弯曲与直柄非骨水泥型全髋关节置换术治疗骨关节炎多中心试验（CUSTOM）：一项前瞻性双盲随机对照多中心试验的设计

Curved versus Straight Stem Uncemented Total Hip Arthroplasty Osteoarthritis Multicenter trial (CUSTOM): design of a prospective blinded randomised controlled multicentre trial.

作者信息

van Beers Loes W A H, van Oldenrijk Jakob, Scholtes Vanessa A B, Geerdink Carel H, Niers Bob B A M, Runne Wouter, Bhandari Mohit, Poolman Rudolf W

机构信息

Department of Orthopaedic Surgery, Joint Research, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, The Netherlands.

Department of Orthopaedic Surgery, Academic Medical Center (AMC), Amsterdam, The Netherlands.

出版信息

BMJ Open. 2016 Mar 23;6(3):e010472. doi: 10.1136/bmjopen-2015-010472.

DOI:10.1136/bmjopen-2015-010472

PMID:27009147

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4809092/

Abstract

INTRODUCTION

Answering the demands of an increasingly young and active patient population, recent developments in total hip arthroplasty (THA) have shifted towards minimising tissue damage. The Collum Femoris Preserving (CFP) stem was developed to preserve the trochanteric region of the femur, which potentially preserves the insertion of the gluteus musculature. This might accelerate early postoperative rehabilitation and improve functional outcome. Currently the functional results of the CFP stem have not been compared with conventional straight stems in a randomised controlled trial (RCT). The primary purpose of this trial is to compare the functional result of CFP stem THA with conventional uncemented straight stem THA, measured by the Dutch Hip disability and Osteoarthritis Outcome Score (HOOS) at 3-month follow-up.

METHODS

A prospective blinded multicentre RCT will be performed. We aim to recruit 150 patients. The patients will be randomly allocated to a THA with a straight or a curved stem. All patients, research assistants, clinical assessors and investigators will be blinded for the type of prosthesis for 5 years. Clinical assessments and roentgenograms will be taken preoperative, at 6 weeks after surgery, at 1, 2, 3, 4 and 5 years after surgery. Patient reported outcome measures (PROMs) will be obtained at the same follow-up moments. In addition, the PROMs will also be sent to the patients at 3 and 6 months after surgery. The HOOS at 3-month follow-up will be our primary outcome.

ETHICS AND DISSEMINATION

This trial will be performed in accordance with the Declaration of Helsinki. A local ethics committee has approved this trial. Written informed consent will be obtained from all participating patients. All serious adverse events will be reported to the ethics committee.

RESULTS

Results will be submitted for publication to an orthopaedics related journal.

TRIAL REGISTRATION NUMBER

NTR1560.

摘要

引言

为满足日益年轻化且活动量较大的患者群体的需求，全髋关节置换术（THA）的最新进展已朝着尽量减少组织损伤的方向发展。保留股骨颈（CFP）柄的设计旨在保留股骨的转子区域，这有可能保留臀肌的附着点。这可能会加速术后早期康复并改善功能结果。目前，在随机对照试验（RCT）中，CFP柄的功能结果尚未与传统的直柄进行比较。本试验的主要目的是比较CFP柄THA与传统非骨水泥直柄THA的功能结果，在3个月随访时通过荷兰髋关节残疾和骨关节炎结果评分（HOOS）进行测量。

方法

将进行一项前瞻性双盲多中心RCT。我们的目标是招募150名患者。患者将被随机分配接受直柄或弯柄的THA。所有患者、研究助手、临床评估人员和研究人员将对假体类型进行5年的盲法处理。术前、术后6周、术后1、2、3、4和5年进行临床评估和X线检查。在相同的随访时间点获取患者报告的结局指标（PROMs）。此外，PROMs也将在术后3个月和6个月发送给患者。3个月随访时的HOOS将是我们的主要结局。