NOVOCART 3D Treatment Following Microfracture Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2029-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Articular Cartilage Defect

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NOVOCART 3D

Matrix associated autologous chondrocyte implant

Group Type EXPERIMENTAL

NOVOCART 3D

Intervention Type COMBINATION_PRODUCT

Matrix associated autologous chondrocyte implant

Interventions

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NOVOCART 3D

Matrix associated autologous chondrocyte implant

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No