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NCT Number: NCT01957722

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Articular Cartilage of the Femoral Condyle Between 2-6cm2

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Microfracture

Procedure

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

NOVOCART 3D

Biological

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

Primary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain

    Time frame: 24 months post treatment

    As measured by a change in KOOS (pain subdomain) score at 24 months from baseline

  2. Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain

    Time frame: 24 months post treatment

    As measured by a change in KOOS score (activity of daily living subdomain) at 24 months from baseline

Sponsors and collaborators

Lead sponsor

Aesculap Biologics, LLC

Industry

Registry information

Official study title

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

Acronym: N3D

Important dates

Study start
2013
Primary completion
2025
Study completion
2027
First posted
Oct 8, 2013
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.