Fiber-reinforced fixation implant for proximal interphalangeal joint arthrodesis shows advanced implant bio-integration at 2-year follow-up.
Arthrodesis
Bio-integration
Continuous mineral fibers
Degradation
Fusion
Hammertoe
Magnetic Resonance Imaging (MRI)
Journal
Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons
ISSN: 1460-9584
Titre abrégé: Foot Ankle Surg
Pays: France
ID NLM: 9609647
Informations de publication
Date de publication:
Dec 2022
Dec 2022
Historique:
received:
29
03
2022
revised:
16
06
2022
accepted:
21
06
2022
pubmed:
1
7
2022
medline:
15
12
2022
entrez:
30
6
2022
Statut:
ppublish
Résumé
A bio-integrative fiber-reinforced implant (OSSIOfiber® Hammertoe Fixation Implant, OSSIO Ltd., Caesarea, Israel) for proximal interphalangeal joint (PIPJ) correction-arthrodesis showed partial bio-integration at 1-year follow-up (1FU) in a previous study. The study was prolonged to assess the bio-integration at 2-year-follow-up (2FU). Twenty-four patients with proximal interphalangeal joint (PIPJ) correction-arthrodesis using the fiber-reinforced implant and analysed at 1FU, completed 2FU. Follow-up included clinical examination, patient reported outcomes, radiographs, MRI and bio-integration scoring. Results were compared between the 1FU and 2FU (paired t-test). Radiographs confirmed fusion in 96 % (n = 23) at 2FU (1FU, 92 % (n = 22)). Implant was no longer visible in 21 % (n = 5), partially visible in 33 % (n = 8), and fully visible in 46 % (n = 11)(1FU, fully visible 100 % (n = 24)). The border between implant and surrounding bone was scored not visible in 88 % (n = 21) and partially visible in 12 % (n = 3) (1FU, border partially visible 100 % (n = 24)). There were no cyst formation or fluid accumulation findings 1FU/2FU. Mild bone edema was detected in 4 % (n = 1) (1FU, 29 % (n = 7)). None of the edema findings were considered as adverse implant related. The mean bio-integration score was 9.71 ± 0.69 at 2FU (1FU, 7.71 ± 0.46). The parameters of border between implant and bone and bone edema further improved at the 2FU compared to the 1FU, total bio-integration score was also higher at 2FU than 1FU (each p < 0.05). This study demonstrates 96 % PIPJ fusion rate and increased bio-integration from 1FU to 2FU, reaching advanced bio-integration of the fiber-reinforced implant at 2FU.
Sections du résumé
BACKGROUND
BACKGROUND
A bio-integrative fiber-reinforced implant (OSSIOfiber® Hammertoe Fixation Implant, OSSIO Ltd., Caesarea, Israel) for proximal interphalangeal joint (PIPJ) correction-arthrodesis showed partial bio-integration at 1-year follow-up (1FU) in a previous study. The study was prolonged to assess the bio-integration at 2-year-follow-up (2FU).
METHODS
METHODS
Twenty-four patients with proximal interphalangeal joint (PIPJ) correction-arthrodesis using the fiber-reinforced implant and analysed at 1FU, completed 2FU. Follow-up included clinical examination, patient reported outcomes, radiographs, MRI and bio-integration scoring. Results were compared between the 1FU and 2FU (paired t-test).
RESULTS
RESULTS
Radiographs confirmed fusion in 96 % (n = 23) at 2FU (1FU, 92 % (n = 22)). Implant was no longer visible in 21 % (n = 5), partially visible in 33 % (n = 8), and fully visible in 46 % (n = 11)(1FU, fully visible 100 % (n = 24)). The border between implant and surrounding bone was scored not visible in 88 % (n = 21) and partially visible in 12 % (n = 3) (1FU, border partially visible 100 % (n = 24)). There were no cyst formation or fluid accumulation findings 1FU/2FU. Mild bone edema was detected in 4 % (n = 1) (1FU, 29 % (n = 7)). None of the edema findings were considered as adverse implant related. The mean bio-integration score was 9.71 ± 0.69 at 2FU (1FU, 7.71 ± 0.46). The parameters of border between implant and bone and bone edema further improved at the 2FU compared to the 1FU, total bio-integration score was also higher at 2FU than 1FU (each p < 0.05).
CONCLUSIONS
CONCLUSIONS
This study demonstrates 96 % PIPJ fusion rate and increased bio-integration from 1FU to 2FU, reaching advanced bio-integration of the fiber-reinforced implant at 2FU.
Identifiants
pubmed: 35773179
pii: S1268-7731(22)00117-5
doi: 10.1016/j.fas.2022.06.013
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1293-1299Informations de copyright
Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest I declare the following potential conflicts of interest. Luke D. Cichinelli, Martinus Richter and Stuart Miller are consultants of Ossio. Martinus Richter is consultant of Curvebeam, Geistlich, Intercus, and Implants International, proprietor of R-Innovation, and shareholder of Curvebeam.