Evidence map›Paper›PMID 40156172›Full record

Trial reportThe American journal of sports medicine2025

Two-Year Follow-up of a Group-Sequential, Multicenter Randomized Controlled Trial of a Subacromial Balloon Spacer for Irreparable Rotator Cuff Tears of the Shoulder (START:REACTS).

Aminul Haque, Helen Parsons, Nick Parsons, James Mason, Iftekhar Khan, Nigel Stallard, Martin Underwood, Charles Hutchinson, Tom Lawrence, Steve Drew and 2 more

Abstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The American journal of sports medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Aminul HaqueWarwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK.
Helen ParsonsWarwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK.
Nick ParsonsWarwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK.
James MasonWarwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK.
Iftekhar KhanWarwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK.
Nigel StallardWarwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK.
Martin UnderwoodWarwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK.
Charles HutchinsonUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
Tom LawrenceUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
Steve DrewUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
Rebecca KearneyBristol Medical School, University of Bristol, Bristol, UK.
Andrew MetcalfeWarwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe best management of irreparable rotator cuff tears remains uncertain, with multiple new techniques introduced over the past 2 decades. Two options for treatment are arthroscopic debridement and biceps tenotomy, or the subacromial balloon spacer. Early trial results favored the former option, but the 2-year results have not yet been reported. PURPOSE: To report the 2-year follow-up outcomes of the START:REACTS trial, investigating the use of a subacromial balloon spacer for irreparable rotator cuff tears of the shoulder. STUDY

designRandomized controlled trial; Level of evidence, 1.

methodsEligible participants had an irreparable rotator cuff tear, intrusive symptoms requiring surgery, and previous unsuccessful nonoperative care. Participants were randomized 1:1 to debridement of the subacromial space with biceps tenotomy (debridement only) or the same procedure with the addition of the subacromial balloon spacer (debridement with device). The 12-month primary outcome was previously reported; this article presents the 24-month results. Linear regression models were used to analyze the 24-month data.

resultsRecruitment stopped early at the preplanned interim analysis, with 117 participants in the trial. A total of 99 (85%) participants out of 117 were followed up to 24 months. At 24 months, a significant difference in the Oxford Shoulder Score was not found (95% CI, -7.9 to 0.4;

conclusionParticipants continued to show better results in the debridement-only group compared with the group who had debridement with the InSpace balloon. Therefore, we do not recommend the subacromial balloon spacer for the treatment of irreparable rotator cuff tears.

Indexed as

DebridementRotator Cuff InjuriesAgedArthroscopyFemaleFollow-Up StudiesHumansMaleMiddle AgedTenotomyTreatment Outcomerandomized control trialrotator cuffshouldersubacromial space

Identifiers

PMID40156172
PMCPMC12044206

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.