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初次全膝关节置换术后使用弹性加压绷带是否有益?

Does an Elastic Compression Bandage Provide Any Benefit After Primary TKA?

机构信息

The Rothman Institute of Orthopedics at Thomas Jefferson University, Philadelphia, PA, USA.

出版信息

Clin Orthop Relat Res. 2019 Jan;477(1):134-144. doi: 10.1097/CORR.0000000000000459.

Abstract

BACKGROUND

Compression bandages often are used after TKA to reduce swelling. However, the degree to which they are helpful has not been well characterized.

QUESTIONS/PURPOSES: The purpose of this study was to determine whether use of a compression bandage after TKA was associated with (1) less leg swelling (our primary endpoint); or (2) secondary study endpoints, including improved ROM of flexion and extension, lower visual analog scale (VAS) pain scores for worst pain and pain during physical therapy just before surgery, postoperative day (POD) 1, POD 2, and POD 28, or fewer wound complications within 90 days of surgery.

METHODS

A prospective, single-center, two-arm, parallel-group randomized controlled trial was conducted on 51 patients undergoing simultaneous, bilateral, primary TKA between February 2015 and August 2016. Patients were excluded if they had a body mass index > 40 kg/m, a history of a venous thromboembolic event, an allergy to the dressing or compression bandage, or lymphedema in one or both legs. Participants averaged a mean age of 62 years (range, 40-83 years). In all patients, we released the tourniquet after full wound closure, and we applied an Aquacel dressing to both limbs. Patients were randomized by opaque envelope, and the compression bandage was applied to the randomized limb. For each leg, study personnel not involved in patient care measured the patients' limb circumference (thigh, knee, and tibia), ROM, and VAS pain scores 24 hours after surgery, 48 hours after surgery, and on POD 28. The minimal clinically important difference for circumference was 2 cm with a SD of 2 cm in the circumference. For VAS, it was 2 points with a SD of 2. For ROM, it was 10° with a SD of 15. We conservatively picked an effect size of 0.5 SD and assumed a correlation between limbs of 0.3. This set the power level at 0.80 with an α error of 0.05; thus, a power analysis for paired t-tests indicated that 45 patients would be an appropriate sample size. There were 29 patients randomized to the right leg group and 22 patients randomized to the left leg group. There were no differences between the limb with and without the compression bandage preoperatively.

