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

February 11, 2026 updated by: Geistlich Pharma AG

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS
Time Frame: 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
24 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score
Time Frame: 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.
Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Patient satisfaction
Time Frame: 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)
6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Tegner Activity Scale
Time Frame: 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
6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Employment status
Time Frame: 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.
Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
EuroQol-5 Dimension (EQ-5D)
Time Frame: 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.
Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Magnetic Resonance Observation of Cartilage Score
Time Frame: 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.
3 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Geistlich Pharma AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Telos Partners

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kevin Plancher, MD, Plancher Orthopedics and Sports Medicine
  • Study Director: Fabiana Martinelli, Geistlich Pharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 26, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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