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

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)

Facility	City	Region
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

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