mediCAD®软件在全髋关节置换术全数字化术前规划中的应用验证：一项回顾性研究。

IF 2.3 3区医学 Q2 ORTHOPEDICS

Orthopaedics & Traumatology-Surgery & Research Pub Date : 2024-07-22 DOI:10.1016/j.otsr.2024.103941

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引用次数: 0

摘要

导言：全髋关节置换术（THA）前的规划步骤至关重要。数字规划软件程序的使用越来越广泛，但有关此类工具可靠性的研究报告却寥寥无几。此外，尽管mediCAD®软件在法国被广泛使用，但尚未有针对该软件的研究。因此，我们开展了一项回顾性研究，旨在(1）评估该规划软件的准确性；（2）确定评分者内部和评分者之间的可靠性；（3）确定肥胖如何影响规划的准确性：假设：使用mediCAD®软件进行THA规划准确可靠：这是一项单中心回顾性研究。患者：这是一项单一中心的回顾性研究，由一位经验丰富的外科医生连续完成了 1001 例手术，并由两位盲人外科医生在两个不同的场合进行了回顾性规划。90例（89%）髋臼杯采用骨水泥固定，11例（11%）采用无骨水泥固定。21个髋关节（21%）使用了双活动度髋臼杯。60个髋关节（59%）使用了股骨柄骨水泥。终点是精确计划的数量，精确计划的定义是与实际植入物的尺寸相同。可接受的匹配定义为相差一个尺寸。如果髋臼杯的计划尺寸与植入尺寸相差超过2个尺寸，或股骨柄的计划尺寸与植入尺寸相差超过1个尺寸，则为不可接受的匹配。使用带 95% 置信区间 (CI) 的类内相关系数 (ICC) 计算评分者内部和评分者之间的可靠性：结果：相对于所用植入物，第一评分员发现 15 个计划中的髋臼杯（15%）和 45 个计划中的股骨柄（45%）完全一致。第二位评分者对 20 个计划中的髋臼杯（20%）和 50 个计划中的股骨柄（50%）的评分完全一致。第一和第二评分者对髋臼杯的评分内可靠性分别为平均（ICC = 0.57; 95%CI [0.43-0.69]）和较差（ICC = 0.38 95%CI [0.20-054]）。股骨柄的第一评分人（ICC = 0.47 95%CI [0.30-0.61]）和第二评分人（ICC = 0.45 95%CI [0.29-0.60]）的评分人内可靠性较差。计划中的髋臼杯（ICC = 0.39 95%CI [0.21-0.54]）和计划中的股骨柄（ICC = 0.42 95%CI [0.24-0.57]）的观察者间可靠性较低。总体而言，将两个评分器结合起来，非肥胖患者中有31个髋关节（19%）和肥胖患者中有7个髋关节（21%）实现了对髋臼杯的准确预测（P = 0.62）：讨论：本研究发现mediCAD®软件的可靠性是可以接受的。讨论：本研究发现，mediCAD® 软件的可靠性是可以接受的。在本研究中，经验水平、X光片放大率会影响规划结果，但肥胖不会。我们目前还没有能力将可靠的放射比例尺纳入二维模板。有些外科医生喜欢使用 CT 扫描，但这比传统的射线照片成本更高，而且患者会受到更多辐射。本研究表明，mediCAD® 软件能为 THA 的术前规划提供令人满意的输出结果：证据等级：III；回顾性、诊断性、对比研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Validation of mediCAD® software for fully digital preoperative planning of total hip arthroplasty: a retrospective study

Introduction

The planning step that precedes a total hip arthroplasty (THA) procedure is crucial. Digital planning software programs are being increasingly used, although few studies have reported on the reliability of such tools. Furthermore, no studies have been conducted on the mediCAD® software, despite it being widely used in France. This led us to conduct a retrospective study to: (1) assess the accuracy of this planning software, (2) determine the intra- and inter-rater reliability, (3) determine how obesity affects the accuracy of planning.

Hypothesis

THA planning is accurate and reliable when using the mediCAD® software.

Patients and methods

This was a single center, retrospective study. One hundred one consecutive cases performed by a single experienced surgeon were planned retrospectively by two blinded surgeons on two separate occasions. The acetabular cup was cemented in 90 hips (89%), cementless in 11 hips (11%). A dual mobility cup was used in 21 hips (21%). The femoral stem was cemented in 60 hips (59%). The endpoint was the number of exact plans, defined as the same size as the actual implants. An acceptable match was defined as a difference of one size. The match was unacceptable if the planned and implanted size differed by more than 2 for the acetabular cup or by more than 1 size for the femoral stem. The intra-rater and inter-rater reliability were calculated using the intraclass correlation coefficient (ICC) with 95% confidence intervals (CI).

Results

Exact agreement was found by the first rater for 15 planned acetabular cups (15%) and for 45 planned femoral stems (45%) relative to the implants used. The second rater reached exact agreement for 20 planned acetabular cups (20%) and 50 planned femoral stems (50%). The intra-rater reliability for the acetabular cup was average (ICC = 0.57; 95%CI [0.43–0.69]) and poor (ICC = 0.38 95%CI [0.20–054]) for the 1st and 2nd rater, respectively. The intra-rater reliability for the femoral stem was poor for the 1st rater (ICC = 0.47 95%CI [0.30–0.61]) and the 2nd rater (ICC = 0.45 95%CI [0.29–0.60]). The interobserver reliability was low for the planned acetabular cup (ICC = 0.39 95%CI [0.21–0.54]) and the planned femoral stem (ICC = 0.42 95%CI [0.24–0.57]). Overall, when combining the two raters, exact prediction of the acetabular cup was achieved in 31 hips (19%) in non-obese patients and in 7 hips (21%) in obese patients (p = 0.62).

Discussion

This study found acceptable reliability of the mediCAD® software. Experience level, radiograph magnification affected the planning outcome in this study, but obesity did not. We currently do not have the ability to incorporate a reliable radiological scale for two-dimensional templating. Some surgeons prefer using a CT scan, but this costs more than conventional radiographs and exposes the patient to more radiation. This study shows that the mediCAD® software can provide satisfactory output for the preoperative planning of THA.

Level of evidence

III; retrospective, diagnostic, comparative study

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来源期刊

Orthopaedics & Traumatology-Surgery & Research 医学-外科

CiteScore

5.10

自引率

26.10%

发文量

329

审稿时长

12.5 weeks

期刊介绍： Orthopaedics & Traumatology: Surgery & Research (OTSR) publishes original scientific work in English related to all domains of orthopaedics. Original articles, Reviews, Technical notes and Concise follow-up of a former OTSR study are published in English in electronic form only and indexed in the main international databases.