骨折愈合后取除植入物的临床结果。一项前瞻性多中心临床队列研究的设计。
Clinical outcome of implant removal after fracture healing. Design of a prospective multicentre clinical cohort study.
机构信息
Department of Surgery, Amphia Hospital Breda, Breda, the Netherlands.
出版信息
BMC Musculoskelet Disord. 2012 Aug 15;13:147. doi: 10.1186/1471-2474-13-147.
BACKGROUND
The clinical results of removal of metal implants after fracture healing are unknown and the question whether to remove or to leave them in is part of discussion worldwide. We present the design of a prospective clinical multicentre cohort study to determine the main indications for and expectations of implant removal, the influence on complaints, the incidence of surgery related complications and the socio-economic consequences of implant removal.
METHODS/DESIGN: In a prospective multicentre clinical cohort study at least 200 patients with a healed fracture after osteosynthesis with a metal implant are included for analyzing the outcome after removal. Six hospitals in the Netherlands are participating. Special questionnaires are designed. The follow up after surgery will be at least six months. The primary endpoint is the incidence of surgery related complications. Secondary endpoints are the influence of removal on preoperative symptoms and complaints and the socio-economic consequences.
DISCUSSION
By performing this study we hope to find profound arguments to remove or not to remove metal implants after fracture healing that can help to develop clear guidelines for daily practice.
TRIAL REGISTRATION
NTR1297, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1297.
背景
骨折愈合后取出金属植入物的临床结果尚不清楚，是否取出或保留这些植入物是全球讨论的一部分。我们提出了一项前瞻性临床多中心队列研究的设计，以确定取出植入物的主要指征和预期、对投诉的影响、手术相关并发症的发生率以及取出植入物的社会经济后果。
方法/设计：在一项前瞻性多中心临床队列研究中，至少纳入 200 例骨折愈合后采用金属植入物内固定的患者，以分析取出后的结果。荷兰的 6 家医院参与其中。专门设计了特殊的调查问卷。术后随访至少 6 个月。主要终点是手术相关并发症的发生率。次要终点是去除对术前症状和投诉的影响以及社会经济后果。
讨论
通过进行这项研究，我们希望找到有力的论据来决定在骨折愈合后是否取出金属植入物，这有助于为日常实践制定明确的指南。
试验注册
NTR1297，http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1297。
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