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)
Bibliographic record
Abstract
Background: 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. 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 Design: Randomized controlled trial; Level of evidence, 1. Methods: 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. Results: 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, –7.9 to 0.4; P = .08). The Western Ontario Rotator Cuff score (mean difference, –10.1; 95% CI, –19.5 to −0.8; P = .04) and Patient Global Impression of Change (odds ratio, 0.4; 95% CI, 0.2 to 0.8; P = .015) were found to significantly favor debridement only. The EQ-5D-5L (mean difference, −0.009; 95% CI, −0.107 to 0.088; P = .85) and satisfaction scores (odds ratio, 0.6; 95% CI, 0.3 to −1.2; P = .14) were not significantly different. Complications were evenly matched between groups over 24 months. Conclusion: 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.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.012 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".