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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03307668
• Other study ID #: 3.0
• Status: Recruiting
• Phase: N/A
• First received: August 24, 2017
• Last updated: October 6, 2017
• Start date: January 1, 2014
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2017
• Source: Arthro-Anda Tianjin Biologic Technology Co., Ltd.
• Contact: Dong-xing Xie, PhD
• Phone: 86073189753006
• Email: 491703175[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cartilage Defects

Intervention

Device:
• CaReSR-1S
CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I.
• Microfracture
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.

Locations

Country	Name	City	State
China	Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Arthro-Anda Tianjin Biologic Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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