Giordano Brian D
Department of Sports Medicine and Hip Preservation, University of Rochester Medical Center, Rochester, New York USA
J Ultrasound Med. 2016 Jun;35(6):1259-67. doi: 10.7863/ultra.15.07004. Epub 2016 May 5.
Intra-articular hip joint injections have traditionally relied on the use of image guidance to confirm intra-articular needle placement. Musculoskeletal ultrasound (US) has emerged as a popular tool to aid the clinician in performing intra-articular hip injections. Modern automated injection delivery systems are commercially available and may offer the potential to optimize clinical efficiency while limiting procedural morbidity. The purpose of this study was to compare patient-reported outcomes and clinical efficiency between two US-guided intra-articular hip injection techniques. The hypothesis was that the use of an automated delivery system for US-guided intra-articular hip joint injections would show superiority in clinical efficiency over traditional syringe injections.
This study was a level 1 randomized prospective postmarket clinical evaluation. Forty patients were randomly assigned to undergo a single intra-articular corticosteroid injection of the hip using either an automated delivery system (Navigator Delivery System; Carticept Medical, Inc, Alpharetta, GA) or a traditional syringe injection. Enrolled patients were prospectively followed at 1, 6, and 12 weeks after injection. A battery of patient-reported outcomes were collected at baseline and again at 1, 6, and 12 weeks after injection. Preparation times were documented for all injections.
Forty patients met inclusion criteria and were enrolled. Twenty patients were randomly assigned to receive US guided intra-articular hip injections using the automated system (group A), and 20 patients were treated with standard syringe injections (group B). Body mass index, smoking history, symptom duration, baseline patient-reported outcomes, and demographic data were similar between groups. Improvements from baseline scores were noted at all time points for all patient-reported outcomes regardless of the injection technique used. However, no significant differences were noted at any time point for any of the patient-reported outcomes based on which injection delivery system was used. Statistically significant differences were noted at 6 and 12 weeks for the subjective global assessment score, which favored the use of the automated delivery system over the standard injection technique (6 weeks, P = .029; 12 weeks, P = .028). Between the two injection procedures, there was no difference in pain experienced by the patient (mean Visual Analog Scale pain score ± SEM: group A, 34.9 ± 6.49; group B, 34.5 ± 5.99; P = .960). Body mass index did not influence pain associated with an intra-articular hip injection (P = .870); however, younger patient age was found to be an independent predictor of increased pain associated with injection (P = .011). Although there were no differences among male or female patients in hip injection pain based on the delivery method, statistically significant differences were encountered between male and female patients, irrespective of treatment assignment (male/female: group A, 25.1/41.4; group B, 26.7/46.1; P= .049). Among patients with a smoking history, large differences were noted for injection pain when data for both groups were pooled, regardless of the delivery method (no history, 30.0 ± 4.86; smoking history, 40.8 ± 9.94). Clinical efficiency (as measured by injection preparation time) was found to be inferior for the automated system compared to traditional syringe injection (P < .0001).
Use of an automated delivery system for US-guided intra-articular hip injections did not show superior efficiency or patient comfort over traditional syringe injections. Intra-articular corticosteroid injections led to clinically and statistically significant improvements in pain and function for patients with intra-articular hip pain, irrespective of the delivery method. Smoking history and female sex were independent predictors of increased pain associated with intra-articular hip joint injections.
髋关节腔内注射传统上依赖影像引导来确认针是否置于关节腔内。肌肉骨骼超声(US)已成为帮助临床医生进行髋关节腔内注射的常用工具。现代自动注射给药系统已上市,可能有助于优化临床效率并减少操作相关的发病率。本研究的目的是比较两种超声引导下髋关节腔内注射技术在患者报告的结局和临床效率方面的差异。假设是超声引导下髋关节腔内注射使用自动给药系统在临床效率上优于传统注射器注射。
本研究为1级随机前瞻性上市后临床评估。40例患者被随机分配,使用自动给药系统(Navigator给药系统;Carticept Medical公司,佐治亚州阿尔法利塔)或传统注射器进行单次髋关节腔内皮质类固醇注射。对纳入的患者在注射后1、6和12周进行前瞻性随访。在基线以及注射后1、6和12周再次收集一系列患者报告的结局。记录所有注射的准备时间。
40例患者符合纳入标准并被纳入研究。20例患者被随机分配使用自动系统接受超声引导下髋关节腔内注射(A组),20例患者接受标准注射器注射(B组)。两组患者在体重指数、吸烟史、症状持续时间、基线患者报告的结局和人口统计学数据方面相似。无论采用何种注射技术,所有患者报告的结局在所有时间点均较基线评分有所改善。然而,基于所使用的注射给药系统,在任何时间点的任何患者报告的结局方面均未发现显著差异。在主观整体评估评分方面,在6周和第12周发现了统计学上的显著差异,自动给药系统优于标准注射技术(6周,P = 0.029;12周,P = 0.028)。在两种注射方法之间,患者经历的疼痛没有差异(平均视觉模拟量表疼痛评分±标准误:A组,34.9±6.49;B组,34.5±5.99;P = 0.960)。体重指数不影响髋关节腔内注射相关的疼痛(P = 0.870);然而,发现患者年龄较小是注射相关疼痛增加的独立预测因素(P = 0.011)。尽管基于给药方式,男性和女性患者在髋关节注射疼痛方面没有差异,但无论治疗分配如何,男性和女性患者之间存在统计学上的显著差异(男性/女性:A组,25.1/41.4;B组,26.7/46.1;P = 0.049)。在有吸烟史的患者中,将两组数据合并后,无论给药方式如何,注射疼痛均存在较大差异(无吸烟史,30.0±4.86;有吸烟史,40.8±9.94)。发现自动系统的临床效率(以注射准备时间衡量)低于传统注射器注射(P < 0.0001)。
超声引导下髋关节腔内注射使用自动给药系统在效率或患者舒适度方面并不优于传统注射器注射。髋关节腔内皮质类固醇注射使髋关节腔内疼痛患者的疼痛和功能在临床和统计学上有显著改善,与给药方式无关。吸烟史和女性性别是髋关节腔内注射相关疼痛增加的独立预测因素。