Guided Cartilage Regeneration Membrane
GCRM
Randomized Open Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Guided Cartilage Regeneration Membrane for Repair of Articular Cartilage Injury
1 other identifier
interventional
150
1 country
8
Brief Summary
Guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2020
CompletedFirst Posted
Study publicly available on registry
July 9, 2020
CompletedStudy Start
First participant enrolled
August 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2023
CompletedJuly 9, 2020
July 1, 2020
2 years
July 3, 2020
July 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
MRI evaluation of articular cartilage injury 730 days (2 years) after repair
The nuclear magnetic evaluation indicators are as follows: 1. Cartilage defect repair filling degree; 2. Fusion of repair tissue and adjacent normal cartilage; 3. Repair tissue surface structure; 4. Repair the internal structure of the organization. The MRI score of the experimental group before and after treatment increased by an average of 5 points compared with the control group.
End of surgery to 730 days after surgery
Secondary Outcomes (2)
Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value
At 24 months after surgery
Change in ratio of regenerated cartilage △R1 value to normal cartilage △R1 value
At 24 months after surgery
Study Arms (2)
Cartilage membrane surgery
EXPERIMENTALThe test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd. Cartilage regeneration membrane combined with microfracture surgery.
Microfracture
OTHERThe control group was treated with microfractures widely recognized at home and abroad.
Interventions
On the basis of microfracture, the blood clot released from the defect area is covered with a guide cartilage regeneration membrane to provide an attached scaffold for the cells in the blood clot.
Operate in accordance with the clinical microfracture surgery method.
Eligibility Criteria
You may qualify if:
- ≥18 years old and ≤50 years old, regardless of gender
- cm2 ≤ articular cartilage defect repair area ≤ 8 cm2, patients with feasible micro-fractures, no contraindications to surgery
- Patients voluntarily participate in clinical trials, sign informed consent forms, and can cooperate with clinical follow-up
You may not qualify if:
- Those who have participated in clinical trials of other drugs or medical devices in the last 6 months
- Those with stage III or above degeneration of bone and joint
- Those who cannot accept pig-derived devices or have special religious beliefs due to religion, ethnicity and other issues
- Those who are sensitive to collagen, foreign protein or pig-derived materials
- Repair the damaged area\> 8 cm2 or \<2 cm2, lack of normal cartilage tissue around the injury
- Severe heart, liver and kidney insufficiency are defined as:
- Heart function: NYHA grade III or above; ALT, AST\> 2.5 times the upper limit of normal value; Serum creatinine\> 1.5 times the upper limit of normal value;
- People with systemic immune diseases or systemic or local infections
- Joint fibrosis, joint stiffness, and obviously restricted movement
- Those with moderate or severe osteoarthritis
- People with contraindications for MRI examination
- Patients with hemophilia
- Those who cannot tolerate surgery
- Women who are pregnant or plan to become pregnant and breastfeeding women
- Persons with mental abnormalities and incapacity to act autonomously
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking University Third Hospitallead
- Zhongnan Hospitalcollaborator
- Second Hospital of Shanxi Medical Universitycollaborator
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schoolcollaborator
- First Affiliated Hospital of Kunming Medical Universitycollaborator
- Zunyi Medical Collegecollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Chinese PLA General Hospitalcollaborator
- Xi'an Honghui Hospitalcollaborator
Study Sites (8)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Zunyi Medical College
Zunyi, Guizhou, 563000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Zhongnan Hospital
Wuhan, Hubei, 430071, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030012, China
Xi'an Honghui Hospital
Xi’an, Shanxi, 710000, China
The First Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, 650032, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yingfang Ao, PhD
Department of Sports Medicine, Peking University Third Hospital
- STUDY DIRECTOR
Xiaoqing Hu, PhD
Department of Sports Medicine, Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2020
First Posted
July 9, 2020
Study Start
August 3, 2020
Primary Completion
August 3, 2022
Study Completion
August 3, 2023
Last Updated
July 9, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share