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Randomized Controlled Trial
. 2022 May 21;399(10339):1954-1963.
doi: 10.1016/S0140-6736(22)00652-3. Epub 2022 Apr 21.

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

Andrew Metcalfe  1 , Helen Parsons  2 , Nicholas Parsons  2 , Jaclyn Brown  2 , Josephine Fox  3 , Elke Gemperlé Mannion  2 , Aminul Haque  2 , Charles Hutchinson  4 , Rebecca Kearney  4 , Iftekhar Khan  2 , Tom Lawrence  5 , James Mason  2 , Nigel Stallard  2 , Martin Underwood  4 , Stephen Drew  5 ; START:REACTS team
Collaborators, Affiliations
Free article
Randomized Controlled Trial

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

Andrew Metcalfe et al. Lancet. .
Free article

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.

Funding: Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership.

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Conflict of interest statement

Declaration of interests Outside of this study, the authors report no personal financial conflict of interest with Stryker or any other related commercial organisation. AM, HP, EGM, CH, JM, and MU are coinvestigators on two other National Institute for Health and Care Research (NIHR)-funded trials (RACER-Knee and RACER-Hip, AM leads RACER-Knee), for which Stryker also fund treatment costs and some imaging costs. As with the presented study, the full independence of the study team is protected by legal agreements. AM, HP, NP, EGM, AH, CH, RK, IK, JM, NS, and MU all work on other NIHR-funded studies. CH, RK, JM and MU are or have been members of funding panels in NIHR, although not on the Efficacy and Mechanism Evaluation programme. RSK is chair of the NIHR Research for Patient Benefit board, a paid position in NIHR but unrelated to the trial. MU was until March, 2021, an NIHR Senior Investigator; until March, 2020, he was an editor of the NIHR journal series and a member of the NIHR Journal Editors Group, for which he received a fee. SD Held an Educational Consultancy Contract with Wright for the past 36 months for lecturing on the Aequalis Shoulder Re-placement System. Wright was acquired by Stryker in 2020.

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