Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01957722
Recruitment Status : Recruiting
First Posted : October 8, 2013
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Aesculap Biologics, LLC

Tracking Information
First Submitted Date  ICMJE September 17, 2013
First Posted Date  ICMJE October 8, 2013
Last Update Posted Date October 24, 2019
Actual Study Start Date  ICMJE December 2013
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
  • Pain [ Time Frame: 24 months post treatment ]
    As measured by change in score from Baseline in KOOS score
  • Function [ Time Frame: 24 months post treatment ]
    As measured by change in score from Baseline in KOOS score
Change History Complete list of historical versions of study NCT01957722 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NOVOCART®3D for Treatment of Articular Cartilage of the Knee
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Articular Cartilage of the Femoral Condyle Between 2-6cm2
Intervention  ICMJE
  • Procedure: Microfracture
    Surgical procedure which creates a marrow clot in the prepare cartilage defect.
  • Biological: NOVOCART 3D
    combination product- biologic (autologous chondrocytes) /device (scaffold) implant
Study Arms  ICMJE
  • Experimental: NOVOCART 3D
    Scaffold assisted autologous chondrocyte Implant
    Intervention: Biological: NOVOCART 3D
  • Active Comparator: Microfracture
    considered a typical treatment for articular cartilage repair
    Intervention: Procedure: Microfracture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2013)
233
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2026
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alyse Borelli, MPH, CCRP 610-984-9426 alyse.borelli@aesculapbiologics.com
Contact: Sarah Collins 310-948-8400 sarah.collins@aesculapbiologics.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01957722
Other Study ID Numbers  ICMJE AAG-G-H-1220
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aesculap Biologics, LLC
Study Sponsor  ICMJE Aesculap Biologics, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Spiro, PhD Aesculap Biologics
PRS Account Aesculap Biologics, LLC
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP