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

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.

Study Overview

• Status: Recruiting
• Conditions: Cartilage Injury
• Intervention / Treatment: Procedure: decalcification bone scaffold; Procedure: microfracture

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoqing Hu, Phd; Phone Number: +8613401096777; Email: aoyingfang@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Institute of Sports Medicine
      • Contact: Xiaoqing Hu, Phd; Phone Number: +8613401096777; Email: aoyingfang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: decalcification bone scaffold; Decalcification bone scaffold is a novel tissue engineered acellular matrix scaffold with the closest biomechanics and structure to normal cartilage.	Procedure: decalcification bone scaffold; Decalcification bone scaffold is a tissue engineering acellular matrix scaffold with the closest biomechanics and structure of normal cartilage.; Procedure: microfracture; Microfracture is the surgical option for conventional treatment of cartilage defects.
Active Comparator: Microfracture; Microfracture is a conventional treatment for cartilage lesions of the knee.	Procedure: microfracture; Microfracture is the surgical option for conventional treatment of cartilage defects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appraise of magnetic reasonance imaging	Evaluate the articular cartilage postoperatively by MRI.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
International Knee Documentation Committee (IKDC) 2000	International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.	5 years
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
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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Yingfang Ao, MD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2018
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: randomized controlled trial; microfracture; decalcification bone scaffold; cartilage lesions of the knee
• Other Study ID Numbers: PKU-AO-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No