North Bristol NHS Trust, Bristol, United Kingdom.
Bristol Centre for Surgical Research, Department of Population Health Sciences, Bristol Medical School, Bristol, United Kingdom.
PLoS One. 2021 Oct 19;16(10):e0257497. doi: 10.1371/journal.pone.0257497. eCollection 2021.
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.
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.
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).
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.
2002 年，一种热解碳指间关节植入物获得了美国食品和药物管理局的批准，但仅有有限的有效性证据。了解该植入物进入临床实践后的使用情况和结果非常重要，以便建立增量证据、适当的研究设计和报告。本系统评价总结和评估了报告热解碳近指间关节关节成形术的研究。
系统检索 MEDLINE、EMBASE、SCOPUS、Web of Science、BIOSIS、CINAHL 和 CENTRAL 从建库至 2020 年 11 月的所有研究。纳入所有报告人类热解碳近指间关节关节成形术的研究设计。提取的数据包括研究特征、患者选择、监管（获得研究伦理批准）和治理问题（报告利益冲突）、手术医生和中心经验、技术描述和结果报告等信息。报告了描述性和叙述性总结。
从 4316 篇摘要中筛选出 210 篇全文文章。共纳入 38 项研究和 1434（1-184）例患者。这些研究包括 3 例病例报告、24 例病例系列、10 项回顾性队列研究和 1 项随机试验。25 项（66%）研究陈述了纳入和排除标准。大多数研究（n=27，71%）获得了开展研究的伦理批准。6 项研究报告了利益冲突。9 项（24%）研究报告了手术医生的经验，5 项研究报告了病例量。对于最佳手术入路，尚无共识。植入物放置的技术方面经常被报道（n=32），但提供的细节差异很大。研究报告了多种、异质的结果。报告最多的结果是活动范围（n=37）。
本系统评价发现，描述创新性手术早期使用和更新的研究报告方式存在不一致。缺乏增量证据，有可能在没有严格评估的情况下采用该植入物。本综述增加了证据，强调了在获得许可后，需要更严格地评估可植入医疗器械在实践中的使用情况。
