{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T13:43:35Z","timestamp":1792158215932,"version":"4.4.0"},"reference-count":34,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2025,3,28]],"date-time":"2025-03-28T00:00:00Z","timestamp":1743120000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,3,28]],"date-time":"2025-03-28T00:00:00Z","timestamp":1743120000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"NIHR Evaluation, Trials and Studies Co-ordinating Centre","award":["16\/61\/18"],"award-info":[{"award-number":["16\/61\/18"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Am J Sports Med"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>The 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Design:<\/jats:title>\n                    <jats:p>Randomized controlled trial; Level of evidence, 1.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Eligible 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Recruitment 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, \u20137.9 to 0.4;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .08). The Western Ontario Rotator Cuff score (mean difference, \u201310.1; 95% CI, \u201319.5 to \u22120.8;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .04) and Patient Global Impression of Change (odds ratio, 0.4; 95% CI, 0.2 to 0.8;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .015) were found to significantly favor debridement only. The EQ-5D-5L (mean difference, \u22120.009; 95% CI, \u22120.107 to 0.088;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .85) and satisfaction scores (odds ratio, 0.6; 95% CI, 0.3 to \u22121.2;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .14) were not significantly different. Complications were evenly matched between groups over 24 months.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Participants 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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03635465251326891","type":"journal-article","created":{"date-parts":[[2025,3,29]],"date-time":"2025-03-29T15:38:14Z","timestamp":1743262694000},"page":"1291-1298","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":12,"title":["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)"],"prefix":"10.1177","volume":"53","author":[{"given":"Aminul","family":"Haque","sequence":"first","affiliation":[{"name":"Warwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Parsons","sequence":"additional","affiliation":[{"name":"Warwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nick","family":"Parsons","sequence":"additional","affiliation":[{"name":"Warwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Mason","sequence":"additional","affiliation":[{"name":"Warwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iftekhar","family":"Khan","sequence":"additional","affiliation":[{"name":"Warwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nigel","family":"Stallard","sequence":"additional","affiliation":[{"name":"Warwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Underwood","sequence":"additional","affiliation":[{"name":"Warwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Hutchinson","sequence":"additional","affiliation":[{"name":"University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Lawrence","sequence":"additional","affiliation":[{"name":"University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steve","family":"Drew","sequence":"additional","affiliation":[{"name":"University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Kearney","sequence":"additional","affiliation":[{"name":"Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Metcalfe","sequence":"additional","affiliation":[{"name":"Warwick Clinical Trials Unit, Medical School, University of Warwick, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,3,28]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/0168-8510(96)00822-6"},{"key":"e_1_3_2_3_2","unstructured":"Constant Score Manual. 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