Chondro-Gide® Bilayer Collagen Membrane in Knee Cartilage Defect Repair

Last updated: June 21, 2023
Sponsor: Geistlich Pharma AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Microfracture

Chondro-Gide bilayer collagen membrane

Clinical Study ID

NCT05785949
13575-238
  • Ages 18-55
  • All Genders

Study Summary

A prospective, multicenter, randomized, parallel controlled study evaluating the safety and efficacy of Chondro-Gide® bilayer collagen membrane in knee cartilage defect repair. The objective of this clinical trial is to evaluate the efficacy and safety of Chondro-Gide® bilayer collagen membrane in knee cartilage defect repair

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female patients aged 18-55 years (including 18 years and 55 years);
  2. 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;
  3. The subjects voluntarily consent to participate in this trial and sign the informedconsent form (ICF).

Exclusion

Exclusion Criteria:

  1. Body mass index (BMI) ≥ 30 kg/meter squared (BMI = weight divided by height squared);
  2. Unilateral knee cartilage defect with the ICRS classification of grade III or gradeIV, and with three or more defects;
  3. Patients with abnormal lower limb mechanical axis requiring correction, except thosethat could be corrected during the treatment of cartilage injury;
  4. Varus or valgus of lower limb axis > 5°, requiring osteotomy for correction;
  5. Patients with multiple ligament injury or total meniscectomy;
  6. Those who are known to be allergic to porcine-derived materials or collagen, or refuseto use porcine-derived medical products;
  7. Those with severe arthroclisis or arthrofibrosis;
  8. Those who have received open knee surgery in the past 6 months;
  9. Those who have received microfracture, mosaicplasty or autologous cartilageimplantation in the past 3 months;
  10. 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;
  11. 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;
  12. Patients with knee infection;
  13. Those with connective tissue diseases;
  14. Those with nervous system diseases or muscle degeneration;
  15. 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;
  16. 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

This is a prospective, multicenter, randomized, parallel controlled and superiority clinical trial. It is planned to be carried out in hospitals with qualifications as a national-level clinical trial institution. Subjects who have signed the ICF, meet all inclusion criteria and do not meet any exclusion criteria will be included in this study. Subjects included will be randomly assigned into the experimental group and the control group at a ratio of 1:1. Those in the control group will receive microfracture, and those in the experimental group will receive microfracture plus Chondro-Gide® bilayer collagen membrane. The primary efficacy evaluation indicator of this clinical study is the MOCART score at 24 months postoperative. The secondary efficacy evaluation indicators are IKDC score (before operation, 3, 6, 12 and 24 months postoperative), MOCART score (6 and 12 months postoperative), hyaline cartilage production (T2 mapping ratio) (12 and 24 months postoperative), Lysholm score (before operation, 3, 6, 12 and 24 months postoperative), and device performance evaluation of the investigational product. Safety evaluation indicators include adverse events (or serious adverse events), device-related adverse events (or serious adverse events), device deficiencies and laboratory examination.

Connect with a study center

  • The Second Hospital of Jilin University

    Changchun, 130041
    China

    Active - Recruiting

  • The First Affiliated Hospital of Jinan University

    Guangzhou, 510632
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Southern Medical University

    Guangzhou, 510640
    China

    Active - Recruiting

  • The second affiliated hospital of Zhejiang University School of Medicine

    Hanzhou, 310009
    China

    Active - Recruiting

  • Inner Mongolia People's Hospital

    Hohhot, 010011
    China

    Active - Recruiting

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, 650051
    China

    Active - Recruiting

  • The First Affiliated Hospital Of Nanchang University

    Nanchang, 330209
    China

    Active - Recruiting

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, 210008
    China

    Active - Recruiting

  • Peking University Third Hospital

    Peking, 100191
    China

    Active - Recruiting

  • Sino-Japanese Friendship Hospital

    Peking, 100013
    China

    Active - Recruiting

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