Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
ASST Spedali Civili, UOC Clinica Ortopedica, Piazzale Spedali Civili 1, 25123, Brescia, BS, Italy.
Knee Surg Sports Traumatol Arthrosc. 2023 Nov;31(11):4782-4790. doi: 10.1007/s00167-023-07534-5. Epub 2023 Aug 8.
Although many arthrometers have been developed to assess anterior knee laxity, reliability and diagnostic accuracy of these devices are still debated. The aim of the present study was to evaluate the validity of a new arthrometer in the outpatient setting, with the hypothesis that it had good validity in terms of reliability and diagnostic accuracy.
Seventy-eight subjects (39 with ACL injury and 39 with normal ACL) were tested. ATT was assessed by means of the Lachman test at 30° of flexion with a new testing device (BLU-DAT) under three different loading conditions: 7 kg (69 N), 9 kg (88 N) and maximum (MMT). The tests were performed on both knees to obtain SSD. In the ACL injury group, the tests were performed by two examiners and one of them repeated a second test series. Inter- and intra-observer reliability were assessed with the intraclass correlation coefficients (ICCs) for the average SSD measures. In the normal-ACL group, the analysis was performed with the same testing setup. Side-to-side difference measures of the two groups at every loading condition were compared by Student's t test. Data of test series were dichotomized based on the threshold value of 3-mm SSD as pathological ATT and 2 × 2 contingency tables were used to assess diagnostic accuracy.
The ICCs for intra-observer reliability at 7-kg (69 N), 9-kg (88 N) and MMT measurements were 0.781, 0.855 and 0.913, respectively. The ICC for inter-observer reliability at 7-kg (69 N), 9-kg (88 N) and MMT measurements were 0.701, 0.845 and 0.834, respectively. Comparison between the two groups showed a significant mean difference ranging from 3.4 mm for 7-kg (69 N) load to 4.6 mm for MMT. Overall accuracy ranged from 84.6% for 7-kg load to 98.7% for MMT.
The BLU-DAT has proven to be an instrument with good intra- and inter-observer reliability and very good accuracy in the diagnosis of ACL injuries in the outpatient setting. So, the BLU-DAT can be a new useful tool in everyday clinical practice to assist in the diagnosis of ACL injury.
II.
尽管已经开发出许多关节角度计来评估前膝松弛度，但这些设备的可靠性和诊断准确性仍存在争议。本研究的目的是评估一种新型关节角度计在门诊环境中的有效性，假设其在可靠性和诊断准确性方面具有良好的有效性。
78 名受试者（39 名 ACL 损伤和 39 名 ACL 正常）接受了测试。采用新的测试设备（BLU-DAT）在 30°屈曲下，通过 Lachman 测试评估 ATT，在三种不同的加载条件下进行：7kg（69N）、9kg（88N）和最大（MMT）。对双侧膝关节进行测试以获得 SSD。在 ACL 损伤组中，由两名检查者进行测试，其中一名检查者重复进行第二次测试系列。采用组内相关系数（ICC）评估平均 SSD 测量值的组内和组间可靠性。在 ACL 正常组中，采用相同的测试设置进行分析。使用学生 t 检验比较两种情况下在每个加载条件下的双侧差异。根据 3mm SSD 的阈值将测试系列数据分为病理性 ATT 和 2x2 列联表，并用于评估诊断准确性。
在 7kg（69N）、9kg（88N）和 MMT 测量时，观察者内可靠性的 ICC 分别为 0.781、0.855 和 0.913。观察者间可靠性的 ICC 在 7kg（69N）、9kg（88N）和 MMT 测量时分别为 0.701、0.845 和 0.834。两组之间的比较显示，从 7kg（69N）负荷的 3.4mm 到 MMT 的 4.6mm，平均差异显著。整体准确率从 7kg 负荷的 84.6%到 MMT 的 98.7%。
BLU-DAT 已被证明是一种在门诊环境中具有良好的观察者内和观察者间可靠性和非常高的 ACL 损伤诊断准确性的仪器。因此，BLU-DAT 可以成为日常临床实践中的一种新的有用工具，以协助 ACL 损伤的诊断。
II 级。
