A MULTICENTRE RANDOMISED CLINICAL TRIAL COMPARING ETAC AND OPEN INFERIOR CAPSULAR SHIFT AT 2 YEARS POST-OPERATIVELY
Bibliographic record
Abstract
Purpose Electrothermal arthroscopic capsulorrhaphy (ETAC) was a technology introduced for orthopaedic surgery without good scientific clinical evidence supporting its use. This multicentre randomized clinical trial provides the scientific clinical evidence comparing ETAC to Open Inferior Capsular Shift (ICS), by measuring disease-specific quality of life at 2-years post-operatively, in patients with shoulder instability due to capsular redundancy. Method Fifty-four subjects (37 females and 17 males; mean age 23.3 years (SD = 6.9; 15–44 years) with multidirectional instability (MDI) or multidirectional laxity with antero-inferior instability (MDL-AII) were randomized intra-operatively to ETAC (n = 28) or Open ICS (n = 26) using concealed envelopes, computer-generated, variable block randomization with stratification by surgeon and type of instability. Outcomes were measured at baseline, 3 and 6 months, 1 and 2 years. The Western Ontario Shoulder Instability (WOSI) Index is a quality of life outcome measure that is scored on a visual analog scale from 0 to 100, where a higher score represents better quality of life. Two functional assessments included the American Shoulder and Elbow Society (ASES) Score and the Constant Score. Post-operative recurrent instability and surgical time were also measured. Analyses included ANOVA of repeated measures with Bonferroni adjustments for multiple comparisons, Chi-square and independent t-tests (p Results At 2-years post-operatively, mean WOSI scores were not statistically different between the groups (p=0.61): ETAC = 74 (SD = 24; 95% CI = 64 84); Open ICS = 77 (SD = 20; 95% CI = 68 86). There was no difference between groups for mean ASES scores (p=0.34): ETAC = 81 (SD = 20; 95% CI = 73 90); Open ICS = 87 (SD = 18; 95% CI = 79 95), mean Constant scores (p = 0.35): ETAC = 83 (SD = 7; 95% CI = 80 86); Open ICS = 85 (SD = 11; 95% CI = 80 − 90), and recurrent instability (p = 0.41): ETAC = 2; Open ICS = 4. Mean surgical time was 23 minutes for ETAC and 59 minutes for Open ICS (p = 0.00). Three subjects (1 ETAC, 2 Open ICS) had stiff shoulders; however, no major complications were observed. Conclusion Patient outcomes improved from baseline to all follow-up periods. There was no difference between the ETAC and Open ICS groups in quality of life, functional outcomes, and recurrent instability at 2 years post-operatively.
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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 | 0.004 | 0.008 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 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".