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A multilayer biomaterial for osteochondral regeneration shows superiority vs microfractures for the treatment of osteochondral lesions in a multicentre randomized trial at 2 years

Journal article
Authors E. Kon
G. Filardo
Mats Brittberg
M. Busacca
V. Condello
L. Engebretsen
S. Marlovits
P. Niemeyer
P. Platzer
M. Posthumus
P. Verdonk
R. Verdonk
J. Victor
W. van der Merwe
W. Widuchowski
C. Zorzi
M. Marcacci
Published in Knee Surgery Sports Traumatology Arthroscopy
Volume 26
Issue 9
Pages 2704-2715
ISSN 0942-2056
Publication year 2018
Published at Institute of Clinical Sciences
Pages 2704-2715
Language en
Links dx.doi.org/10.1007/s00167-017-4707-...
Keywords Osteochondral, Cartilage, Scaffold, Knee, Bone marrow stimulation, articular-cartilage repair, 2-year follow-up, biomimetic scaffold, unicompartmental osteoarthritis, knee, tissue, implantation, defects, matrix, Orthopedics, Sport Sciences, Surgery
Subject categories Orthopedics

Abstract

Purpose The increasing awareness on the role of subchondral bone in the etiopathology of articular surface lesions led to the development of osteochondral scaffolds. While safety and promising results have been suggested, there are no trials proving the real potential of the osteochondral regenerative approach. Aim was to assess the benefit provided by a nanostructured collagen-hydroxyapatite (coll-HA) multilayer scaffold for the treatment of chondral and osteochondral knee lesions. Methods In this multicentre randomized controlled clinical trial, 100 patients affected by symptomatic chondral and osteochondral lesions were treated and evaluated for up to 2 years (51 study group and 49 control group). A biomimetic coll-HA scaffold was studied, and bone marrow stimulation (BMS) was used as reference intervention. Primary efficacy measurement was IKDC subjective score at 2 years. Secondary efficacy measurements were: KOOS, IKDC Knee Examination Form, Tegner and VAS Pain scores evaluated at 6, 12 and 24 months. Tissue regeneration was evaluated with MRI MOCART scoring system at 6, 12 and 24 months. An external independent agency was involved to ensure data correctness and objectiveness. Results A statistically significant improvement of all clinical scores was obtained from basal evaluation to 2-year follow-up in both groups, although no overall statistically significant differences were detected between the two treatments. Conversely, the subgroup of patients affected by deep osteochondral lesions (i.e. Outerbridge grade IV and OCD) showed a statistically significant better IKDC subjective outcome (+12.4 points, p = 0.036) in the coll-HA group. Statistically significant better results were also found for another challenging group: sport active patients (+16.0, p = 0.027). Severe adverse events related to treatment were documented only in three patients in the coll-HA group and in one in the BMS group. The MOCART score showed no statistical difference between the two groups. Conclusions This study highlighted the safety and potential of a biomimetic implant. While no statistically significant differences were found compared to BMS for chondral lesions, this procedure can be considered a suitable option for the treatment of osteochondral lesions.

Page Manager: Webmaster|Last update: 9/11/2012
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