Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee
NCT ID: NCT03321812
Last Updated: 2020-07-02
Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-09-11
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
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.
Microfracture
Microfracture is a conventional treatment for cartilage lesions of the knee.
microfracture
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.
microfracture
Microfracture is the surgical option for conventional treatment of cartilage defects.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Ao Yingfang
Director of the Institute of Sports Medicine , Principal Investigator, Clinical Professor of Orthopedic Sports Medicine
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PKU-AO-01
Identifier Type: -
Identifier Source: org_study_id
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