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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Aesculap Biologics, LLC
Sponsor:
Information provided by (Responsible Party):
Aesculap Biologics, LLC
ClinicalTrials.gov Identifier:
NCT01957722
First received: September 17, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

This study is to 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.


Condition Intervention Phase
Articular Cartilage of the Femoral Condyle Between 2-6cm2
Procedure: microfracture
Biological: NOVOCART 3D
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Aesculap Biologics, LLC:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 months post treatment ] [ Designated as safety issue: Yes ]
    As measured by change in score from Baseline in KOOS score

  • Function [ Time Frame: 24 months post treatment ] [ Designated as safety issue: No ]
    As measured by change in score from Baseline in KOOS score


Estimated Enrollment: 233
Study Start Date: January 2014
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NOVOCART 3D
Scaffold assisted autologous chondrocyte Implant
Biological: NOVOCART 3D
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957722

Locations
United States, California
CORE Orthopedic Recruiting
Encinitas, California, United States, 92024
Contact: Farouk Awad    760-943-6710 ext 162    fawad@coreorthopaedic.com   
Principal Investigator: Gregory Loren, MD         
Kerlan Jobe Orthopedic Foundation Recruiting
Los Angeles, California, United States, 90045
Contact: Laura Goldsmith    310-665-7200 ext 6255    laura.goldsmith@kerlanjobe.com   
Principal Investigator: Ralph Gambardella         
United States, District of Columbia
The George Washington University Hospital Recruiting
Washington, District of Columbia, United States, 20037
Contact: S Tam       stam@mfa.gwu.edu   
Principal Investigator: Rajeev Padrinath         
United States, Florida
Florida Orthopaedic Institute 13020 N. Telecom Pkwy Tampa, FL 33637 Recruiting
Tampa, Florida, United States, 33637
Contact: Rachel Clark       rclark@foreonline.org   
Principal Investigator: Seth Gasser         
United States, Georgia
Glynn Brunswick Memorial Authority/ SE Georgia Health System Recruiting
Brunswick, Georgia, United States, 31525
Contact: Gwen Gratto-Cox    912-262-9961 ext 122    ggratto@sghs.org   
Principal Investigator: Melvin Deese         
United States, Illinois
Northshore University Healthsystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Diana Walker    847-570-3116    dwalker3@northshore.org   
Principal Investigator: Jason Koh, MD         
SIU School of Medicine Recruiting
Springfield, Illinois, United States, 62794
Contact: Julie Bullard    217-545-7879    jbullard@siumed.edu   
Principal Investigator: Saadiq El-Amin, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Jennifer Howard       j.s.howard@uky.edu   
Principal Investigator: Christian Lattermann         
United States, Pennsylvania
University Orthopedics Center Recruiting
Altoona, Pennsylvania, United States, 16602
Contact: Robin Stern    814-949-4050    rstern@uoc.com   
Principal Investigator: William Tyndall         
St Luke's Health System Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Denise Tarsi    484-526-7825    Denise.Tarsi@sluhn.org   
Principal Investigator: Gregory Carolan, MD         
Temple University Hospital, Dept. of Orthopaedic Surgery Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Joanne Donnelly    215-707-9221    Joanne.Donnelly@tuhs.temple.edu   
Principal Investigator: J. Milo Sewards         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Joe Hart    434-924-6187      
Principal Investigator: David Diduch         
Orthopaedic Center of Central Virginia, Inc Recruiting
Lynchburg, Virginia, United States, 24501
Contact: Brenda Davis    434-485-8529    Brenda.Davis@OCCVA.com   
Principal Investigator: Gautham Gondi, MD         
Advanced Orthopedics Recruiting
Richmond, Virginia, United States, 23294
Contact: Lisa Thorpe    804-527-6803    lthorp@advancedortho.me   
Principal Investigator: Kenneth Zaslav         
Sponsors and Collaborators
Aesculap Biologics, LLC
  More Information

No publications provided

Responsible Party: Aesculap Biologics, LLC
ClinicalTrials.gov Identifier: NCT01957722     History of Changes
Other Study ID Numbers: AAG-G-H-1220
Study First Received: September 17, 2013
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014