Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee
NCT ID: NCT03307668
Last Updated: 2017-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2014-01-01
2019-12-31
Brief Summary
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Detailed Description
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The physical nature of the CaReSR-1S allows the in-growth of healthy chondrocytes, as well as progenitor cells from the surrounding healthy tissue.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CaReS-1S
CaReSR-1S
CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I.
Microfracture
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
No
Sponsors
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Arthro-Anda Tianjin Biologic Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Xiangya Hospital, Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Guang-hua Lei
Role: primary
Other Identifiers
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3.0
Identifier Type: -
Identifier Source: org_study_id