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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Aesculap Biologics, LLC
Sponsor:
Information provided by (Responsible Party):
Aesculap Biologics, LLC
ClinicalTrials.gov Identifier:
NCT01957722
First received: September 17, 2013
Last updated: March 17, 2016
Last verified: March 2016
  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
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.

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 65 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

Contacts
Contact: Cathy Dawson 610-894-9440 cathy.dawson@aesculap.com

  Show 27 Study Locations
Sponsors and Collaborators
Aesculap Biologics, LLC
  More Information

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: March 17, 2016
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 30, 2016