Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054926
Enrollment
Unknown
Registered
2021-12-29
Start date
2021-12-26
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Osteochondral lesions of the talus

Interventions

Experimental group:Repair talus cartilage defect with medical collagen
Control group:Subchondral bone drilling to repair cartilage defects

Sponsors

920th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. No gender limitation, aged 18-55 years. 2. Acute or chronic talus cartilage injury caused by trauma or exudative osteochonitis, with injury area between 2.0 ~ 4.0 cm^2. 3. Before the study, the subjects were willing and able to sign the informed consent. 4. Patient is willing to cooperate closely with the strict postoperative rehabilitation procedures established by the doctors. 5. Patient is willing to cooperate with the whole treatment process, and is willing to bear the corresponding consequences or complications caused by the treatment process, as well as the corresponding postoperative treatment measures. 6. According to the judgment of the researcher, the subjects can understand the clinical study and cooperate to complete the whole study process. 7. Subjects can read, express and understand the content of the study plan, and provide feedback information in appropriate language.

Exclusion criteria

Exclusion criteria: 1. Patient was obese, with a BMI index of >= 30 kg/m^2. 2. X-leg or O-leg. 3. Known history of immune system disease that causes joint and meniscus damage. 4. Severe arthritis with extensive damage to the articular cartilage, cannot be treated with this technique. 5. Severe heart, liver, kidney and lung insufficiency. 6. Pregnant women and lactating women. 7. Known HIV-infected persons. 8. Bacterial infection of the ankle joint cavity or septic arthritis. 9. Patients with severe primary diseases or mental diseases such as metabolic disorders, immune dysfunction, hematopoietic system, endocrine system, etc., such as coagulation disorders, severe diabetes, drug abuse, etc. 10. Poor compliance, such as unwilling or inability to limit activities, follow doctor's orders, and fail to follow up on time. 11. To participate in another clinical study within 6 months. 12. Suffering from diseases that the researchers believe may affect their participation in this study, such as mental disorders, alcohol or drug addiction, malignant or serious illness, etc. 13. Subjects with severe neurological or musculoskeletal diseases, such as myasthenia gravis, muscular dystrophy, cerebral infarction, cerebral palsy, etc. 14. Subjects cannot express, read and understand the content of the research protocol, and cannot provide feedback in appropriate language. 15. The subject has other diseases and the life expectancy is less than 2 years. 16. Subjects are participating in other clinical trials and have not reached the endpoint. 17. Other patients considered by the investigator to be unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
MRI;AROM (active range of motion);

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