Evidence map›Paper›PMID 41094412›Full record

ArticleBMC musculoskeletal disorders2025

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.

Corey Scholes, Manaal Fatima, Cooper Moody, Kevin Eng, Richard S Page

Abstract read
In one paragraph

Article in BMC musculoskeletal disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Corey ScholesEBM Analytics, Sydney, NSW, Australia.
Manaal FatimaEBM Analytics, Sydney, NSW, Australia.
Cooper MoodyDepartment of Orthopaedics, Barwon Health, Geelong, VIC, Australia.
Kevin EngDepartment of Orthopaedics, Barwon Health, Geelong, VIC, Australia.ORCID http://orcid.org/0000-0003-4651-6793
Richard S PageDepartment of Orthopaedics, Barwon Health, Geelong, VIC, Australia. richard.page@deakin.edu.au.ORCID http://orcid.org/0000-0002-2225-7144

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPoly-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.

methodsA 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.

resultsA 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.

conclusionsThis 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 registrationEthics 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.

Indexed as

ArthroscopyBiocompatible MaterialsRotator Cuff InjuriesSuture AnchorsAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedNew ZealandPatient Reported Outcome MeasuresPostoperative ComplicationsProspective StudiesRegistriesBiocompatible MaterialsBiocompositeIDEALPatient-reported outcomesPoly-lactic co-glycolic acidRotator cuff repairTricalcium phosphate

Identifiers

PMID41094412
PMCPMC12522642

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.