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Knee Surgery, Sports Traumatology, Arthroscopy
Published in: Knee Surgery, Sports Traumatology, Arthroscopy 9/2018

Open Access 01-09-2018 | Knee

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

Authors: Elizaveta Kon, Giuseppe Filardo, Mats Brittberg, Maurizio Busacca, Vincenzo Condello, Lars Engebretsen, Stefan Marlovits, Philipp Niemeyer, Patrik Platzer, Michael Posthumus, Peter Verdonk, Renè Verdonk, Jan Victor, Willem van der Merwe, Wojciech Widuchowski, Claudio Zorzi, Maurilio Marcacci

Published in: Knee Surgery, Sports Traumatology, Arthroscopy | Issue 9/2018

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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.

Level of evidence

I.
Appendix
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Metadata
Title
A multilayer biomaterial for osteochondral regeneration shows superiority vs microfractures for the treatment of osteochondral lesions in a multicentre randomized trial at 2 years
Authors
Elizaveta Kon
Giuseppe Filardo
Mats Brittberg
Maurizio Busacca
Vincenzo Condello
Lars Engebretsen
Stefan Marlovits
Philipp Niemeyer
Patrik Platzer
Michael Posthumus
Peter Verdonk
Renè Verdonk
Jan Victor
Willem van der Merwe
Wojciech Widuchowski
Claudio Zorzi
Maurilio Marcacci
Publication date
01-09-2018
Publisher
Springer Berlin Heidelberg
Published in
Knee Surgery, Sports Traumatology, Arthroscopy / Issue 9/2018
Print ISSN: 0942-2056
Electronic ISSN: 1433-7347
DOI
https://doi.org/10.1007/s00167-017-4707-3

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