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

Knee Injuries Clinical Trial

— SECURE  

Official title:

A ProSpective, MulticEnter, Concurrently Controlled Clinical Study of Chondro-Gide® ArticUlar Cartilage CoveR for the Treatment of Large Chondral Lesions in the KnEe (SECURE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04537013
• Other study ID #: 13575-237
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: November 2026

Study information

• Verified date: March 2024
• Source: Geistlich Pharma AG
• Contact: Despoina Natsiou Schmiady, PhD
• Phone: +41 41 492 68 11
• Email: despoina.natsiou[@]geistlich.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: November 2026
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cartilage Disease
• Cartilage Diseases
• Cartilage Injury
• Knee Discomfort
• Knee Injuries
• Wounds and Injuries

Intervention

Procedure:
• Microfracture
Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells.

Device:
• Microfracture plus placement of Chondro-Gide® ACC
Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells, followed by affixing Chondro-Gide® with fibrin glue.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	CGY
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Fraser Orthopaedic Institute	New Westminster	British Columbia
Canada	Sunnybrook Research Institute (SRI)	Toronto	Ontario
Canada	University of Toronto Orthopaedics	Toronto	TOR
Germany	Martin Luther Krankenhaus	Berlin
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
United States	CORE Orthopaedic Medical Center	Encinitas	California
United States	Emory Sports Medicine Complex	Johns Creek	Georgia
United States	The MORE Foundation	Phoenix	Arizona
United States	Orthopaedic Foundation	Stamford	Connecticut
United States	MedStar Orthopaedics Institute	Timonium	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Geistlich Pharma AG

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS	The CCS is defined as a patient meeting all of the three following criteria: Improvement in the Pain sub-scale of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) between baseline to 24 months follow-up; Improvement in function, defined as an improvement in the International Knee Documentation Committee (IKDC) score between baseline to 24 months follow-up; Freedom from device- or procedure-related serious adverse events (SAEs) or secondary surgical intervention related to the device, procedure, or treated lesion	24 Months
Secondary	Knee Injury and Osteoarthritis Outcome Score	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.	Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary	Magnetic Resonance Observation of Cartilage Score	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.	3 months, 24 months
Secondary	Patient satisfaction	Were you satisfied with the procedure? (Satisfied, Somewhat satisfied, Neutral, Somewhat unsatisfied, Unsatisfied); Would you have this procedure again if needed on the other knee? (Definitely yes, Probably yes, Not Sure, Probably Not, Definitely Not)	6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary	Tegner Activity Scale	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	6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary	Employment status	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.	Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Secondary	EuroQol-5 Dimension (EQ-5D)	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.	Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months