NOVOCART 3D Treatment Following Microfracture Failure

Aesculap

Status and phase: Active, not recruiting; Phase 3

Conditions: Articular Cartilage Defect

Treatments: Combination Product: NOVOCART 3D

Study type: Interventional

Funder types: Industry

Identifiers

NCT03219307

AAG-G-H-1703

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

NOVOCART 3D

Experimental group

Description:

Matrix associated autologous chondrocyte implant

Treatment:

Combination Product: NOVOCART 3D