NCT01957722

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

A Phase 3, Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART 3D Compared ot Microfracture in the Treatment of Articular Cartilage Defects

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Aesculap Biologics, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects with articular knee defects will be randomized to receive either Microfracture or NOVOCART 3D. Subjects will be followed for five years in total and will be evaluated for safety and efficacy.

Conditions

• Articular Cartilage of the Femoral Condyle Between 2-6cm2

Interventions

Type	Name	Description
PROCEDURE	Microfracture	Surgical procedure which creates a marrow clot in the prepare cartilage defect.
BIOLOGICAL	NOVOCART 3D	combination product- biologic (autologous chondrocytes) /device (scaffold) implant

Timeline

• Start date: 2013-12-01
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2013-10-08
• Last updated: 2025-03-21

Locations

35 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study