Status:
UNKNOWN
Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee
Lead Sponsor:
Peking University Third Hospital
Conditions:
Cartilage Injury
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The trial evaluates the clinical efficacy and safety of decalcification bone scaffold for cartilage lesions of the knee. Half of participants will receive decalcification bone scaffold combined with m...
Detailed Description
Decalcification bone scaffold is a tissue engineering scaffold with the closest biomechanics and structure of normal cartilage. The objective of the study is to evaluate the clinical efficacy of arthr...
Eligibility Criteria
Inclusion
- 18-50 years old, male or female
- Cartilage defect 2-8 cm²
- Subjects have the surgical indication of microfracture and no contradiction
- Subjects participate the clinical trial voluntarily, and sign informed consent
- Subjects could comply with follow-up
Exclusion
- Participated in other drug or medical device clinical trials in the last 6 months.
- Can not accept allogeneic decalcified bone due to religion, ethnic and other issues.
- Defect area 2 cm² or 8 cm² or lack of normal cartilage tissue around defect zone.
- Complex multi-ligament injury
- Suffered from systemic immune disease or systemic, locally infected
- Joint fibrosis, joint rigidity, mobility was significantly limited
- Moderate and severe osteoarthritis
- With contraindications to MRI
- Hemophilia
- General condition can not tolerate surgery
- Pregnant or planned pregnant women and lactating women
- With abnormal spirit and selfless ability
- Other circumstances judged by doctors that can not participate in the trial
Key Trial Info
Start Date :
September 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03321812
Start Date
September 11 2018
End Date
December 30 2023
Last Update
July 2 2020
Active Locations (1)
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1
Institute of Sports Medicine
Beijing, Beijing Municipality, China, 100000