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NOVOCART 3D Treatment Following Microfracture Failure

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ClinicalTrials.gov Identifier: NCT03219307
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Aesculap Biologics, LLC

Brief Summary:
This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.

Condition or disease Intervention/treatment Phase
Articular Cartilage Defect Combination Product: NOVOCART 3D Phase 3

Detailed Description:
This study is an extension of protocol AAG-G-H-1220 wherein patients were randomized to either NOVOCART 3D or Microfracture treatment groups. This prospective single arm extension study is only open to participants of AAG-G-H-1220 who were randomized to Microfracture treatment and who failed Microfracture treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: NOVOCART 3D
Matrix associated autologous chondrocyte implant
Combination Product: NOVOCART 3D
Matrix associated autologous chondrocyte implant




Primary Outcome Measures :
  1. KOOS pain subdomain score [ Time Frame: 24 months ]
    Comparison of pain scores from the KOOS questionnaire from baseline


Secondary Outcome Measures :
  1. KOOS function subdomain score [ Time Frame: 24 months ]
    Comparison of function scores from the KOOS questionnaire from baseline

  2. VAS pain scale [ Time Frame: 24 months ]
    Comparison of pain from baseline

  3. IKDC subjective scores [ Time Frame: 24 months ]
    Comparison of IKDC subjective scores from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • participated in study AAG-G-H-1220
  • identified as a microfracture failure patient
  • voluntary consent to participate in the study

Exclusion Criteria:

  • other cartilage repair procedures performed on target knee
  • other conditions that would interfere with healing or evaluating outcomes
  • lesions requiring implants larger than 9cm2
  • non-compliance with requirements in study AAG-G-H-1220

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): NCT03219307


Contacts
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Contact: Jennifer Sisler, BSN, RN 610-984-4218 jennifer.sisler@aesculapbiologics.com
Contact: Sarah Collins 310-948-8400 sarah.collins@aesculapbiologics.com

Locations
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United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43202
Contact: Courtney Wright    614-293-2410      
Principal Investigator: David Flanigan, MD         
United States, Utah
Alpine Orthopaedics Recruiting
North Logan, Utah, United States, 84341
Contact    435-774-8512      
Principal Investigator: Brad Larson, MD         
Sponsors and Collaborators
Aesculap Biologics, LLC
Investigators
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Study Director: Robert Spiro, PhD Aesculap Biologics

Additional Information:
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Responsible Party: Aesculap Biologics, LLC
ClinicalTrials.gov Identifier: NCT03219307     History of Changes
Other Study ID Numbers: AAG-G-H-1703
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Aesculap Biologics, LLC:
cartilage repair
cartilage regeneration
cartilage reconstruction
cartilage restoration
autologous chondrocyte implantation
matrix associated chondrocyte implantation
Additional relevant MeSH terms:
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Cartilage Diseases
Fractures, Stress
Fractures, Bone
Wounds and Injuries
Musculoskeletal Diseases
Connective Tissue Diseases