Status:
UNKNOWN
Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee
Lead Sponsor:
Arthro-Anda Tianjin Biologic Technology Co., Ltd.
Conditions:
Cartilage Defects
Eligibility:
All Genders
18-55 years
Phase:
NA
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 ca...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03307668
Start Date
January 1 2014
End Date
December 31 2019
Last Update
October 12 2017
Active Locations (1)
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1
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410008