Stage 2a IDEAL evaluation of a third-generation biocomposite suture anchor in arthroscopic rotator cuff repair: subgroup cohort analysis of the PRULO registry with 12-month follow up
Bibliographic record
Abstract
BACKGROUND: Poly-lactic co-glycolide with tricalcium phosphate (PLGA)/β-TCP is both bioactive and biodegradable, and is considered a third generation biomaterial for suture anchors. This study aims to describe the incidence of adverse events and the trajectory of patient-reported outcomes up to 12 months follow up in patients undergoing rotator cuff repair with this type of anchor. METHODS: A sub-group analysis of a prospective registry of a regional private clinic embedded in an orthopaedic clinic was conducted. This study is registered on the Australian New Zealand Clinical Trials Registry (ACTRN12619000770167) with date 23/05/2019. Patients undergoing surgery from Jun-2020 to Mar-2024 with the Healix Advance BR were identified and data on patient demographics, treatment details, complications and adverse events, as well as patient-reported outcome measures (PROMs) were retrieved. Summary statistics were generated for patient characteristics and PROMs analysed using multiple imputation and mixed-effects linear models to assess changes between baseline and 12 month follow up. RESULTS: A consecutive cohort of 68 cases receiving the anchor of interest was included for analysis. Complications were recorded in six cases (8.8%, 95%CI 3.6-18.9), presenting as postoperative capsulitis/stiffness (N = 3), persistent shoulder pain (N = 1), a case of hemi-diaphragm palsy and a case of complex regional pain syndrome in the hand. No infections or reoperations were encountered in this series. The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores improved significantly from 42 (IQR 32-52) preoperatively to 5 (IQR 2-14) at 12 months. Western Ontario Rotator Cuff (WORC Index) scores improved from 35 (IQR 21-54) preoperatively to 88 (IQR 70-95) at 12 months. CONCLUSIONS: This study found a low incidence of adverse events, no requirement for reoperation or revision, and favourable recovery of patient-reported outcomes in patients treated with arthroscopic rotator cuff repair with a third-generation biocomposite suture anchor at up to 12 months follow up. TRIAL REGISTRATION: Ethics approval for the Patient Registry of Upper Limb Pathology Outcomes (PRULO) has been provided by the Human Research Ethics Committee at Barwon Health (Project ID 49184, Reference 19/70). This study is registered on the Australian New Zealand Clinical Trials Registry (ACTRN12619000770167) with date 23/05/2019.
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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 | 0.007 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 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".