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

Cartilage Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03321812
• Other study ID #: PKU-AO-01
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2020
• Source: Peking University Third Hospital
• Contact: Xiaoqing Hu, phd
• Phone: +8613401096777
• Email: aoyingfang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cartilage Injury

Intervention

Procedure:
• decalcification bone scaffold
Decalcification bone scaffold is a tissue engineering acellular matrix scaffold with the closest biomechanics and structure of normal cartilage.
• microfracture
Microfracture is the surgical option for conventional treatment of cartilage defects.

Locations

Country	Name	City	State
China	Institute of Sports Medicine	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appraise of magnetic reasonance imaging	Evaluate the articular cartilage postoperatively by MRI.	5 years
Secondary	Lysholm score	The Lysholm score consists of eight items including limping, locking, pain, stair climbing, use of supports, instability, swelling, and squatting. The higher values represent a better outcome.	5 years
Secondary	International Knee Documentation Committee (IKDC) 2000	International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.	5 years
Secondary	Tegner activity level score	The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome.	5 years
Secondary	Visual analogue scale	The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. From 0 to 10, no pain 0, worst pain imaginable 10. The higher values represent a worse outcome.	5 years