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Erschienen in: International Orthopaedics 4/2021

12.11.2020 | Original Paper

Treatment of hallux rigidus by a novel bi-phasic aragonite-based implant: results of a two year multi-centre clinical trial

verfasst von: Matej Drobnič, Francesca Vannini, Elizaveta Kon, Oliver Dulić, Vaso Kecojević, Bogdan Andor, Nir Altschuler, Dror Robinson

Erschienen in: International Orthopaedics | Ausgabe 4/2021

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Abstract

Purpose

The two year results of a multi-centre clinical trial were examined to evaluate surgical treatment of hallux rigidus using a novel, bi-phasic, biodegradable, and cell-free aragonite-based scaffold (Agili-C™, CartiHeal Ltd, Israel).

Methods

Twenty patients with moderate-to-severe hallux rigidus were recruited. After thorough metatarsophalangeal joint (MTPJ-1) debridement, the scaffolds were implanted into the defect centre. Eight patients received concomitant osteotomy. Treatment outcome was followed clinically (Pain VAS, FAAM-ADL, FAAM-Sport, AOFAS-HMIS, maximum active range of extension ROM-EXT, and flexion ROM-FLEX), and by medical imaging, at six month intervals for two years. Adverse events were recorded throughout the study follow-up period.

Results

Significant clinical improvement over time was observed in all evaluated parameters (screening to final evaluation averages: Pain VAS 59 to 26, FAAM-ADL 57 to 77, FAAM-Sport 39 to 66, AOFAS-HMIS 51 to 81, ROM-EXT 18° to 36°), except for ROM-FLEX. Radiographs showed stable MTPJ-1 width over the two years in 17/18 cases (94%). MRI demonstrated progressive implant biodegradation, coupled with articular cartilage and subchondral bone regeneration, with a repair tissue defect fill of 75–100% in 14/17 (82%) subjects at their final visit. Revision surgery with implant removal was performed in two patients.

