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

Stopped early · Not applicable

Conditions studied: Knee Injuries, Cartilage Injury, Cartilage Disease, Knee Discomfort

In brief

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.

Key facts

Study ID

NCT04537013

Run by

Geistlich Pharma AG

People needed

82

Starts

2020-08-26

Expected to finish

2025-09-29

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The MORE Foundation — Phoenix, Arizona, United States
• Orthopaedic Foundation — Stamford, Connecticut, United States
• Emory Sports Medicine Complex — Johns Creek, Georgia, United States
• Fraser Orthopaedic Institute — New Westminster, British Columbia, Canada
• University of Calgary — Calgary, CGY, Canada
• Hamilton Health Sciences — Hamilton, Ontario, Canada
• St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada
• Sunnybrook Research Institute (SRI) — Toronto, Ontario, Canada
• University of Toronto Orthopaedics — Toronto, TOR, Canada
• Gelenkzentrum Mittelrhein GmbH — Mayen, Mayen, Germany
• Regio Kliniken GmbH — Pinneberg, Schleswig-Holstein, Germany
• Universitätsklinikum Schleswig Holstein Campus Lübeck — Lübeck, Germany
• Orthopädische Chirurgie München — München, Germany
• Sportklinik Ravensburg — Ravensburg, Germany
• University Hospital Regensburg — Regensburg, Germany

Full record on ClinicalTrials.gov

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