Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee

Peking University

Status: Unknown

Conditions: Cartilage Injury

Treatments: Procedure: decalcification bone scaffold; Procedure: microfracture

Study type: Interventional

Funder types: Other

Identifiers

NCT03321812

PKU-AO-01

Details and patient eligibility

About

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.

Full 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 arthroscopic decalcification bone scaffold combined with microfracture in the repairment of articular cartilage defects by randomized controlled trial. Sixty patients with clinically diagnosed knee cartilage injury according to 1: 1 were divided into experimental group and control group. The experimental group will be treated with decalcification bone scaffold combined with microfracture .The control group will be treated with microfracture . The patients will be treated by the same surgeon in this study group. MRI evaluation, Lysholm score, IKDC score, Tegner score, VAS score are selected as the measures of outcome, while the blood routine, blood biochemistry, urine, CRP, ECG and other laboratory tests will be recorded inclduing the incidence of adverse events.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

decalcification bone scaffold

Experimental group

Description:

Decalcification bone scaffold is a novel tissue engineered acellular matrix scaffold with the closest biomechanics and structure to normal cartilage.

Treatment:

Procedure: decalcification bone scaffold

Procedure: microfracture

Microfracture

Active Comparator group

Description:

Microfracture is a conventional treatment for cartilage lesions of the knee.

Treatment:

Procedure: microfracture