英国华威大学Andrew Metcalfe团队研究了肩峰下球囊垫片治疗无法修复的肩袖撕裂的疗效。2022年4月21日出版的《柳叶刀》杂志发表了这项成果。

新外科手术可能会对患者造成伤害，在广泛使用前应仔细评估。InSpace球囊（美国Stryker）是一种新型外科设备，用于治疗肩袖撕裂无法修复的患者。该研究旨在确定InSpace球囊对肩袖撕裂无法修复患者的有效性。

研究组在英国24家医院进行了一项双盲、组序贯、适应性随机对照试验，比较了关节镜下肩峰下间隙清创和肱二头肌肌腱切开术（仅清创组）与在相同手术基础上包括插入InSpace球囊（带器械清创组）的疗效。参与者的肩袖撕裂无法修复，保守治疗无法解决，他们的症状需要手术治疗。

在术中确认合格后，将参与者按1:1随机分组。参与者和评估者均双盲。通过在两种手术中使用相同的切口，一致的手术记录，并提供一致的康复计划来实现双盲，而不考虑小组分配。

主要结局是12个月时的牛津肩关节评分。使用来自早期和晚期时间点数据的预试验模拟来确定两个中期分析的停止边界。主要分析基于改良的意向治疗基础，并根据计划的中期分析进行校正。

2018年6月1日至2020年7月30日，研究组对385人进行了资格评估，其中317人符合资格。249人（79%）同意纳入研究。117名参与者被随机分配到治疗组，其中仅清创组61名，带器械清创组56名。在第一次中期分析中，达到了预先确定的停止边界，并停止招募参与者。

43%的参与者为女性，57%为男性。研究组获得了114名（97%）参与者的主要结果数据。12个月时，仅清创组的平均牛津肩部评分为34.3分，而带器械清创组为30.3分，组间差异显著，对照组益处更大。两组之间的不良事件没有差异。

研究结果表明，在这个有效性适应性试验设计中，仅清创组临床获益更大。研究组不推荐InSpace气囊治疗无法修复的肩袖撕裂。

附：英文原文

Title: Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial

Author: Andrew Metcalfe, Helen Parsons, Nicholas Parsons, Jaclyn Brown, Josephine Fox, Elke Gemperlé Mannion, Aminul Haque, Charles Hutchinson, Rebecca Kearney, Iftekhar Khan, Tom Lawrence, James Mason, Nigel Stallard, Martin Underwood, Stephen Drew, Andrew Metcalfe, Helen Parsons, Nicholas Parsons, Azra Arif, Susanne Arnold, Gev Bhabra, Jaclyn Brown, Sunayna Bora, Howard Bush, Stephen Drew, Jo Fox, Elke Gemperlé Mannion, Aminul Haque, Charles Hutchinson, Ceri Jones, Rebecca Kearney, Iftekhar Khan, Thomas Lawrence, James Mason, Kerri McGowan, Chetan Modi, Bushra Rahman, Usama Rahman, Maria Ramirez, Marta Spocinska, Nigel Stallard, Joanna Teuke, Varjithan Thayalan, Sumayyah Ul-Rahman, Aparna Viswanath, Martin Underwood, Aminul Haque, Iftekhar Khan, James Mason, Helen Parsons, Nicholas Parsons, Nigel Stallard, Iain Packham, Elizabeth Barnett, Rian Witham, Mark Crowther, Richard Murphy, Katherine Coates, Josephine Morley, Stephen Barnfield, Sukhdeep Gill, Alistair Jones, Ruth Halliday, Sarah Dunn, James Fagg, Peter Dacombe, Rajesh Nanda, Deborah Wilson, Lesley Boulton, Raymond Liow, Richard Jeavons, Andrea Meddes, Niel Kang, Leila Dehghani, Aileen Nacorda, Anuj Punnoose, Nicholas Ferran, Gbadebo Adewetan, Temi Adedoyin, Arun Pall, Matthew Sala, Tariq Zaman, Richard Hartley, Charif a-Sayyad, Luke Vamplew, Elizabeth Howe, Norbert Bokor, Steve Corbett, Robert Moverley, Elise Cox, Oliver Donaldson, Michael Jones, Diane Wood, Jess Perry, Alison Lewis, Linda Howard, Kate Beesley, Luke Harries, Ahmed Elmorsy, Katherine Wilcocks, Kate Shean, Sarah Diment, Helen Pidgeon, Victoria King, Soren Sjolin, Angharad Williams, Joanne Kellett, Lora Young, Michael Dunne, Tom Lockwood, Mark Curtis, Nashat Siddiqui,, India Mckenley, Sarah Morrison, Charlotte Morrison, Tracey OBrien, Isabel Bradley, Kenneth Lambatan, Cormac Kelly, Charlotte Perkins, Teresa Jones, Tessa Rowlands, Dawn Collins, Claire Nicholas, Claire Birch, Julie Lloyd -Evans, Pouya Akhbari, Jefin Jose Edakalathu, Campbell Hand, Andy Cole

Issue&Volume: 2022-04-21

Abstract:

Background

New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears.

Methods

We conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Participants and assessors were masked to group assignment. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. The primary outcome was the Oxford Shoulder Score at 12 months. Pre-trial simulations using data from early and late timepoints informed stopping boundaries for two interim analyses. The primary analysis was on a modified intention-to-treat basis, adjusted for the planned interim analysis. The trial was registered with ISRCTN, ISRCTN17825590.

Findings

Between June 1, 2018, and July 30, 2020, we assessed 385 people for eligibility, of which 317 were eligible. 249 (79%) people consented for inclusion in the study. 117 participants were randomly allocated to a treatment group, 61 participants to the debridement only group and 56 to the debridement with device group. A predefined stopping boundary was met at the first interim analysis and recruitment stopped with 117 participants randomised. 43% of participants were female, 57% were male. We obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with device group (mean difference adjusted for adaptive design –4·2 [95% CI –8·2 to –0·26];p=0·037) favouring control. There was no difference in adverse events between the two groups.

Interpretation

In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears.

DOI: 10.1016/S0140-6736(22)00652-3

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00652-3/fulltext