RESULTS

Postoperatively, there were no differences between the groups in terms of leg swelling at the thigh (POD 1: mean ± SD = 51 ± 6 with compression bandage versus mean ± SD = 51 ± 6 without compression bandage, mean Δ = - 0.14, 95% confidence interval [CI], -0.65 to 0.37], p = 0.586; POD 2: mean ± SD = 53 ± 6 with compression bandage versus mean ± SD = 53 ± 7 without compression bandage, mean Δ = -0.22, 95% CI, -0.95 to 0.51, p = 0.548; POD 28: mean ± SD = 47 ± 6 with compression bandage versus mean ± SD = 47 ± 6 without compression bandage, mean Δ = -0.01, 95% CI, -0.39 to 0.38, p = 0.975), knee (POD 1: mean ± SD = 45 ± 4 with compression bandage versus mean ± SD = 45 ± 5 without compression bandage, mean Δ = -0.44, 95% CI, -1.16 to 0.28, p = 0.223; POD 2: mean ± SD = 46 ± 4 with compression bandage versus mean ± SD = 46 ± 4 without compression bandage, mean Δ = -0.30, 95% CI, -0.69 to 0.10, p = 0.137; POD 28: mean ± SD = 42 ± 5 with compression bandage versus mean ± SD = 42 ± 5 without compression bandage, mean Δ = 0.21, 95% CI, -0.34 to 0.76, p = 0.446), and shin (POD 1: mean ± SD = 40 ± 4 with compression bandage versus mean ± SD = 40 ± 4 without compression bandage, mean Δ = -0.22, 95% CI, -1.23 to 0.79, p = 0.659; POD 2: mean ± SD = 41 ± 4 with compression bandage versus mean ± SD = 41 ± 4 without compression bandage, mean Δ = -0.31, 95% CI, -0.72 to 0.09, p = 0.126; POD 28: mean ± SD = 37 ± 4 with compression bandage versus mean ± SD = 37 ± 4 without compression bandage, mean Δ = -0.34, 95% CI, -0.92 to 0.24, p = 0.246). There were no differences between the groups in terms of flexion ROM (POD 1: mean ± SD = 56 ± 25 with compression bandage versus mean ± SD = 58 ± 22 without compression bandage, mean Δ = -2.63, p = 0.234; POD 2: mean ± SD = 64 ± 20 with compression bandage versus mean ± SD = 63 ± 23 without compression bandage, mean Δ = 1.22, p = 0.534; POD 28: mean ± SD = 101 ± 20 with compression bandage versus mean ± SD = 102 ± 20 without compression bandage, mean Δ = -1.64, p = 0.103) and extension (POD 1: mean ± SD = 12 ± 7 with compression bandage versus mean ± SD = 12 ± 7 without compression bandage, mean Δ = 0.51, p = 0.328; POD 2: mean ± SD = 9 ± 5 with compression bandage versus mean ± SD = 10 ± 6 without compression bandage, mean Δ = -1.28, p = 0.061; POD 28: mean ± SD = 6 ± 14 with compression bandage versus mean ± SD = 4 ± 4 without compression bandage, mean Δ = 2.19, p = 0.252). With the numbers available, we observed greater maximal postoperative pain for the limb with the compression bandage than the control limb on POD 1 and POD 2, but not on POD 28 (POD 1: mean ± SD = 8 ± 3 with compression bandage versus mean ± SD = 7 ± 3 without compression bandage, mean Δ = 0.66, p = 0.030; POD 2: mean ± SD = 7 ± 2 with compression bandage versus mean ± SD = 7 ± 3 without compression bandage, mean Δ = 0.80, p = 0.008; POD 28: mean ± SD = 4 ± 3 with compression bandage versus mean ± SD = 3 ± 3 without compression bandage, mean Δ = 0.14, p = 0.526). Likewise, there was greater pain during physical therapy for the limb with the compression bandage than the limb without on POD 2, but not on POD 1 and POD 28 (POD 1: mean ± SD = 7 ± 3 with compression bandage versus mean ± SD = 6 ± 3 without compression bandage, mean Δ = 0.29, p = 0.460; POD 2: mean ± SD = 8 ± 2 with compression bandage versus mean ± SD = 7 ± 3 without compression bandage, mean Δ = 0.67, p = 0.018; POD 28: mean ± SD = 5 ± 2 with compression bandage versus mean ± SD = 5 ± 3 without compression bandage, mean Δ = 0.14, p = 0.600). With the numbers available, we observed no difference in 90-day wound healing complications between the limb with and the limb without the compression dressing; however, the sample size was too small to analyze this in a meaningful statistical way. Overall, there were 6% total wound complications in the compression bandage group and 12% total wound complications in the group without the compression bandage (odds ratio [OR], 0.47; p = 0.487). Drainage was not observed in the group with the compression bandage, whereas the group without the compression bandage had 6% drainage (OR, 0.00; p = 0.243). There were no deep infections or reoperations within 90 days postoperatively.

CONCLUSIONS

Applying a compression bandage after TKA did not result in any clinical improvement in limb circumference, ROM, or pain. Based on this study, we believe that applying a compression bandage after TKA neither benefits nor harms the patient. Thus, we no longer use compression dressings for routine primary TKA.

LEVEL OF EVIDENCE

Level I, therapeutic study.

摘要

背景

膝关节置换术后常使用加压绷带以减轻肿胀。然而,其有益程度尚未得到很好的描述。

问题/目的:本研究旨在确定膝关节置换术后使用加压绷带是否与以下情况相关:(1)腿部肿胀减轻(主要终点);或(2)次要研究终点,包括膝关节屈伸活动范围(ROM)改善、术后疼痛视觉模拟量表(VAS)评分(最差疼痛和物理治疗前的疼痛)降低、术后第 1 天(POD1)、第 2 天(POD2)和第 28 天(POD28)、或术后 90 天内伤口并发症减少。

方法

2015 年 2 月至 2016 年 8 月,对 51 例双侧、同期、初次膝关节置换患者进行了前瞻性、单中心、两臂、平行组随机对照试验。排除标准包括体重指数(BMI)>40kg/m2、静脉血栓栓塞事件史、对敷料或加压绷带过敏、或单肢或双肢淋巴水肿。参与者平均年龄 62 岁(范围,40-83 岁)。在所有患者中,我们在完全闭合伤口后松开止血带,并在双肢上应用 Aquacel 敷料。患者通过不透明信封随机分组,加压绷带应用于随机肢体。对于每条肢体,由不参与患者护理的工作人员测量患者的肢体周径(大腿、膝盖和胫骨)、ROM 和 VAS 疼痛评分,术后 24 小时、48 小时和 POD28。周径的最小临床重要差异为 2cm,周径的标准差为 2cm。对于 VAS,为 2 分。对于 ROM,为 10°,标准差为 15°。我们保守地选择了 0.5 SD 的效应量,并假设四肢之间的相关性为 0.3。这设定了 0.80 的功效水平和 0.05 的α错误;因此,配对 t 检验的功效分析表明,45 例患者是适当的样本量。29 例患者随机分为右腿组,22 例患者随机分为左腿组。术前肢体之间在加压带与无加压带之间无差异。

