NOVOCART 3D Treatment Following Microfracture Failure

Phase 3

Active, not recruiting

• Conditions: Articular Cartilage Defect
• Interventions: Combination Product: NOVOCART 3D

• Registration Number: NCT03219307
• Lead Sponsor: Aesculap Biologics, LLC

Brief 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.

Detailed Description

This study is an extension of protocol AAG-G-H-1220 wherein patients were randomized to either NOVOCART 3D or Microfracture treatment groups. This prospective single arm extension study is only open to participants of AAG-G-H-1220 who were randomized to Microfracture treatment and who failed Microfracture treatment.

Study Timeline

• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-17
• Study Start: 2018-11-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21
• Primary Completion: 2026-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NOVOCART 3D	NOVOCART 3D	Matrix associated autologous chondrocyte implant

Primary Outcome Measures

Name	Time	Method
KOOS pain subdomain score	24 months	Comparison of pain scores from the KOOS questionnaire from baseline

Secondary Outcome Measures

Name	Time	Method
IKDC subjective scores	24 months	Comparison of IKDC subjective scores from baseline
KOOS function subdomain score	24 months	Comparison of function scores from the KOOS questionnaire from baseline
VAS pain scale	24 months	Comparison of pain from baseline

Trial Locations

Locations (5)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Alpine Orthopaedics; 🇺🇸 North Logan, Utah, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Dalhousie University; 🇨🇦 Halifax, Nova Scotia, Canada