Conclusion

Bi-phasic, osteochondral, biodegradable, aragonite-based scaffold demonstrated positive clinical outcome and a good safety profile in the treatment of medium-to-advanced hallux rigidus. According to the medical imaging, this implant has the potential to restore the entire osteochondral unit of metatarsal head.
Literatur
13.
Zurück zum Zitat Glazebrook M, Blundell CM, O’Dowd D, Singh D, de Vries G, Le ILD, Nielsen D, Pedersen ME, Sakellariou A, Solan M, Wansbrough G, Younger ASE, Baumhauer JF, Daniels TR (2019) Midterm outcomes of a synthetic cartilage implant for the first metatarsophalangeal joint in advanced hallux rigidus. Foot Ankle Int 40:374–383. https://doi.org/10.1177/1071100718815469CrossRefPubMed Glazebrook M, Blundell CM, O’Dowd D, Singh D, de Vries G, Le ILD, Nielsen D, Pedersen ME, Sakellariou A, Solan M, Wansbrough G, Younger ASE, Baumhauer JF, Daniels TR (2019) Midterm outcomes of a synthetic cartilage implant for the first metatarsophalangeal joint in advanced hallux rigidus. Foot Ankle Int 40:374–383. https://​doi.​org/​10.​1177/​1071100718815469​CrossRefPubMed
21.
Zurück zum Zitat Drobnic M, Kolar M, Verdonk P, Vannini F, Robinson D, Shabshin N, Kon E (2020) Complex osteochondral lesions of the talus treated with a novel bi-phasic aragonite-based implant. Foot Ankle Surg Drobnic M, Kolar M, Verdonk P, Vannini F, Robinson D, Shabshin N, Kon E (2020) Complex osteochondral lesions of the talus treated with a novel bi-phasic aragonite-based implant. Foot Ankle Surg
24.
Zurück zum Zitat Coughlin MJ, Shurnas PS (2003) Hallux rigidus. Grading and long-term results of operative treatment. J Bone Joint Surg Am 85:2072–2088CrossRefPubMed Coughlin MJ, Shurnas PS (2003) Hallux rigidus. Grading and long-term results of operative treatment. J Bone Joint Surg Am 85:2072–2088CrossRefPubMed
28.
Zurück zum Zitat Mann RA, Coughlin MJ, DuVries HL (1979) Hallux rigidus: a review of the literature and a method of treatment. Clin Orthop Relat Res:57-63 Mann RA, Coughlin MJ, DuVries HL (1979) Hallux rigidus: a review of the literature and a method of treatment. Clin Orthop Relat Res:57-63
30.
44.
47.
Zurück zum Zitat Sherman TI, Kern M, Marcel J, Bulter A, McGuigan FX (2016) First metatarsophalangeal joint arthroscopy for osteochondral lesions. Arthrosc Tech 5:e513–e518CrossRefPubMedPubMedCentral Sherman TI, Kern M, Marcel J, Bulter A, McGuigan FX (2016) First metatarsophalangeal joint arthroscopy for osteochondral lesions. Arthrosc Tech 5:e513–e518CrossRefPubMedPubMedCentral
49.
Zurück zum Zitat Younger ASE, Baumhauer JF (2013) Polyvinyl alcohol hydrogel hemiarthroplasty of the great toe: technique and indications. Tech Foot Ankle Surg 12:164–169CrossRef Younger ASE, Baumhauer JF (2013) Polyvinyl alcohol hydrogel hemiarthroplasty of the great toe: technique and indications. Tech Foot Ankle Surg 12:164–169CrossRef
50.
Zurück zum Zitat Glazebrook M, Younger ASE, Daniels TR, Singh D, Blundell C, de Vries G, Le ILD, Nielsen D, Pedersen ME, Sakellariou A, Solan M, Wansbrough G, Baumhauer JF (2018) Treatment of first metatarsophalangeal joint arthritis using hemiarthroplasty with a synthetic cartilage implant or arthrodesis: a comparison of operative and recovery time. Foot Ankle Surg 24:440–447. https://doi.org/10.1016/j.fas.2017.05.002CrossRefPubMed Glazebrook M, Younger ASE, Daniels TR, Singh D, Blundell C, de Vries G, Le ILD, Nielsen D, Pedersen ME, Sakellariou A, Solan M, Wansbrough G, Baumhauer JF (2018) Treatment of first metatarsophalangeal joint arthritis using hemiarthroplasty with a synthetic cartilage implant or arthrodesis: a comparison of operative and recovery time. Foot Ankle Surg 24:440–447. https://​doi.​org/​10.​1016/​j.​fas.​2017.​05.​002CrossRefPubMed
51.
Zurück zum Zitat Baumhauer JF, Singh D, Glazebrook M, Blundell C, De Vries G, Le IL, Nielsen D, Pedersen ME, Sakellariou A, Solan M, Wansbrough G, Younger AS, Daniels T (2016) Prospective, randomized, multi-centered clinical trial assessing safety and efficacy of a synthetic cartilage implant versus first metatarsophalangeal arthrodesis in advanced hallux rigidus. Foot Ankle Int 37:457–469. https://doi.org/10.1177/1071100716635560CrossRefPubMed Baumhauer JF, Singh D, Glazebrook M, Blundell C, De Vries G, Le IL, Nielsen D, Pedersen ME, Sakellariou A, Solan M, Wansbrough G, Younger AS, Daniels T (2016) Prospective, randomized, multi-centered clinical trial assessing safety and efficacy of a synthetic cartilage implant versus first metatarsophalangeal arthrodesis in advanced hallux rigidus. Foot Ankle Int 37:457–469. https://​doi.​org/​10.​1177/​1071100716635560​CrossRefPubMed
54.
Zurück zum Zitat Bravarian B (2019) Exploring revision options for failed cartiva implant procedures. In: Podiatry today. pp. 58-61 Bravarian B (2019) Exploring revision options for failed cartiva implant procedures. In: Podiatry today. pp. 58-61
Metadaten
Titel
Treatment of hallux rigidus by a novel bi-phasic aragonite-based implant: results of a two year multi-centre clinical trial
verfasst von
Matej Drobnič
Francesca Vannini
Elizaveta Kon
Oliver Dulić
Vaso Kecojević
Bogdan Andor
Nir Altschuler
Dror Robinson
Publikationsdatum
12.11.2020
Verlag
Springer Berlin Heidelberg
Erschienen in
International Orthopaedics / Ausgabe 4/2021
Print ISSN: 0341-2695
Elektronische ISSN: 1432-5195
DOI
https://doi.org/10.1007/s00264-020-04872-8

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