NOVOCART 3D Treatment Following Microfracture Failure

March 1, 2022 updated by: Aesculap Biologics, LLC

Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43202
        • Recruiting
        • Ohio State University
        • Principal Investigator:
          • David Flanigan, MD
        • Contact:
          • Courtney Wright
          • Phone Number: 614-293-2410
    • Utah
      • North Logan, Utah, United States, 84341
        • Recruiting
        • Alpine Orthopaedics
        • Principal Investigator:
          • Brad Larson, MD
        • Contact:
          • Phone Number: 435-774-8512

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NOVOCART 3D
Matrix associated autologous chondrocyte implant
Combination product: NOVOCART 3D
Matrix associated autologous chondrocyte implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS pain subdomain score
Time Frame: 24 months
Comparison of pain scores from the KOOS questionnaire from baseline
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS function subdomain score
Time Frame: 24 months
Comparison of function scores from the KOOS questionnaire from baseline
24 months
VAS pain scale
Time Frame: 24 months
Comparison of pain from baseline
24 months
IKDC subjective scores
Time Frame: 24 months
Comparison of IKDC subjective scores from baseline
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap Biologics, LLC

Investigators

  • Study Director: Robert Spiro, PhD, Aesculap Biologics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2018

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2028

Study Registration Dates

First Submitted

July 13, 2017

First Submitted That Met QC Criteria

July 13, 2017

First Posted (Actual)

July 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-G-H-1703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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