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NCT Number: NCT03219307

NOVOCART 3D Treatment Following Microfracture Failure

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Articular Cartilage Defect

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NOVOCART 3D

Combination Product

Matrix associated autologous chondrocyte implant

Primary outcomes

  1. KOOS pain subdomain score

    Time frame: 24 months

    Comparison of pain scores from the KOOS questionnaire from baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Aesculap Biologics, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2029
First posted
Jul 17, 2017
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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