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A randomized, parallel-controlled, multi-center and non-inferiority clinical trial to evaluate the safety and effectiveness of the cartilage repair materials for knee cartilage damage repair

A randomized, parallel-controlled, multi-center and non-inferiority clinical trial to evaluate the safety and effectiveness of the cartilage repair materials for knee cartilage damage repair

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080978
Enrollment
Unknown
Registered
2024-02-19
Start date
2023-10-09
Completion date
Unknown
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee cartilage injury repair

Interventions

experimental:Intraoperative implantation of experimental group medical device "cartilage repair material"
control:Adopt "micro fracture surgery" for treatment

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Gender is not limited, 18-60 years old, in good physical condition, able to tolerate surgery; 2) According to the damage diagnosis standard, Outerbridge is graded III and IV cartilage injury; 3) MRI evaluates the patient's large area (1-8cm²) of cartilage defects; 4) No severe joint degeneration and extraarticular deformity; 5) Informed consent: The subject must have the ability to understand and voluntarily sign written informed consent and follow the research plan and visit process;

Exclusion criteria

Exclusion criteria: 1) If the knee osteoarthritis is more than three stages, and the angle of valgus and valgus exceeds 5 degrees; 2) MRI indicates severe lower cartilage injury, combined with severe meniscus injury on the same side, and all meniscus needs to be removed; 3) Allergic constitution, such as a previous medical or family history of autoimmune diseases; 4) Those who have received bone marrow mesenchymal stem cell transplantation for cartilage defects in the affected side knee joint within 12 months before surgery, or other cartilage regeneration surgery; 5) Knee cartilage injury is caused by joint fracture, infection, tumor and immune diseases. 6) People infected with viruses or microorganisms; 7) Knee joint tumors, rheumatism, rheumatoids, tuberculosis, suppuration and complications affect joint structure; 8) Secondary knee arthritis with psoriasis and metabolic osteopathy; 9) Those who often use sedatives, sleeping pills, tranquillizers or other addictive drugs; 10) Combined with uncontrollable hypertension (drug-controlled hypertension >140mmHg, low blood pressure >100mmHg), diabetes (Used by drugs to control fasting blood glucose still >8.0mmol/L), liver and kidney function abnormalities (i.e. ALT, AST > 2.5 times normal value; creatinine > normal value 2 times); uric acid > 1.5 times normal value; 11) Those who cannot receive long-term rehabilitation training after surgery; 12) Women during family planning, breastfeeding and pregnancy within 12 months; 13) Special believers, from cattle sources; 14) Patients with body mass index BMI32; 15) Those deemed unsuitable by the researchers;

Design outcomes

Primary

MeasureTime frame
At 12 months post surgery, MOCART score was performed through magnetic resonance imaging;

Secondary

MeasureTime frame
Lysholm Knee Function Score;Tegner Knee Motion Level Score;IKDC score;VAS pain score;Operational satisfaction;

Countries

China

Contacts

Public ContactJianquan Wang

Department of Sports Medicine, Peking University Third Hospital

sheng.zeng@ssbiotec.com+86 130 2679 6616

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026