Back to resultsGuided Cartilage Regeneration Membrane (GCRM)
Primary Purpose
Articular Cartilage Injury, Knee Ligament Injury
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Guided cartilage regeneration membrane
Microfracture
Sponsored by
About this trial
This is an interventional treatment trial for Articular Cartilage Injury
Eligibility Criteria
Inclusion Criteria:
- ≥18 years old and ≤50 years old, regardless of gender
- 2 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
Exclusion Criteria:
- 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
- Other conditions that the doctor judges cannot participate in the trial
Sites / Locations
- Chinese PLA General Hospital
- Zunyi Medical College
- The First Affiliated Hospital of Zhengzhou University
- Zhongnan Hospital
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Second Hospital of Shanxi Medical University
- Xi'an Honghui Hospital
- The First Affiliated Hospital of Kunming Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Cartilage membrane surgery
Microfracture
Arm Description
The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd. Cartilage regeneration membrane combined with microfracture surgery.
The control group was treated with microfractures widely recognized at home and abroad.
Outcomes
Primary Outcome Measures
MRI evaluation of articular cartilage injury 730 days (2 years) after repair
The nuclear magnetic evaluation indicators are as follows:
Cartilage defect repair filling degree;
Fusion of repair tissue and adjacent normal cartilage;
Repair tissue surface structure;
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.
Secondary Outcome Measures
Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value
The closer the ratio of the regenerated cartilage T2 value to the normal control cartilage T2 value is 1, it means that the regenerated cartilage The closer the water content and collagen arrangement are to normal cartilage.
Change in ratio of regenerated cartilage △R1 value to normal cartilage △R1 value
The closer the ratio of the regenerated cartilage △R1 value to the normal control cartilage △R1 value is 1, it means that the GAG content of regenerated cartilage is closer to normal cartilage.
Full Information
NCT ID
NCT04463238
First Posted
July 3, 2020
Last Updated
July 3, 2020
Sponsor
Peking University Third Hospital
Collaborators
Zhongnan Hospital, Second Hospital of Shanxi Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Kunming Medical University, Zunyi Medical College, The First Affiliated Hospital of Zhengzhou University, Chinese PLA General Hospital, Xi'an Honghui Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04463238
Brief Title
Guided Cartilage Regeneration Membrane
Acronym
GCRM
Official Title
Randomized Open Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Guided Cartilage Regeneration Membrane for Repair of Articular Cartilage Injury
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 3, 2020 (Anticipated)
Primary Completion Date
August 3, 2022 (Anticipated)
Study Completion Date
August 3, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Zhongnan Hospital, Second Hospital of Shanxi Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Kunming Medical University, Zunyi Medical College, The First Affiliated Hospital of Zhengzhou University, Chinese PLA General Hospital, Xi'an Honghui Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury
Detailed Description
MRI evaluation using guided cartilage regeneration membrane for articular cartilage injury repair 730 days (2 years) is the main indicator of this trial. In this experiment, we observe the improvement of Lysholm score, VAS score, ratio change of regenerated cartilage T2 value to normal cartilage T2 value, and ratio of regenerated cartilage △R1 value to normal cartilage △R1 value Indicators such as value changes are secondary evaluation indicators.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular Cartilage Injury, Knee Ligament Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
GCRM-3020\GCRM-4030
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cartilage membrane surgery
Arm Type
Experimental
Arm Description
The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd.
Cartilage regeneration membrane combined with microfracture surgery.
Arm Title
Microfracture
Arm Type
Other
Arm Description
The control group was treated with microfractures widely recognized at home and abroad.
Intervention Type
Combination Product
Intervention Name(s)
Guided cartilage regeneration membrane
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Microfracture
Intervention Description
Operate in accordance with the clinical microfracture surgery method.
Primary Outcome Measure Information:
Title
MRI evaluation of articular cartilage injury 730 days (2 years) after repair
Description
The nuclear magnetic evaluation indicators are as follows:
Cartilage defect repair filling degree;
Fusion of repair tissue and adjacent normal cartilage;
Repair tissue surface structure;
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.
Time Frame
End of surgery to 730 days after surgery
Secondary Outcome Measure Information:
Title
Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value
Description
The closer the ratio of the regenerated cartilage T2 value to the normal control cartilage T2 value is 1, it means that the regenerated cartilage The closer the water content and collagen arrangement are to normal cartilage.
Time Frame
At 24 months after surgery
Title
Change in ratio of regenerated cartilage △R1 value to normal cartilage △R1 value
Description
The closer the ratio of the regenerated cartilage △R1 value to the normal control cartilage △R1 value is 1, it means that the GAG content of regenerated cartilage is closer to normal cartilage.
Time Frame
At 24 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥18 years old and ≤50 years old, regardless of gender
2 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
Exclusion Criteria:
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
Other conditions that the doctor judges cannot participate in the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingfang Ao, PhD
Phone
13401096777
Ext
13401096777
Email
gcrm_bys01@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingfang Ao, PhD
Organizational Affiliation
Department of Sports Medicine, Peking University Third Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaoqing Hu, PhD
Organizational Affiliation
Department of Sports Medicine, Peking University Third Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing Municipality
ZIP/Postal Code
100853
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongli Li, PhD
First Name & Middle Initial & Last Name & Degree
Zhongli Li, PhD
Facility Name
Zunyi Medical College
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Liu, Bachelor
First Name & Middle Initial & Last Name & Degree
Hehe Zhong, PhD
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianzhong Xu, PhD
First Name & Middle Initial & Last Name & Degree
Jianzhong Xu, PhD
Facility Name
Zhongnan Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liaobin Chen, PhD
First Name & Middle Initial & Last Name & Degree
Biao Chen, PhD
Facility Name
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Jiang, PhD
First Name & Middle Initial & Last Name & Degree
Jin Dai, PhD
Facility Name
Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030012
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiqiang Zhang, Postgraduate
First Name & Middle Initial & Last Name & Degree
Junjun Shi, PhD
Facility Name
Xi'an Honghui Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Zheng, PhD
First Name & Middle Initial & Last Name & Degree
Jiang Zheng, PhD
Facility Name
The First Affiliated Hospital of Kunming Medical College
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanlin Li, PhD
First Name & Middle Initial & Last Name & Degree
Yanlin Li, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Guided Cartilage Regeneration Membrane
We'll reach out to this number within 24 hrs