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Active, not recruiting Phase 3

NOVOCART 3D Treatment Following Microfracture Failure

NCT03219307 · tracked via the Priya Life Science USA tracker
Sponsor
Aesculap Biologics, LLC
Phase
Phase 3
Started
2018-11-30
Last updated
2025-03-21

Condition(s) studied

Articular Cartilage Defect

Investigational drug(s) / intervention(s)

NOVOCART 3D

NOVOCART 3D: Matrix associated autologous chondrocyte implant

Study summary

This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * participated in study AAG-G-H-1220 * identified as a microfracture failure patient * voluntary consent to participate in the study Exclusion Criteria: * other cartilage repair procedures performed on target knee * other conditions that would interfere with healing or evaluating outcomes * lesions requiring implants larger than 9cm2 * non-compliance with requirements in study AAG-G-H-1220

Primary outcome measure(s)

  • KOOS pain subdomain score — 24 months
    Comparison of pain scores from the KOOS questionnaire from baseline

Trial sites (5)

FacilityCityRegionStatus
Rush University Medical Center Chicago Illinois
Ohio State University Wexner Medical Center Columbus Ohio
Alpine Orthopaedics North Logan Utah
University of Alberta Edmonton Alberta
Dalhousie University Halifax Nova Scotia

More Aesculap Biologics, LLC trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03219307 on ClinicalTrials.gov ↗ ← All trials in the USA