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

Phase 3

Active, not recruiting

• Conditions: Articular Cartilage of the Femoral Condyle Between 2-6cm2
• Interventions: Procedure: Microfracture; Biological: NOVOCART 3D

• Registration Number: NCT01957722
• Lead Sponsor: Aesculap Biologics, LLC

Brief 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.

Study Timeline

• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Study Start: 2013-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

• Greater than 18 years old
• Isolated articular cartilage lesions on the femoral condyle 2-6 cm2
• Minimum score on the KOOS questionnaire

Exclusion Criteria

• Instability of the knee joint
• Arthritis
• Autoimmune disease
• Immune suppression
• Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline)
• Bone disease
• Any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microfracture	Microfracture	considered a typical treatment for articular cartilage repair
NOVOCART 3D	NOVOCART 3D	Scaffold assisted autologous chondrocyte Implant

Primary Outcome Measures

Name	Time	Method
Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain	24 months post treatment	As measured by a change in KOOS (pain subdomain) score at 24 months from baseline
Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain	24 months post treatment	As measured by a change in KOOS score (activity of daily living subdomain) at 24 months from baseline

Trial Locations

Locations (35)

Grossmont Orthopaedic Medical Group; 🇺🇸 La Mesa, California, United States

UCLA; 🇺🇸 Los Angeles, California, United States

Stanford Medicine; 🇺🇸 Redwood, California, United States

Cu Sports Medicine; 🇺🇸 Denver, Colorado, United States

Yampa Valley Medical Center; 🇺🇸 Steamboat Springs, Colorado, United States

Tenet Florida Physician Services; 🇺🇸 Boca Raton, Florida, United States

Paley Orthopedic and Spine Institute; 🇺🇸 West Palm Beach, Florida, United States

Saint Alphonsus Medical Group; 🇺🇸 Meridian, Idaho, United States

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

Northshore University Health System; 🇺🇸 Evanston, Illinois, United States

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