Burns Katherine A, Robbins Lynn M, LeMarr Angela R, Childress Amber L, Morton Diane J, Wilson Melissa L
SSM Health Orthopedics, SSM Health DePaul Hospital, St. Louis, MO, USA.
University of Southern California, Keck School of Medicine, Department of Preventive Medicine, Los Angeles, CA, USA.
JSES Int. 2020 Dec 8;5(2):247-253. doi: 10.1016/j.jseint.2020.10.011. eCollection 2021 Mar.
Use of anti-inflammatory medications (NSAIDs) is an important component of multimodal pain control after orthopedic procedures to avoid opioid overutilization and abuse. However, the deleterious effects of NSAIDs on tendon healing are of particular concern in rotator cuff repair (RCR). The purpose of this study was to evaluate the effect of celecoxib or placebo on healing rates after RCR when administered in the perioperative and immediate postoperative period using MRI evaluation at one year postoperatively. A secondary aim was to determine whether clinical differences existed between patients with intact or non-intact repairs.
Patients aged ≤65 years with partial- or full-thickness rotator cuff tear (<25x25 mm) were randomized to receive celecoxib 400 mg or placebo 1 hour before the procedure and 200mg bid for 3 weeks postoperatively. All patients were treated as clinically indicated at the time of surgery and followed standard postoperative protocol. Repair integrity was evaluated with MRI using the Sugaya classification for repair integrity. Data were analyzed using multivariable logistic regression by intent to treat.
Seventy-nine patients were enrolled; 21 were lost to follow-up, 6 did not have cuff repair, 5 were revised, and 2 declined follow-up, leaving 45 patients with one-year follow-up. Five of these patients did not complete MRI, leaving 40 patients for review. Eighteen of 20 patients (90%) who received celecoxib completed all doses of study medication as did 15 of 20 patients (75%) who received placebo. The patient groups were similar for demographics, clinical results, and healing rate. After adjusting for tear size, no statistically significant difference in healing rate was found between groups, with 10 of 20 celecoxib patients (50%) having intact repair at 1 year compared with 14 of 20 placebo patients (70%) (OR = 0.53, 95% CI: 0.14, 2.08, = 0.35).
Half of the patients who received celecoxib had an intact repair compared with 70% intact repair for patients receiving placebo. Although not statistically significant in this small study, larger studies are needed to clarify this important clinical concern. The authors do not recommend use of celecoxib for postoperative pain control after RCR.
使用抗炎药物(非甾体抗炎药)是骨科手术后多模式疼痛控制的重要组成部分,以避免阿片类药物的过度使用和滥用。然而,非甾体抗炎药对肌腱愈合的有害影响在肩袖修复(RCR)中尤为令人担忧。本研究的目的是在术后一年使用MRI评估,评估塞来昔布或安慰剂在围手术期和术后即刻给药时对RCR后愈合率的影响。次要目的是确定修复完整或不完整的患者之间是否存在临床差异。
年龄≤65岁、肩袖部分或全层撕裂(<25x25mm)的患者被随机分为在手术前1小时接受400mg塞来昔布或安慰剂,并在术后3周每天两次接受200mg治疗。所有患者在手术时均按临床指征进行治疗,并遵循标准的术后方案。使用Sugaya修复完整性分类通过MRI评估修复完整性。按意向性治疗使用多变量逻辑回归分析数据。
79名患者入组;21名失访,6名未进行袖带修复,5名进行了翻修,2名拒绝随访,最终45名患者进行了一年随访。其中5名患者未完成MRI,最终40名患者可供评估。接受塞来昔布的20名患者中有18名(90%)完成了所有剂量的研究药物治疗,接受安慰剂的20名患者中有15名(75%)完成了治疗。两组患者在人口统计学、临床结果和愈合率方面相似。在调整撕裂大小后,两组之间的愈合率没有统计学上的显著差异,接受塞来昔布的20名患者中有10名(50%)在1年时修复完整,而接受安慰剂的20名患者中有14名(70%)(比值比=0.53,95%置信区间:0.14,2.08,P=0.35)。
接受塞来昔布的患者中有一半修复完整,而接受安慰剂的患者中有70%修复完整。尽管在这项小型研究中没有统计学意义,但需要更大规模的研究来阐明这一重要的临床问题。作者不建议在RCR术后使用塞来昔布进行疼痛控制。