Posterior cervical foraminotomy versus anterior cervical discectomy for Cervical Brachialgia: the FORVAD RCT.

IF 3.5 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Simon Thomson, Gemma Ainsworth, Senthil Selvanathan, Rachel Kelly, Howard Collier, Ruben Mujica-Mota, Rebecca Talbot, Sarah Tess Brown, Julie Croft, Nikki Rousseau, Ruchi Higham, Yahia Al-Tamimi, Neil Buxton, Nicholas Carleton-Bland, Martin Gledhill, Victoria Halstead, Peter Hutchinson, James Meacock, Nitin Mukerji, Debasish Pal, Armando Vargas-Palacios, Anantharaju Prasad, Martin Wilby, Deborah Stocken
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引用次数: 0

Abstract

Background: Posterior cervical foraminotomy and anterior cervical discectomy are routinely used operations to treat cervical brachialgia, although definitive evidence supporting superiority of either is lacking.

Objective: The primary objective was to investigate whether or not posterior cervical foraminotomy is superior to anterior cervical discectomy in improving clinical outcome.

Design: This was a Phase III, unblinded, prospective, United Kingdom multicentre, parallel-group, individually randomised controlled superiority trial comparing posterior cervical foraminotomy with anterior cervical discectomy. A rapid qualitative study was conducted during the close-down phase, involving remote semistructured interviews with trial participants and health-care professionals.

Setting: National Health Service trusts.

Participants: Patients with symptomatic unilateral cervical brachialgia for at least 6 weeks.

Interventions: Participants were randomised to receive posterior cervical foraminotomy or anterior cervical discectomy. Allocation was not blinded to participants, medical staff or trial staff. Health-care use from providing the initial surgical intervention to hospital discharge was measured and valued using national cost data.

Main outcome measures: The primary outcome measure was clinical outcome, as measured by patient-reported Neck Disability Index score 52 weeks post operation. Secondary outcome measures included complications, reoperations and restricted American Spinal Injury Association score over 6 weeks post operation, and patient-reported Eating Assessment Tool-10 items, Glasgow-Edinburgh Throat Scale, Voice Handicap Index-10 items, PainDETECT and Numerical Rating Scales for neck and upper-limb pain over 52 weeks post operation.

Results: The target recruitment was 252 participants. Owing to slow accrual, the trial closed after randomising 23 participants from 11 hospitals. The qualitative substudy found that there was support and enthusiasm for the posterior cervical FORaminotomy Versus Anterior cervical Discectomy in the treatment of cervical brachialgia trial and randomised clinical trials in this area. However, clinical equipoise appears to have been an issue for sites and individual surgeons. Randomisation on the day of surgery and processes for screening and approaching participants were also crucial factors in some centres. The median Neck Disability Index scores at baseline (pre surgery) and at 52 weeks was 44.0 (interquartile range 36.0-62.0 weeks) and 25.3 weeks (interquartile range 20.0-42.0 weeks), respectively, in the posterior cervical foraminotomy group (n = 14), and 35.6 weeks (interquartile range 34.0-44.0 weeks) and 45.0 weeks (interquartile range 20.0-57.0 weeks), respectively, in the anterior cervical discectomy group (n = 9). Scores appeared to reduce (i.e. improve) in the posterior cervical foraminotomy group, but not in the anterior cervical discectomy group. The median Eating Assessment Tool-10 items score for swallowing was higher (worse) after anterior cervical discectomy (13.5) than after posterior cervical foraminotomy (0) on day 1, but not at other time points, whereas the median Glasgow-Edinburgh Throat Scale score for globus was higher (worse) after anterior cervical discectomy (15, 7, 6, 6, 2, 2.5) than after posterior cervical foraminotomy (3, 0, 0, 0.5, 0, 0) at all postoperative time points. Five postoperative complications occurred within 6 weeks of surgery, all after anterior cervical discectomy. Neck pain was more severe on day 1 following posterior cervical foraminotomy (Numerical Rating Scale - Neck Pain score 8.5) than at the same time point after anterior cervical discectomy (Numerical Rating Scale - Neck Pain score 7.0). The median health-care costs of providing initial surgical intervention were £2610 for posterior cervical foraminotomy and £4411 for anterior cervical discectomy.

