Last updated: June 21, 2023
Sponsor: Geistlich Pharma AG
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Microfracture
Chondro-Gide bilayer collagen membrane
Clinical Study ID
NCT05785949
13575-238
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female patients aged 18-55 years (including 18 years and 55 years);
- Localized cartilage defects on knee joint, the size of the defect after debridement is 2.0 squared cm - 8.0 squared cm (including 2.0 squared cm and 8.0 squared cm), whichwas classified by the International Cartilage Repair Society (ICRS) as grade Ⅲ orgrade IV;
- The subjects voluntarily consent to participate in this trial and sign the informedconsent form (ICF).
Exclusion
Exclusion Criteria:
- Body mass index (BMI) ≥ 30 kg/meter squared (BMI = weight divided by height squared);
- Unilateral knee cartilage defect with the ICRS classification of grade III or gradeIV, and with three or more defects;
- Patients with abnormal lower limb mechanical axis requiring correction, except thosethat could be corrected during the treatment of cartilage injury;
- Varus or valgus of lower limb axis > 5°, requiring osteotomy for correction;
- Patients with multiple ligament injury or total meniscectomy;
- Those who are known to be allergic to porcine-derived materials or collagen, or refuseto use porcine-derived medical products;
- Those with severe arthroclisis or arthrofibrosis;
- Those who have received open knee surgery in the past 6 months;
- Those who have received microfracture, mosaicplasty or autologous cartilageimplantation in the past 3 months;
- Those who have serious primary cardiovascular diseases, lung diseases, endocrine andmetabolic diseases (severe diabetes, severe osteoporosis) or serious diseasesaffecting their survival, and are considered unsuitable for inclusion by theinvestigators;
- Pregnant and lactating women, or those who plan to conceive during the trial, andthose who have positive blood/urine pregnancy test results before the trial;
- Patients with knee infection;
- Those with connective tissue diseases;
- Those with nervous system diseases or muscle degeneration;
- Patients who participated in drug clinical trials within 3 months prior to theenrollment or patients who participated in any other device clinical trials within 1months prior to the enrollment;
- Other circumstances which are considered by the investigator not suitable forenrollment in this study.
Study Design
Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Microfracture
Phase:
Study Start date:
April 13, 2023
Estimated Completion Date:
February 14, 2027
Study Description
Connect with a study center
The Second Hospital of Jilin University
Changchun, 130041
ChinaActive - Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, 510632
ChinaActive - Recruiting
The Third Affiliated Hospital of Southern Medical University
Guangzhou, 510640
ChinaActive - Recruiting
The second affiliated hospital of Zhejiang University School of Medicine
Hanzhou, 310009
ChinaActive - Recruiting
Inner Mongolia People's Hospital
Hohhot, 010011
ChinaActive - Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, 650051
ChinaActive - Recruiting
The First Affiliated Hospital Of Nanchang University
Nanchang, 330209
ChinaActive - Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, 210008
ChinaActive - Recruiting
Peking University Third Hospital
Peking, 100191
ChinaActive - Recruiting
Sino-Japanese Friendship Hospital
Peking, 100013
ChinaActive - Recruiting
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