结果

术后,在大腿肿胀方面,两组之间没有差异(POD1:加压带与无加压带的平均±SD 分别为 51±6 和 51±6,平均Δ= -0.14,95%置信区间[CI],-0.65 至 0.37,p=0.586;POD2:加压带与无加压带的平均±SD 分别为 53±6 和 53±7,平均Δ= -0.22,95%CI,-0.95 至 0.51,p=0.548;POD28:加压带与无加压带的平均±SD 分别为 47±6 和 47±6,平均Δ= -0.01,95%CI,-0.39 至 0.38,p=0.975)、膝盖(POD1:加压带与无加压带的平均±SD 分别为 45±4 和 45±5,平均Δ= -0.44,95%CI,-1.16 至 0.28,p=0.223;POD2:加压带与无加压带的平均±SD 分别为 46±4 和 46±4,平均Δ= -0.30,95%CI,-0.69 至 0.10,p=0.137;POD28:加压带与无加压带的平均±SD 分别为 42±5 和 42±5,平均Δ= 0.21,95%CI,-0.34 至 0.76,p=0.446)和胫骨(POD1:加压带与无加压带的平均±SD 分别为 40±4 和 40±4,平均Δ= -0.22,95%CI,-1.23 至 0.79,p=0.659;POD2:加压带与无加压带的平均±SD 分别为 41±4 和 41±4,平均Δ= -0.31,95%CI,-0.72 至 0.09,p=0.126;POD28:加压带与无加压带的平均±SD 分别为 37±4 和 37±4,平均Δ= -0.34,95%CI,-0.92 至 0.24,p=0.246)。在膝关节屈伸 ROM 方面,两组之间没有差异(POD1:加压带与无加压带的平均±SD 分别为 56±25 和 58±22,平均Δ= -2.63,p=0.234;POD2:加压带与无加压带的平均±SD 分别为 64±20 和 63±23,平均Δ= 1.22,p=0.534;POD28:加压带与无加压带的平均±SD 分别为 101±20 和 102±20,平均Δ= -1.64,p=0.103)和伸展(POD1:加压带与无加压带的平均±SD 分别为 12±7 和 12±7,平均Δ= 0.51,p=0.328;POD2:加压带与无加压带的平均±SD 分别为 9±5 和 10±6,平均Δ= -1.28,p=0.061;POD28:加压带与无加压带的平均±SD 分别为 6±14 和 4±4,平均Δ= 2.19,p=0.252)。根据现有的数字,我们观察到在术后第 1 天和第 2 天,加压绷带肢体的最大术后疼痛比对照肢体更大,但在术后第 28 天没有观察到(POD1:加压带与无加压带的平均±SD 分别为 8±3 和 7±3,平均Δ= 0.66,p=0.030;POD2:加压带与无加压带的平均±SD 分别为 7±2 和 7±2,平均Δ= 0.80,p=0.008;POD28:加压带与无加压带的平均±SD 分别为 4±3 和 3±3,平均Δ= 0.14,p=0.526)。同样,在术后第 2 天,加压绷带肢体的物理治疗疼痛比无加压带肢体更大,但在术后第 1 天和第 28 天没有观察到(POD1:加压带与无加压带的平均±SD 分别为 7±3 和 6±3,平均Δ= 0.29,p=0.460;POD2:加压带与无加压带的平均±SD 分别为 8±2 和 7±3,平均Δ= 0.67,p=0.018;POD28:加压带与无加压带的平均±SD 分别为 5±2 和 5±3,平均Δ= 0.14,p=0.600)。根据现有的数字,我们观察到加压绷带肢体和无加压绷带肢体在 90 天内伤口愈合并发症没有差异;然而,由于样本量太小,无法以有意义的统计方式进行分析。总的来说,加压绷带组的总伤口并发症发生率为 6%,无加压绷带组的总伤口并发症发生率为 12%(比值比[OR],0.47;p

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