Department of Orthopaedic Surgery, Cleveland Clinic Florida, Weston, Florida (NAS).
Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (CDM).
Foot Ankle Spec. 2021 Aug;14(4):366-371. doi: 10.1177/1938640020937160. Epub 2020 Jul 3.
Hallux rigidus is a common pathology afflicting the foot, for which various joint salvage techniques have been described with a multitude of different implants. Recently, a synthetic cartilage implant composed of polyvinyl alcohol (PVA) received FDA premarket approval for the treatment of arthritis of the great toe. The purpose of this study was to (1) systematically review the clinical evidence supporting the use of a PVA implant in hallux rigidus and (2) determine the strength of the recommendation that can be made supporting the use of a PVA implant by evaluating the quality of evidence available. A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. Using the terms "cartiva OR polyvinyl alcohol OR synthetic cartilage OR hemiarthroplasty AND hallux rigidus OR great toe arthritis OR first toe arthritis" we searched the PubMed/Medline database. The quality of the included studies was evaluated using the American Academy of Orthopaedic Surgeons Clinical Practice Guideline and Systematic Review Methodology. Seven studies met the inclusion criteria, 6 of these were derived from a single randomized controlled trial. A moderate recommendation can be given for the use of a PVA implant for hallux rigidus based on short-term outcomes. A limited recommendation can be given for the use of a PVA implant for hallux rigidus based on mid-term outcomes. There are limited studies available detailing the outcomes of a PVA implant for hallux rigidus; however, the results that are available demonstrate a high level of evidence. Level I: Systematic review.
拇僵硬是一种常见的足部疾病,已经有多种关节保存技术和多种不同的植入物被描述。最近,一种由聚乙烯醇(PVA)组成的合成软骨植入物获得了 FDA 的上市前批准,用于治疗大脚趾关节炎。本研究的目的是:(1)系统回顾支持使用 PVA 植入物治疗拇僵硬的临床证据;(2)通过评估现有证据的质量,确定支持使用 PVA 植入物的推荐强度。根据系统评价和荟萃分析的首选报告项目进行了系统评价。使用术语“cartiva 或聚乙烯醇或合成软骨或半关节成形术和拇僵硬或大脚趾关节炎或第一脚趾关节炎”,我们搜索了 PubMed/Medline 数据库。使用美国矫形外科医师学会临床实践指南和系统评价方法学评估纳入研究的质量。有 7 项研究符合纳入标准,其中 6 项来自单一随机对照试验。根据短期结果,可以对 PVA 植入物治疗拇僵硬给予适度推荐。根据中期结果,可以对 PVA 植入物治疗拇僵硬给予有限推荐。目前,只有有限的研究详细描述了 PVA 植入物治疗拇僵硬的结果;然而,现有的结果表明证据水平很高。等级 I:系统评价。