NOVOCART 3D Treatment Following Microfracture Failure

Phase 3Active Not RecruitingNCT03219307

Aesculap Biologics, LLC30 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Articular Cartilage Defect

Interventions

NOVOCART 3DCOMBINATION_PRODUCT

Matrix associated autologous chondrocyte implant

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (5)

Rush University Medical Center

Chicago, Illinois, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Alpine Orthopaedics

North Logan, Utah, United States

University of Alberta

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

KOOS pain subdomain score

Comparison of pain scores from the KOOS questionnaire from baseline

Time frame: 24 months

Secondary Outcomes

KOOS function subdomain score

Comparison of function scores from the KOOS questionnaire from baseline

Time frame: 24 months

VAS pain scale

Comparison of pain from baseline

Time frame: 24 months

IKDC subjective scores

Comparison of IKDC subjective scores from baseline

Time frame: 24 months

Data from ClinicalTrials.gov

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