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A prospective, randomized, single-blind clinical study to verify the efficacy and safety of medical collagen in the treatment of knee cartilage injury

A prospective, randomized, single-blind clinical study to verify the efficacy and safety of medical collagen in the treatment of knee cartilage injury

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054839
Enrollment
Unknown
Registered
2021-12-28
Start date
2021-12-27
Completion date
Unknown
Last updated
2022-12-12

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

Conditions

Knee cartilage defect

Interventions

Experimental group (Medical collagen treatment group):Medical collagen therapy
Control group (currently clinically used subchondral bone drilling treatment group):Subchondral drilling

Sponsors

920th Hospital of Joint Logistic Support Force
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. The patient's gender is not limited, and aged 18-55 years; 2. Acute or chronic knee meniscus injury caused by trauma; 3. Before the start of the study, the subjects are willing and able to sign the informed consent form approved by the ethics committee; 4. Willing to cooperate closely with the strict postoperative rehabilitation procedures formulated by the doctor; 5. The patient himself is willing to cooperate with the whole treatment process, and is willing to bear the corresponding consequences or related complications after the treatment process, and the corresponding postoperative treatment measures; 6. According to the judgment of the researcher, the subjects can understand the clinical research and can cooperate to complete the whole research process; 7. Subjects are able to read, express and understand the content of the research protocol and can provide feedback in appropriate language.

Exclusion criteria

Exclusion criteria: 1. The patient is too obese, with a BMI index >= 30kg/m^2; 2. X-leg or O-leg; 3. Known history of immune system disease and cause joint and meniscus damage; 4. Kellgren & Lawrence grade III and above arthritis with extensive damage to the meniscus; 5. Severe heart, liver, kidney and lung insufficiency; 6. Pregnant women and lactating women; 7. Known HIV-infected persons or drug addicts; 8. Bacterial infection of the knee joint cavity or septic arthritis; 9. Patients with serious primary diseases such as metabolic disorders, immune dysfunction, hematopoietic system, endocrine system, or mental diseases, such as coagulation disorders, severe diabetes, drug abuse, etc.; Participate in another clinical study within 10.6 months; 11. Suffering from diseases that the researchers believe may affect their participation in this research, such as mental disorders, alcohol or drug addiction, malignant or serious illness, etc.; 12. Subjects with severe neurological or musculoskeletal diseases, such as myasthenia gravis, muscular dystrophy, cerebral infarction, cerebral palsy, etc.; 13. The subject has other diseases and the life expectancy is less than 2 years; 14. The subjects are participating in other clinical trials and have not reached the endpoint; 15. Other patients considered by the investigator to be unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
MRI;

Countries

China

Contacts

Public ContactTan Hongbo

920th Hospital of Joint Logistic Support Force

Fengyujiao07@163.com+86 13116955623

Outcome results

None listed

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