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Knee Surg Sports Traumatol Arthrosc. 2018 Sep;26(9):2704-2715. doi: 10.1007/s00167-017-4707-3. Epub 2017 Sep 14.

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

Author information

1
Humanitas University Department of Biomedical Sciences - Humanitas Clinical and Research Center, Milan, Italy.
2
NABI Laboratory, Rizzoli Orthopaedic Institute, Via Di Barbiano 1/10, 40136, Bologna, Italy. g.filardo@biomec.ior.it.
3
Department of Orthopaedics, Cartilaginous research unit, Goteborg University, Kungsbacka Hospital, Kungsbacka, Sweden.
4
Radiology, Rizzoli Orthopaedic Institute, Bologna, Italy.
5
Dipartimento di Ortopedia, Ospedale Sacro Cuore Don Calabria di Negrar, Verona, Italy.
6
Department of orthopaedic surgery, Ullevål Hospital, Oslo University, Oslo, Norway.
7
Ordinationszentrum Döbling, Vienna, Austria.
8
Department of orthopaedic surgery and traumatology, Freiburg University Hospital, Freiburg Im Breisgau, Germany.
9
Department of traumatology, Medical University of Vienna, Vienna, Austria.
10
Division of Exercise Science and Sports Medicine, Faculty of Health Sciences, The University of Cape Town, Cape Town, South Africa.
11
Antwerp Orthopaedic Center, Monica Hospitals, Stevenslei, Deurne, Belgium.
12
Université Libre de Bruxelles, Brussels, Belgium.
13
Department of orthopaedic surgery, Ghent University Hospital, Ghent, Belgium.
14
Sport Science Orthopaedic Clinic, Sport Science Institute of South Africa Newlands, Cape Town, South Africa.
15
Wojewódzki Szpital Chirurgii Urazowej, II Oddział Urazowo-Ortopedyczny, Piekary Śląskie, Polen.

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.

KEYWORDS:

Bone marrow stimulation; Cartilage; Knee; Osteochondral; Scaffold

PMID:
28913600
PMCID:
PMC6105149
DOI:
10.1007/s00167-017-4707-3
[Indexed for MEDLINE]
Free PMC Article

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