Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.

<h4>Background</h4>In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to understand device use and outcomes since this implant entered clinical practice in order to establish increme...

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Autores principales:	Paul Welford, Natalie S Blencowe, Emily Pardington, Conor S Jones, Jane M Blazeby, Barry G Main
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/670483f50c004e7182cc80a7727455c9
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spelling	oai:doaj.org-article:670483f50c004e7182cc80a7727455c92021-12-02T20:16:48ZSystematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.1932-620310.1371/journal.pone.0257497https://doaj.org/article/670483f50c004e7182cc80a7727455c92021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0257497https://doaj.org/toc/1932-6203<h4>Background</h4>In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to understand device use and outcomes since this implant entered clinical practice in order to establish incremental evidence, appropriate study design and reporting. This systematic review summarised and appraised studies reporting pyrocarbon proximal interphalangeal joint arthroplasty.<h4>Methods</h4>Systematic review of MEDLINE, EMBASE, SCOPUS, Web of Science, BIOSIS, CINAHL and CENTRAL from inception to November 2020. All study designs reporting pyrocarbon proximal interphalangeal joint arthroplasty in humans were included. Data extracted included information about study characteristics, patient selection, regulatory (gaining research ethics approval) and governance issues (reporting of conflicting interests), operator and centre experience, technique description and outcome reporting. Descriptive and narrative summaries were reported.<h4>Results</h4>From 4316 abstracts, 210 full-text articles were screened. A total of 38 studies and 1434 (1-184) patients were included. These consisted of three case reports, 24 case series, 10 retrospective cohort studies and one randomised trial. Inclusion and exclusion criteria were stated in 25 (66%) studies. Most studies (n = 27, 71%) gained research ethics approval to be conducted. Six studies reported conflicting interests. Experience of operating surgeons was reported in nine (24%) and caseload volume in five studies. There was no consensus about the optimal surgical approach. Technical aspects of implant placement were reported frequently (n = 32) but the detail provided varied widely. Studies reported multiple, heterogenous outcomes. The most commonly reported outcome was range of motion (n = 37).<h4>Conclusions</h4>This systematic review identified inconsistencies in how studies describing the early use and update of an innovative procedure were reported. Incremental evidence was lacking, risking the implant being adopted without robust evaluation. This review adds to evidence highlighting the need for more rigorous evaluation of how implantable medical devices are used in practice following licencing.Paul WelfordNatalie S BlencoweEmily PardingtonConor S JonesJane M BlazebyBarry G MainPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 10, p e0257497 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Paul Welford Natalie S Blencowe Emily Pardington Conor S Jones Jane M Blazeby Barry G Main Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.
description	<h4>Background</h4>In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to understand device use and outcomes since this implant entered clinical practice in order to establish incremental evidence, appropriate study design and reporting. This systematic review summarised and appraised studies reporting pyrocarbon proximal interphalangeal joint arthroplasty.<h4>Methods</h4>Systematic review of MEDLINE, EMBASE, SCOPUS, Web of Science, BIOSIS, CINAHL and CENTRAL from inception to November 2020. All study designs reporting pyrocarbon proximal interphalangeal joint arthroplasty in humans were included. Data extracted included information about study characteristics, patient selection, regulatory (gaining research ethics approval) and governance issues (reporting of conflicting interests), operator and centre experience, technique description and outcome reporting. Descriptive and narrative summaries were reported.<h4>Results</h4>From 4316 abstracts, 210 full-text articles were screened. A total of 38 studies and 1434 (1-184) patients were included. These consisted of three case reports, 24 case series, 10 retrospective cohort studies and one randomised trial. Inclusion and exclusion criteria were stated in 25 (66%) studies. Most studies (n = 27, 71%) gained research ethics approval to be conducted. Six studies reported conflicting interests. Experience of operating surgeons was reported in nine (24%) and caseload volume in five studies. There was no consensus about the optimal surgical approach. Technical aspects of implant placement were reported frequently (n = 32) but the detail provided varied widely. Studies reported multiple, heterogenous outcomes. The most commonly reported outcome was range of motion (n = 37).<h4>Conclusions</h4>This systematic review identified inconsistencies in how studies describing the early use and update of an innovative procedure were reported. Incremental evidence was lacking, risking the implant being adopted without robust evaluation. This review adds to evidence highlighting the need for more rigorous evaluation of how implantable medical devices are used in practice following licencing.
format	article
author	Paul Welford Natalie S Blencowe Emily Pardington Conor S Jones Jane M Blazeby Barry G Main
author_facet	Paul Welford Natalie S Blencowe Emily Pardington Conor S Jones Jane M Blazeby Barry G Main
author_sort	Paul Welford
title	Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.
title_short	Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.
title_full	Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.
title_fullStr	Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.
title_full_unstemmed	Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.
title_sort	systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/670483f50c004e7182cc80a7727455c9
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Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.

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