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

A Prospective, Multicenter, Randomized, Parallel Controlled Study Evaluating the Safety and Efficacy of Chondro-Gide® Bilayer Collagen Membrane in Knee Cartilage Defect Repair

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

Study Overview

• Status: Recruiting
• Conditions: Cartilage Defects
• Intervention / Treatment: Procedure: Microfracture; Device: Chondro-Gide bilayer collagen membrane

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Despoina Natsiou Schmiady, Dr.; Phone Number: +41 41 492 68 11; Email: despoina.natsiou@geistlich.com

Study Locations

• China
  • Changchun, China, 130041
    • Recruiting
    • The Second Hospital of Jilin University
  • Guangzhou, China, 510632
    • Recruiting
    • The First Affiliated Hospital of Jinan University
  • Guangzhou, China, 510640
    • Recruiting
    • The Third Affiliated Hospital of Southern Medical University
  • Hanzhou, China, 310009
    • Recruiting
    • The second affiliated hospital of zhejiang university school of medicine
  • Hohhot, China, 010011
    • Recruiting
    • Inner Mongolia People's Hospital
  • Kunming, China, 650051
    • Recruiting
    • The First Affiliated Hospital of Kunming Medical University
  • Nanchang, China, 330209
    • Recruiting
    • The First Affiliated Hospital of NanChang University
  • Nanjing, China, 210008
    • Recruiting
    • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Peking, China, 100013
    • Recruiting
    • Sino-Japanese Friendship Hospital
  • Peking, China, 100191
    • Recruiting
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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), which was classified by the International Cartilage Repair Society (ICRS) as grade Ⅲ or grade IV;
3. The subjects voluntarily consent to participate in this trial and sign the informed consent form (ICF).

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 grade IV, and with three or more defects;
3. Patients with abnormal lower limb mechanical axis requiring correction, except those that 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 refuse to 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 cartilage implantation in the past 3 months;
10. Those who have serious primary cardiovascular diseases, lung diseases, endocrine and metabolic diseases (severe diabetes, severe osteoporosis) or serious diseases affecting their survival, and are considered unsuitable for inclusion by the investigators;
11. Pregnant and lactating women, or those who plan to conceive during the trial, and those 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 the enrollment or patients who participated in any other device clinical trials within 1 months prior to the enrollment;
16. Other circumstances which are considered by the investigator not suitable for enrollment in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Microfracture	Procedure: Microfracture; Use of standard tool kit to drill vertically from the periphery to the center with a hole spacing of 3~4 mm with care to prevent penetrating adjacent holes. The hole depth should be 3~5 mm and fat droplets or blood oozing is seen after loosening the tourniquet. However, no blood oozing is observed in some holes and in such case, the hole depth should be deepened to 5~7 mm.
Experimental: Microfracture + Chondro-Gide®; Microfracture + Chondro-Gide® bilayer collagen membrane	Procedure: Microfracture; Use of standard tool kit to drill vertically from the periphery to the center with a hole spacing of 3~4 mm with care to prevent penetrating adjacent holes. The hole depth should be 3~5 mm and fat droplets or blood oozing is seen after loosening the tourniquet. However, no blood oozing is observed in some holes and in such case, the hole depth should be deepened to 5~7 mm.; Device: Chondro-Gide bilayer collagen membrane; After the Microfracture, the porous layer of the bilayer collagen membrane faces the bone surface. The already trimmed, cut and wetted membrane is insert into the defect and fixed symmetrically with absorbable surgical suture with needle. Knots are put on the pinhole of collagen membrane to avoid tearing of surrounding cartilage or collagen membrane during knotting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)	Cartilage repair is evaluated by MOCART score from nine aspects, such as degree of defect repair and filling of the defect, integration to border zone, surface of repair tissue, structure of the repair tissue, adhesions and subchondral lamina.	24 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Knee Documentation Committee (IKDC) score	The therapeutic effect for subjects is evaluated based on the difference between IKDC score at the different timepoints. The score ranges from 0 - 87 points, where higher scores mean a better outcome.	before operation and at 3, 6, 12 and 24 months postoperative
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)	Cartilage repair is evaluated by MOCART score from nine aspects, such as degree of defect repair and filling of the defect, integration to border zone, surface of repair tissue, structure of the repair tissue, adhesions and subchondral lamina. The Score ranges from 0 - 100, where higher scores mean a better outcome.	6 and 12 months postoperative
Hyaline cartilage production (T2 mapping ratio)	Please refer to YY/T 1636-2018 Tissue engineering medical device products-In vivo evaluation of knee cartilage implanted tissue using MRI technique for the specific operation, measurement and evaluation method of T2 mapping technology of MRI.	12 and 24 months postoperative
Lysholm score	The Lysholm score is assessing patient's knee specific symptoms. The total Lysholm score is 100 (0: worst, 100: best).	before operation and at 3, 6, 12 and 24 months postoperative
Device performance evaluation questionnaire	The investigator evaluates the performance of the device based on a questionnaire. The evaluation criteria are as follows. There are three answer options to every question: Is the product operation convenient?; Is the product easy to trim?; Is the product easy to fix?; Is the product compliant after being fixed?	perioperative (after surgical intervention), on the day of surgery
Safety indicators; adverse events and device deficiencies	Incidence (%) and number of (serious) adverse events, and those of device-related (serious) adverse events;; Incidence (%) and number of device deficiencies;	through study completion, an average of 2 years
Safety indicators; Laboratory examination	Determination of clinical significance of laboratory examination: 1) normal; 2) abnormal but without clinical significance; 3) abnormal with clinical significance; 4) not examined. If the clinical significance is judged as 3) abnormal with clinical significance, the abnormality is explained, followed up, and reexamined until normal or reaching baseline level or stable.	before operation, 7 days and 6 months postoperative

Collaborators and Investigators

• Sponsor: Geistlich Pharma AG
• Collaborators: TigerMed
• Investigators: Study Director: Despoina Natsiou Schmiady, Dr., Geistlich Pharma AG

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): April 14, 2025
• Study Completion (Estimated): February 14, 2027

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Chondro-Gide®
• Other Study ID Numbers: 13575-238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No