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

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

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.

Study Overview

• Status: Terminated
• Conditions: Knee Injuries; Cartilage Injury; Knee Discomfort; Cartilage Disease
• Intervention / Treatment: Procedure: Microfracture; Device: Microfracture plus placement of Chondro-Gide® ACC

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 0E4
      • Fraser Orthopaedic Institute
  • CGY
    • Calgary, CGY, Canada, T2N5A1
      • University of Calgary
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Hamilton Health Sciences
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute (SRI)
  • TOR
    • Toronto, TOR, Canada, M5S 1B2
      • University of Toronto Orthopaedics
• Germany
  • Lübeck, Germany
    • Universitatsklinikum Schleswig Holstein Campus Lubeck
  • München, Germany, 81369
    • Orthopädische Chirurgie München
  • Ravensburg, Germany
    • Sportklinik Ravensburg
  • Regensburg, Germany
    • University Hospital Regensburg
  • Mayen
    • Mayen, Mayen, Germany, 63 D-56727
      • Gelenkzentrum Mittelrhein GmbH
  • Schleswig-Holstein
    • Pinneberg, Schleswig-Holstein, Germany, 25421
      • Regio Kliniken GmbH
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • The MORE Foundation
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Orthopaedic Foundation
  • Georgia
    • Johns Creek, Georgia, United States, 30097
      • Emory Sports Medicine Complex

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm; Patients with small chondral lesions of the knee	Procedure: Microfracture; Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells.
Experimental: Investigational Group; Patients with large chondral lesions of the knee	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Geistlich Pharma AG
• Collaborators: Telos Partners
• Investigators: Principal Investigator: Kevin Plancher, MD, Plancher Orthopedics and Sports Medicine; Study Director: Fabiana Martinelli, Geistlich Pharma AG

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2020
• Primary Completion (Actual): September 25, 2025
• Study Completion (Actual): September 29, 2025

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Knee; Cartilage; Microfracture
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Connective Tissue Diseases; Leg Injuries; Fractures, Bone; Skin and Connective Tissue Diseases; Knee Injuries; Fractures, Stress; Cartilage Diseases; Surgical Procedures, Operative; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Arthroplasty, Subchondral
• Other Study ID Numbers: 13575-237

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: Yes
• product manufactured in and exported from the U.S.: No