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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 : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Aesculap Biologics, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Articular Cartilage of the Femoral Condyle Between 2-6cm2 Procedure: Microfracture Biological: NOVOCART 3D Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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
Actual Study Start Date : December 2013
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957722


Contacts
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Contact: Sarah Collins 310-948-8400 sarah.collins@aesculapbiologics.com

Locations
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Sponsors and Collaborators
Aesculap Biologics, LLC
Investigators
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Study Director: Robert Spiro, PhD Aesculap Biologics
More Information
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Responsible Party: Aesculap Biologics, LLC
ClinicalTrials.gov Identifier: NCT01957722    
Other Study ID Numbers: AAG-G-H-1220
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No