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

  • STATUS
    Recruiting
  • End date
    Aug 25, 2025
  • participants needed
    234
  • sponsor
    Geistlich Pharma AG
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Updated on 25 March 2022
See if I qualify
arthroscopy
Accepts healthy volunteers

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.

Details
Condition Knee Injuries, Cartilage Injury, Cartilage Disease, Knee Discomfort
Treatment Microfracture, Microfracture plus placement of Chondro-Gide® ACC
Clinical Study IdentifierNCT04537013
SponsorGeistlich Pharma AG
Last Modified on25 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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