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

NCT ID: NCT03321812

Last Updated: 2020-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cartilage Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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decalcification bone scaffold

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

Group Type EXPERIMENTAL

decalcification bone scaffold

Intervention Type PROCEDURE

Decalcification bone scaffold is a tissue engineering acellular matrix scaffold with the closest biomechanics and structure of normal cartilage.

microfracture

Intervention Type PROCEDURE

Microfracture is the surgical option for conventional treatment of cartilage defects.

Microfracture

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

Group Type ACTIVE_COMPARATOR

microfracture

Intervention Type PROCEDURE

Microfracture is the surgical option for conventional treatment of cartilage defects.

Interventions

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decalcification bone scaffold

Decalcification bone scaffold is a tissue engineering acellular matrix scaffold with the closest biomechanics and structure of normal cartilage.

Intervention Type PROCEDURE

microfracture

Microfracture is the surgical option for conventional treatment of cartilage defects.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ao Yingfang

Director of the Institute of Sports Medicine , Principal Investigator, Clinical Professor of Orthopedic Sports Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yingfang Ao, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Institute of Sports Medicine

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoqing Hu, phd

Role: CONTACT

+8613401096777

Facility Contacts

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Xiaoqing Hu, Phd

Role: primary

+8613401096777

Other Identifiers

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PKU-AO-01

Identifier Type: -

Identifier Source: org_study_id

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