Low Incidence of Adverse Events of a Novel Self‐Tensioning No. 2 Round Suture in Rotator Cuff Repair: An <scp>IDEAL</scp> Stage 2a Registry Cohort Analysis
Bibliographic record
Abstract
BACKGROUND: Despite technical and material improvements in rotator cuff repair, clinical and radiological failure remains common. Following suture fixation, tension and footprint compression decrease from time zero. A novel suture has been designed to shorten when submerged in liquid to maintain tension and increase repair construct security. The aim of this study was to assess the safety and clinical outcomes (IDEAL 2a assessment) in patients receiving rotator cuff repair with the self-tensioning suture with a minimum of 12 months follow up. Clinical registries allow early identification of outlier or poorly performing prosthesis with prevention of avoidable complications. METHODS: A cohort analysis was performed utilizing patients from the PRULO (Patient Reported Outcomes in Upper Limb Surgery) registry. All patients with the suture of interest who underwent a rotator cuff repair with 12 months follow up were included. Results included patient reported outcome scores: Quick Disability of the Arm, Shoulder and Hand (QuickDASH), and the Western Ontario Rotator Cuff Index (WORC) and complications. Patient reported outcome measures (PROMs) were analyzed using multiple imputation and a linear model to assess changes over 12 months follow up. RESULTS: A cohort of 255 patients was included for analysis. At 12 months follow up, median scores for QuickDASH decreased by 36 and WORC increased by 41, both of which surpass the minimum clinically important difference. Our observed rates of complications included: Infection 2.4%, stiffness/capsulitis 13%, and retear 12%. Complication rates and functional improvements were similar to other studies. These results suggest the suture is safe and adequately effective for ongoing clinical use and further study. CONCLUSION: The novel suture demonstrated comparable safety and efficacy profiles, with outcomes similar to those published in the literature. This study suggests this novel suture is safe and does not seem to produce unique complications. Further research is warranted to specifically investigate clinical efficacy in the longer term. TRIAL REGISTRATION: ACTRN12619000770167.
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 | 0.002 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".