Active — Not RecruitingPhase 3

NOVOCART®3D for Treatment of Articular Cartilage of the Knee

United States233 participantsStarted 2013-12

Plain-language summary

This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Greater than 18 years old * Isolated articular cartilage lesions on the femoral condyle 2-6 cm2 * Minimum score on the KOOS questionnaire Exclusion Criteria: * Instability of the knee joint * Arthritis * Autoimmune disease * Immune suppression * Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline) * Bone disease * Any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.

What they're measuring

Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain

Timeframe: 24 months post treatment

Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain

Timeframe: 24 months post treatment

Trial details

NCT IDNCT01957722

SponsorAesculap Biologics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Articular Cartilage of the Femoral Condyle Between 2-6cm2 trials