A Prospective, Randomized, Open-Label, Multicenter, Phase III Noninferiority Trial to Compare the Clinical Efficacy of Matrix-Associated Autologous Chondrocyte Implantation With Spheroid Technology Versus Arthroscopic Microfracture for Cartilage Defects of the Knee.

ABSTRACT:

Background

Autologous chondrocyte implantation (ACI) and microfracture are established treatments for large, full-thickness cartilage defects, but there is still a need to expand the clinical and health economic knowledge of these procedures.

Purpose

To confirm the noninferiority of ACI compared with microfracture.

Study design

Randomized controlled trial; Level of evidence, 2.

Methods

Patients were randomized to be treated with matrix-associated ACI using spheroid technology (n = 52) or microfracture (n = 50). Both procedures followed standard methods. Patients were assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS), MOCART (magnetic resonance observation of cartilage repair tissue) scoring system, Bern score, modified Lysholm score, Internati

SUBMITTER: Niemeyer P 

PROVIDER: S-EPMC6620731 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature