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Prospective and randomized validation of the effectiveness and safety of cartilage-bone integration functional stent in knee joint cartilage injury

Prospective and randomized validation of the effectiveness and safety of cartilage-bone integration functional stent in knee joint cartilage injury

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047319
Enrollment
Unknown
Registered
2021-06-12
Start date
2021-06-04
Completion date
Unknown
Last updated
2022-02-01

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

Conditions

Focal articular cartilage defect

Interventions

Group A:Mesenchymal stem cells cultured on stents
Group B:Subchondral bone drilling treatment

Sponsors

The 920th Hospital of the PLA Joint Service Support Force
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 55 years; 2. Acute or chronic knee cartilage injury caused by trauma or peeling osteochondrolitis in an area between 2.0 to 10cm2; 3. Before the study began, the subject was willing and able to sign an informed consent form approved by the Ethics Committee; 4. Willing to cooperate closely with the rigorous postoperative rehabilitation procedures developed by doctors; 5. Willing to cooperate with the entire process and to bear the consequences or associated complications, and the corresponding postoperative treatment measures; 6. Judged by the researchers that the subject could understand the clinical study and cooperate with the whole process; 7. The subjects were able to read, express, and understand the study protocol, and could provide feedback in the appropriate language.

Exclusion criteria

Exclusion criteria: 1. Patients were obese with BMI >= 30kg/m2; 2. Type X legs or Type O legs; 3. A known history of immune system disease and causes damage to the joint and meniscus; 4. Kellgren & Lawrence grade III and above arthritis with large meniscus damage; 5. There are serious heart, liver, kidney, and lung insufficiency; 6. Pregnant women or lactating women; 7. Infected with HIV or drug addict; 8. Knee cavity bacterial infection or purulent arthritis; 9. Patients with tissue metabolic disorders, immune disorders, immune disorders, hematopoietic system, endocrine system and other serious primary disorders or mental disorders, such as coagulation dysfunction, serious diabetes, drug abuse, etc.; 10. Poor compliance, such as reluctance or inability to restrict activity, follow medical advice, and failure to follow up on time; 11. Involved in another clinical study within 6 months; 12. Suffered from diseases that the researchers believe could affect their participation in the study, such as mental disorders, alcohol or drug addiction, malignancy, or serious illness; 13. Subjects were accompanied by severe nervous system or musculoskeletal diseases such as myasthenia gravis, dystrophy, cerebral infarction, cerebral palsy, etc.; 14. Subjects could not express, read, express and understand the study protocol and could provide feedback in the appropriate language. 15. Subjects had other diseases with a life expectancy of less than 2 years; 16. The subject was participating in other clinical trials and did not reach the endpoint; 17. Other patients who were not suitable for this trial.

Design outcomes

Primary

MeasureTime frame
Affected limb X line, MRI;

Countries

China

Contacts

Public ContactTan Hongbo

The 920th Hospital of the PLA Joint Service Support Force

tantoo@163.com+86 13116955623

Outcome results

None listed

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