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Knee InjuriesSECURENCT04537013

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

A study testing Microfracture and Microfracture plus placement of Chondro-Gide® ACC in people with Knee Injuries and Cartilage Injury, run by Geistlich Pharma AG at 15 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Knee Injuries, Cartilage Injury, Cartilage Disease
What is being tested?
Microfracture and Microfracture plus placement of Chondro-Gide® ACC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
15 sitesin 3 countries
Study dates
26 Aug 2020to 29 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • BMI ≥ 30 kg/m2
  • Symptomatic contralateral knee
  • Diagnosis of radiographic osteoarthritis with Kellgren-Lawrence grade 3 or more
  • 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)
  • Patella dysplasia
  • Chronic inflammatory arthritis or infectious arthritis
Show all 20Show fewer
  • History of autoimmune disease or immunodeficiency
  • History of connective tissue disease
  • Intra-articular steroid use within the 3 months prior to enrollment
  • Other intra-articular injections (e.g. hyaluronic acid) within 3 months prior to enrollment
  • The patient is currently being treated with radiation, chemotherapy, immunosuppression or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone
  • Pregnancy or lack of adequate contraceptives if a female of child-bearing potential
  • Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the study
  • Active infection of the index knee
  • Previous diagnosis of osteoporosis as diagnosed by DEXA, bone densitometry or CT scan
  • Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions
  • History or current substance or alcohol abuse as defined by the DSM-V
  • Any other medical condition that the investigator determines would interfere with the validity of the study
  • Known allergy to porcine collagen
  • Symptom duration greater than 36 months

Trial locations and contacts

15 sites in 3 countries.

15 sites in 3 countries

Canada6 sites

  • University of Calgary

    Calgary, CGY, T2N5A1

  • Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Fraser Orthopaedic Institute

    New Westminster, British Columbia, V3L 0E4

  • Sunnybrook Research Institute (SRI)

    Toronto, Ontario, M4N 3M5

  • University of Toronto Orthopaedics

    Toronto, TOR, M5S 1B2

Other trials in Canada

Germany6 sites

  • Universitätsklinikum Schleswig Holstein Campus Lübeck

    Lübeck

  • Gelenkzentrum Mittelrhein GmbH

    Mayen, Mayen, 63 D-56727

  • Orthopädische Chirurgie München

    München, 81369

  • Regio Kliniken GmbH

    Pinneberg, Schleswig-Holstein, 25421

  • Sportklinik Ravensburg

    Ravensburg

  • University Hospital Regensburg

    Regensburg

Other trials in Germany

United States3 sites

  • Emory Sports Medicine Complex

    Johns Creek, Georgia, 30097

  • The MORE Foundation

    Phoenix, Arizona, 85023

  • Orthopaedic Foundation

    Stamford, Connecticut, 06905

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
Microfracture, Microfracture plus placement of Chondro-Gide® ACC
Keywords
Microfracture, Cartilage, Knee
Medical subject headings
Knee Injuries, Cartilage Diseases, Fractures, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MicrofractureProcedure or surgery

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

  • Microfracture plus placement of Chondro-Gide® ACCDevice

    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.

Study groups in NCT04537013
Study groupRoleWhat they receive
Control ArmActive comparatorPatients with small chondral lesions of the knee
Receives: Procedure: Microfracture
Investigational GroupExperimentalPatients with large chondral lesions of the knee
Receives: Device: Microfracture plus placement of Chondro-Gide® ACC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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:

    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

    Measured: 24 Months

Secondary outcomes (6)

  1. 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.

    Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

  2. 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.

    Measured: 3 months, 24 months

  3. Patient satisfaction

    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)

    Measured: 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

  4. 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

    Measured: 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

  5. 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.

    Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

  6. 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.

    Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2020
  2. Study start26 Aug 2020
  3. Primary completion25 Sep 2025
  4. Study completion29 Sep 2025

Why it stopped: The study was terminated early due to a change in business strategy at the sponsor, unrelated to any safety concerns with the medical device.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04537013
Sponsor's protocol ID
13575-237
Acronym
SECURE
Status last verified
Feb 2026
First submitted
18 Aug 2020
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Microfracture and Microfracture plus placement of Chondro-Gide® ACC in people with Knee Injuries and Cartilage Injury, run by Geistlich Pharma AG at 15 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Canada, Germany, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study was terminated early due to a change in business strategy at the sponsor, unrelated to any safety concerns with the medical device.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS (time frame: 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04537013.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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