Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee

Not Applicable

Active, not recruiting

• Conditions: Cartilage Injury; Cartilage Disease; Knee Injuries; Knee Discomfort
• Interventions: Procedure: Microfracture; Device: Microfracture plus placement of Chondro-Gide® ACC

• Registration Number: NCT04537013
• Lead Sponsor: Geistlich Pharma AG

Brief Summary

Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment of small chondral lesions treated with microfracture alone.

Detailed Description

The study evaluates the investigational treatment for treating large chondral lesions of the knee to the control treatment of microfracture alone for treating small lesions.Eligible patients with a large lesion will be treated with microfracture plus the Chondro-Gide® ACC and compared to patients with small lesions that are treated with microfracture alone. Outcome measures to be assessed include patient reported outcomes and freedom from certain adverse events.

Study Timeline

• Study First Submitted: 2020-08-18
• Study Start: 2020-08-26
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-09-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

1. Signed written informed consent
2. One symptomatic knee with cartilage defect on the medial femoral condyle, lateral femoral condyle, or trochlea, identified MRI or arthroscopy
3. Between 18 and 55 years of age
4. Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, and the rehabilitation protocol

Exclusion Criteria

1. BMI ≥ 30 kg/m2
2. Symptomatic contralateral knee
3. Diagnosis of radiographic osteoarthritis with Kellgren-Lawrence grade 3 or more
4. Prior surgical treatment of the cartilage using microfracture, mosaicplasty, or autologous chondrocyte implantation (debridement and lavage are acceptable if the procedure was at least 3 months prior to enrollment)
5. Patella dysplasia
6. Chronic inflammatory arthritis or infectious arthritis
7. History of autoimmune disease or immunodeficiency
8. History of connective tissue disease
9. Intra-articular steroid use within the 3 months prior to enrollment
10. Other intra-articular injections (e.g. hyaluronic acid) within 3 months prior to enrollment
11. The patient is currently being treated with radiation, chemotherapy, immunosuppression or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone
12. Pregnancy or lack of adequate contraceptives if a female of child-bearing potential
13. Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the study
14. Active infection of the index knee
15. Previous diagnosis of osteoporosis as diagnosed by DEXA, bone densitometry or CT scan
16. Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions
17. History or current substance or alcohol abuse as defined by the DSM-V
18. Any other medical condition that the investigator determines would interfere with the validity of the study
19. Known allergy to porcine collagen
20. Symptom duration greater than 36 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Microfracture	Patients with small chondral lesions of the knee
Investigational Group	Microfracture plus placement of Chondro-Gide® ACC	Patients with large chondral lesions of the knee

Primary Outcome Measures

Name	Time	Method
Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS	24 Months	The CCS is defined as a patient meeting all of the three following criteria: 1. Improvement in the Pain sub-scale of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) between baseline to 24 months follow-up; 2. Improvement in function, defined as an improvement in the International Knee Documentation Committee (IKDC) score between baseline to 24 months follow-up; 3. Freedom from device- or procedure-related serious adverse events (SAEs) or secondary surgical intervention related to the device, procedure, or treated lesion

Secondary Outcome Measures

Name	Time	Method
Magnetic Resonance Observation of Cartilage Score	3 months, 24 months	Magnetic Resonance Image (MRI) will be obtain during the course of the study at 3 months and 24 months. MOCART 2.0 scoring will occur by independent assessment using the MOCART score. The score is a 9-part and 29-item scoring system, also resulting in a final cartilage repair tissue score between 0 and 100 points; 0 points represent the worst imaginable score, 100 points represent the best imaginable score.
Knee Injury and Osteoarthritis Outcome Score	Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months	The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. Calculate the mean score of the individual items of each subscale and divide by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems.
Patient satisfaction	6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months	1. Were you satisfied with the procedure? (Satisfied, Somewhat satisfied, Neutral, Somewhat unsatisfied, Unsatisfied); 2. Would you have this procedure again if needed on the other knee? (Definitely yes, Probably yes, Not Sure, Probably Not, Definitely Not)
Tegner Activity Scale	6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months	The Tegner activity score is a one-item score that grades activity based on work and sports activities. Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. A scale of the highest level activity being 10 and the lowest being 0
Employment status	Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months	Employment status will be collected as: Employed full-time, Employed part-time, Not employed due to knee problems, Not employed due to reasons other than knee problems.
EuroQol-5 Dimension (EQ-5D)	Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months	The EQ-5D measures as a descriptive system comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

Trial Locations

Locations (15)

The MORE Foundation; 🇺🇸 Phoenix, Arizona, United States

Orthopaedic Foundation; 🇺🇸 Stamford, Connecticut, United States

Emory Sports Medicine Complex; 🇺🇸 Johns Creek, Georgia, United States

Fraser Orthopaedic Institute; 🇨🇦 New Westminster, British Columbia, Canada

University of Calgary; 🇨🇦 Calgary, CGY, Canada

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada

Sunnybrook Research Institute (SRI); 🇨🇦 Toronto, Ontario, Canada

University of Toronto Orthopaedics; 🇨🇦 Toronto, TOR, Canada

Regio Kliniken GmbH; 🇩🇪 Pinneberg, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig Holstein Campus Lübeck; 🇩🇪 Lübeck, Germany

Gelenkzentrum Mittelrhein GmbH; 🇩🇪 Mayen, Germany

Orthopädische Chirurgie München; 🇩🇪 München, Germany

Sportklinik Ravensburg; 🇩🇪 Ravensburg, Germany

University Hospital Regensburg; 🇩🇪 Regensburg, Germany