Open-label, Controlled Trial
The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee cartilage defects.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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 =?; 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. |
Country | Name | City | State |
---|---|---|---|
China | Xiangya Hospital, Central South University | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Arthro-Anda Tianjin Biologic Technology Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups | 12 months | ||
Secondary | Difference of MOCART score change from baseline between groups | 12 months | ||
Secondary | Difference of International Knee Documentation Committee (IKDC) Subjective Knee Form score change from baseline between groups | 12 months | ||
Secondary | Difference of Lysholm score change from baseline between groups | 12 months | ||
Secondary | "Good""Moderate""Poor" rates according to Lysholm score | 12 months | ||
Secondary | Effective rate according to Lysholm score | 12 months | ||
Secondary | Total efficiency according to Lysholm score | 12 months | ||
Secondary | Incidence of treatment-related adverse events | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05785949 -
Chondro-Gide® Bilayer Collagen Membrane in Knee Cartilage Defect Repair
|
N/A |