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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01957722

Acronym

N3D

Enrollment

233

Registered

2013-10-08

Start date

2013-12-31

Completion date

2027-12-31

Last updated

2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Articular Cartilage of the Femoral Condyle Between 2-6cm2

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.

Interventions

PROCEDUREMicrofracture

Surgical procedure which creates a marrow clot in the prepare cartilage defect.

BIOLOGICALNOVOCART 3D

combination product- biologic (autologous chondrocytes) /device (scaffold) implant

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026