NOVOCART 3D Treatment Following Microfracture Failure

Articular Cartilage Defect Clinical Trial

Official title:

Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03219307
• Other study ID #: AAG-G-H-1703
• Status: Recruiting
• Phase: Phase 3
• Start date: November 30, 2018
• Est. completion date: December 2028

Study information

• Verified date: May 2024
• Source: Aesculap Biologics, LLC
• Contact: Sarah Collins
• Phone: 310-948-8400
• Email: sarah.collins[@]aesculapbiologics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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

Related Conditions & MeSH terms

• Articular Cartilage Defect
• Cartilage Diseases
• Fractures, Stress

Intervention

Combination Product:
• NOVOCART 3D
Matrix associated autologous chondrocyte implant

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio
United States	Alpine Orthopaedics	North Logan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap Biologics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KOOS pain subdomain score	Comparison of pain scores from the KOOS questionnaire from baseline	24 months
Secondary	KOOS function subdomain score	Comparison of function scores from the KOOS questionnaire from baseline	24 months
Secondary	VAS pain scale	Comparison of pain from baseline	24 months
Secondary	IKDC subjective scores	Comparison of IKDC subjective scores from baseline	24 months

External Links

•   Main Clinical Study AAG-G-H-1220