NOVOCART®3D for Treatment of Articular Cartilage of the Knee (N3D)

March 1, 2022 updated by: Aesculap Biologics, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

233

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R3
        • Recruiting
        • University of Alberta
        • Contact:
        • Principal Investigator:
          • Mark Sommerfeldt, MD
    • British Columbia
      • Surrey, British Columbia, Canada, V3T 0H1
        • Recruiting
        • Simon Fraser Health Authority
        • Contact:
        • Principal Investigator:
          • Robert McCormack, MD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2E1
        • Recruiting
        • Dalhousie University
        • Contact:
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • St. Josephs Healthcare
        • Contact:
      • Kingston, Ontario, Canada, K7L 3N6
        • Withdrawn
        • Queens University
      • London, Ontario, Canada, N6C 2R5
        • Recruiting
        • Lawson Health Research Institute
        • Principal Investigator:
          • Alan Getgood, MD
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Withdrawn
        • The Core Institute
    • California
      • Encinitas, California, United States, 92024
        • Withdrawn
        • Core Orthopedic
      • La Mesa, California, United States, 91942
        • Recruiting
        • Grossmont Orthopaedic Group
        • Principal Investigator:
          • Scott Hacker, MD
        • Contact:
      • Los Angeles, California, United States, 90095
      • Redwood City, California, United States, 94063
      • Sacramento, California, United States, 95816
        • Withdrawn
        • University of California Davis
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Orthopaedic Institute
        • Contact:
        • Principal Investigator:
          • C Benjamin Ma, MD
    • Colorado
      • Denver, Colorado, United States, 80220
        • Withdrawn
        • Va Eastern Colorado Health System
      • Denver, Colorado, United States, 80222
        • Recruiting
        • CU Sports Medicine
        • Contact:
        • Principal Investigator:
          • Rachel Frank, MD
      • Steamboat Springs, Colorado, United States, 80487
        • Recruiting
        • Yampa Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Alexander Meininger, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Withdrawn
        • George Washington University Hospital
    • Florida
      • Boca Raton, Florida, United States, 33433
        • Withdrawn
        • Tenet Florida Physician Services
      • Tampa, Florida, United States, 33637
        • Withdrawn
        • Florida Orthopaedic Institute
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Paley Orthopedic and Spine Institute
        • Contact:
        • Principal Investigator:
          • Tom Minas, MD
    • Georgia
      • Brunswick, Georgia, United States, 31525
        • Withdrawn
        • Glynn Brunswick Memorial Authority
    • Idaho
      • Boise, Idaho, United States, 83702
        • Recruiting
        • St. Lukes Intermountain Research Center
        • Contact:
        • Principal Investigator:
          • James Beckmann, MD
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Alphonsus Medical Group
        • Contact:
        • Principal Investigator:
          • Andrew Curran, CO
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Northshore University Health System
        • Contact:
        • Principal Investigator:
          • Jason Koh, MD
      • Springfield, Illinois, United States, 62794
        • Withdrawn
        • SIU School of Medicine
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Withdrawn
        • University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Maryland
      • Salisbury, Maryland, United States, 21804
        • Withdrawn
        • Peninsula Orthopaedic Associates
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • John Grant, MD
        • Contact:
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Recruiting
        • TRIA Orthopedic Center
        • Contact:
        • Principal Investigator:
          • Marc Tompkins, MD
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Aaron Krych, MD
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri Healthcare
        • Contact:
        • Principal Investigator:
          • Richard Ma, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Withdrawn
        • University of New Mexico
    • New York
      • New York, New York, United States, 10128
        • Recruiting
        • Plancher Orthopaedics & Sports Medicine
        • Contact:
      • New York, New York, United States, 10029
        • Active, not recruiting
        • Mount Sinai Faculty Practice Associates
      • Port Jefferson, New York, United States, 11777
        • Withdrawn
        • Long Island Bone and Joint Llp
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Withdrawn
        • Duke University
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • Ohio State University Sports Medicine
        • Principal Investigator:
          • David Flanigan, MD
        • Contact:
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Tulsa Bone and Joint Associates
        • Contact:
        • Principal Investigator:
          • John Balbas, MD
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Withdrawn
        • Orthopaedic Associates of Allentown Ltd.
      • Altoona, Pennsylvania, United States, 16602
        • Withdrawn
        • University Orthopedics Center
      • Bethlehem, Pennsylvania, United States, 18015
        • Active, not recruiting
        • St. Luke's University Health Network
      • Hershey, Pennsylvania, United States, 17033
        • Withdrawn
        • Penn State Hershey Medical Center
      • Newtown Square, Pennsylvania, United States, 19073
        • Withdrawn
        • Rothman Institute
      • Philadelphia, Pennsylvania, United States, 19140
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • Clinical Research Solutions
        • Principal Investigator:
          • Jason Hutchison, MD
        • Contact:
        • Contact:
    • Texas
      • Houston, Texas, United States, 77036
        • Withdrawn
        • Mercury Clinical Research
    • Utah
      • North Logan, Utah, United States, 84341
        • Recruiting
        • Alpine Orthopaedics
        • Contact:
        • Principal Investigator:
          • Brad Larson, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Lynchburg, Virginia, United States, 24501
        • Withdrawn
        • The Orthopaedic Center of Central Virginia Inc.
      • Richmond, Virginia, United States, 23294
      • Virginia Beach, Virginia, United States, 23462
        • Recruiting
        • Jordan-young Institute
        • Contact:
        • Principal Investigator:
          • Kevin Bonner, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NOVOCART 3D
Scaffold assisted autologous chondrocyte Implant
Biological: NOVOCART 3D
combination product- biologic (autologous chondrocytes) /device (scaffold) implant
Active Comparator: Microfracture
considered a typical treatment for articular cartilage repair
Procedure: Microfracture
Surgical procedure which creates a marrow clot in the prepare cartilage defect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months post treatment
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
24 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap Biologics, LLC

Investigators

  • Study Director: Robert Spiro, PhD, Aesculap Biologics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • AAG-G-H-1220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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