Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial
Authors: 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 O'Brien, 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, Debbie Prince, Kerry Thorpe, Louise Rooke, Maria Baggot, Matt Morris, Dima Ivanova, David Baker, Tim Matthews, Jessica Falatoori, Heather Jarvis, Debbie Jones, Matthew Williams, Richard Evans, Huw Pullen, Gemma Hodkinson, Nicola Vannet, Alison Davey, Emma Poyser, Angela Hall, Hemang Mehta, Devi Prakash Tokola, Clare Connor, Caroline Jordan, Owain Ennis, Zohra Omar, Tracy Lewis, Angharad Lisa Owen, Andrew Morgan, Ravi Ponnada, Waheeb Al-Azzani, Carolyn Williams, Liam Knox, Harvinder Singh, Tracy Lee, Kathryn Robinson, Dileep Kumar, Alison Armstrong, Addie Majed, Mark Falworth, David Butt, Deborah Higgs, Will Rudge, Ben Hughes, Esther Hanison, Deirdre Brooking, Amit Patel, Andrew Symonds, Jenifer Gibson, Rodney Santiago, David Barlow, Joanne Lennon, Christopher Smith, Jane Hall, Emily Griffin, Rebecca Lear, William Thomas, David Rose, Janet Edkins, Helen Samuel, Hagen Jahnich, John Geoghegan, Ben Gooding, Siobhan Hudson, Jess Nightingale, Madhavan Papanna, Tom Briggs, Rebecca Pugh, Amy Neal, Lisa Warrem, Veronica Maxwell, Robert Chadwick, Thomas Jaki, Loretta Davies, Stephen Gwilym, Rod Taylor, Geoffrey Abel, John Graham, Christopher Littlewood, Angus Wallace, Anthony Howard
Journal: The Lancet (2022)

BackgroundNew 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.MethodsWe 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.FindingsBetween 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.InterpretationIn 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.FundingEfficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership