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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    60
  • sponsor
    Peking University Third Hospital
Updated on 25 January 2021

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.

Details
Condition Cartilage Injury
Treatment Microfracture, decalcification bone scaffold
Clinical Study IdentifierNCT03321812
SponsorPeking University Third Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

-50 years old, male or female
Cartilage defect 2-8 cm
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 cm or 8 cm 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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