Conclusions: The data suggest that posterior cervical foraminotomy is associated with better outcomes, fewer complications and lower costs, but the trial recruited slowly and closed early. Consequently, the trial is underpowered and definitive conclusions cannot be drawn. Recruitment was impaired by lack of individual equipoise and by concern about randomising on the day of surgery. A large prospective multicentre trial comparing anterior cervical discectomy and posterior cervical foraminotomy in the treatment of cervical brachialgia is still required.

Trial registration: This trial is registered as ISRCTN10133661.

Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 21. See the NIHR Journals Library website for further project information.

颈前路椎间盘切除术与颈前路椎间孔切除术治疗颈臂痛:FORVAD随机对照试验。
背景:颈前路椎间盘切除术和颈前路椎间孔切除术是治疗颈腕痛的常规手术,尽管缺乏明确的证据支持两者的优越性。目的:研究颈前路椎间盘切除术在提高临床疗效方面是否优于颈前路椎间孔切除术。设计:这是一项III期、非盲、前瞻性、英国多中心、平行组、单独随机对照的优越性试验,比较颈前路椎间盘切除术和颈前路椎间孔切除术。在关闭阶段进行了一项快速定性研究,包括对试验参与者和医疗保健专业人员的远程半结构化访谈。设置:国家卫生服务信托基金。参与者:症状性单侧颈腕痛患者,持续时间至少6周。干预措施:参与者被随机分配接受颈前路椎间孔切除术或颈前路椎间盘切除术。分配并没有对参与者、医务人员或试验人员视而不见。从提供最初的手术干预到出院的医疗保健使用都是使用国家成本数据来衡量和评估的。主要结果指标:主要结果指标是临床结果,通过术后52周患者报告的颈部残疾指数评分来衡量。次要转归指标包括术后6周内的并发症、再次手术和美国脊髓损伤协会限制性评分,以及患者报告的术后52周内颈部和上肢疼痛的进食评估工具10项、格拉斯哥-爱丁堡喉咙量表、语音障碍指数10项、PainDETECT和数字评定量表。结果:目标招募252名参与者。由于积累缓慢,该试验在随机抽取来自11家医院的23名参与者后结束。定性亚研究发现,在治疗颈腕痛的试验和该领域的随机临床试验中,有人支持和热情支持颈后关节切开术与颈前椎间盘切除术。然而,临床平衡似乎一直是现场和个体外科医生的一个问题。在一些中心,手术当天的随机性以及筛查和接近参与者的过程也是关键因素。颈后孔切开术组(n=14)基线(术前)和52周时颈部残疾指数的中位数分别为44.0(四分位间距36.0-62.0周)和25.3周(四分位数间距20.0-42.0周),分别为35.6周(四分位间距34.0-44.0周)和45.0周(四分线间距20.0-57.0周),颈前路椎间盘切除术组(n=9)。颈椎后孔切除组的评分似乎有所降低(即改善),但颈椎前椎间盘切除组没有。在第1天,颈前路椎间盘切除术(13.5)后吞咽的进食评估工具-10项目得分中值高于(更差)颈前路椎间孔切除术(0)后吞咽,但在其他时间点没有,而在所有术后时间点,颈前路椎间盘切除术后(15,7,6,6,2,2.5)的球蛋白格拉斯哥-爱丁堡喉咙量表评分中值高于(更差)颈前路椎间孔切除术后的球蛋白评分中值(3,0,0,0.5,0)。术后6周内发生5例并发症,均发生在颈前路椎间盘切除术后。颈椎后孔切除术后第1天的颈部疼痛(数值评定量表-颈部疼痛评分8.5)比颈椎前椎间盘切除术后同一时间点的颈部疼痛更严重(数值评定表-颈部痛苦评分7.0)。提供初始手术干预的中位医疗费用为:颈椎后孔切开术2610英镑,颈椎前椎间盘中切除术4411英镑。结论:数据表明,颈后孔切开术具有更好的结果、更少的并发症和更低的成本,但试验招募缓慢且提前结束。因此,审判力量不足,无法得出确切结论。由于缺乏个体平衡和担心手术当天的随机化,招募受到影响。仍需进行一项大型前瞻性多中心试验,比较颈前路椎间盘切除术和颈前路椎间孔切开术治疗颈腕痛。试验注册:该试验注册为ISRCTN10133661。资助:该项目由美国国立卫生与保健研究所(NIHR)健康技术评估计划资助,并将在《健康技术评估》上全文发表;第27卷第21期。有关更多项目信息,请访问NIHR期刊图书馆网站。
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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来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
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