Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee (NCT03321812) | Clinical Trial Compass
UnknownNot Applicable
Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee
China60 participantsStarted 2018-09-11
Plain-language 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 microfracture, while the other will only receive microfracture as a control group.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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