直接前入路全髋关节置换术中外侧与传统筋膜切开术预防外侧股皮神经损伤的对比：一项双中心、双盲、随机对照试验的研究方案。

Lateral versus conventional fasciotomy for prevention of lateral femoral cutaneous nerve injury in total hip arthroplasty with direct anterior approach: a study protocol for a dual-center, double-blind, randomized controlled trial.

机构信息

Department of Orthopedic Surgery, Juntendo University, 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan.

Department of Orthopedic Surgery, Juntendo Tokyo Koto Geriatric Medical Center, 3-3-20 Shinsuna, Koutouku, Tokyo, Japan.

出版信息

Trials. 2022 Jul 15;23(1):567. doi: 10.1186/s13063-022-06496-2.

DOI:10.1186/s13063-022-06496-2

PMID:35841003

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9287917/

Abstract

BACKGROUND

An incision for total hip arthroplasty (THA) via the direct anterior approach (DAA) is generally made outside of the space between the sartorius and tensor fasciae latae muscles to prevent lateral femoral cutaneous nerve (LFCN) injury. Anatomical studies have revealed that the LFCN courses between the sartorius and tensor fasciae latae muscles. When the LFCN branches radially while distributing in the transverse direction from the sartorius muscle to the tensor fasciae latae muscle, it is called the fan type. Studies suggest that damage to the fan type LFCN is unavoidable during conventional fasciotomy. We previously demonstrated that injury to non-fan variation LFCN occurred in 28.6% of patients who underwent THA by fasciotomy performed 2 cm away from the intermuscular space. This suggests that the conventional approach also poses a risk of LFCN injury to non-fan variation LFCN. LFCN injury is rarely reported in the anterolateral approach, which involves incision of fascia further away than the DAA. The purpose of this study is to investigate how the position of fasciotomy in DAA affects the risk of LFCN injury.

METHODS

We will conduct a prospective, randomized, controlled study. All patients will be divided into a fan variation and a non-fan variation group using ultrasonography before surgery. Patients with non-fan variation LFCN will receive conventional fasciotomy and lateral fasciotomy in the order specified in the allocation table created in advance by our clinical trial center. The primary endpoint will be the presence of LFCN injury during an outpatient visit using a patient-based questionnaire. The secondary endpoints will be assessed based on patient-reported outcomes at 3 months after surgery in an outpatient setting using the Western Ontario and McMaster Universities Osteoarthritis Index, the Japanese Orthopaedic Association Hip-disease Evaluation Questionnaire, and the Forgotten-Joint Score-12.

DISCUSSION

We hypothesize that the incidence of LFCN injury due to DAA-THA is reduced by making the incision further away from where it is typically made in conventional fasciotomy. If our hypothesis is confirmed, it will reduce the disadvantages of DAA and improve patient satisfaction.

TRIAL REGISTRATION

UMIN Clinical Trials Registry, UMIN000035945 . Registered on 20 February, 2019.

摘要

背景

全髋关节置换术（THA）的直接前入路（DAA）切口通常位于股四头肌和阔筋膜张肌之间的空间之外，以防止外侧股皮神经（LFCN）损伤。解剖学研究表明，LFCN 位于股四头肌和阔筋膜张肌之间。当 LFCN 在从股四头肌向阔筋膜张肌横向分布时呈放射状分支时，称为扇形。研究表明，在常规筋膜切开术中，扇形 LFCN 的损伤是不可避免的。我们之前的研究表明，在筋膜切开术距肌间隙 2cm 处进行 THA 时，28.6%的患者发生非扇形 LFCN 损伤。这表明传统方法也存在 LFCN 对非扇形 LFCN 损伤的风险。在涉及比 DAA 更远的筋膜切开的前外侧入路中，很少有报道 LFCN 损伤。本研究旨在探讨 DAA 中筋膜切开的位置如何影响 LFCN 损伤的风险。

方法

我们将进行一项前瞻性、随机、对照研究。所有患者将在术前使用超声进行股外侧皮神经的扇形和非扇形分组。LFCN 非扇形的患者将根据我们临床试验中心预先创建的分配表，按顺序接受常规筋膜切开术和外侧筋膜切开术。主要终点将是通过基于患者的问卷调查在门诊就诊时是否存在 LFCN 损伤。次要终点将根据术后 3 个月在门诊使用 Western Ontario and McMaster Universities Osteoarthritis Index、日本矫形协会髋关节疾病评估问卷和 Forgotten-Joint Score-12 评估患者报告的结果来评估。