Trial reportBMC musculoskeletal disorders2020
The use of a synthetic shoulder patch for large and massive rotator cuff tears - a feasibility study.
Trial report in BMC musculoskeletal disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- A meta-analysis of the outcomes of large to massive rotator cuff tears treated with direct repair, graft augmentation, or superior capsular reconstruction.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2025Pooled it
- Recent Updates on Allograft Selection for Reconstruction of Massive Rotator Cuff Tears.Clinics in orthopedic surgery · 2026Review
- BicepBrace biceps tendon augmentation improves outcomes one year following surgery.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2025Article
- Commercial Biomaterial-Based Products for Tendon Surgical Augmentation: A Scoping Review on Currently Available Medical Devices.Journal of functional biomaterials · 2025Review
- New Three Dimensional-Printed Polyethylene Terephthalate Glycol Liners for Hip Joint Endoprostheses: A Bioactive Platform for Bone Regeneration.Materials (Basel, Switzerland) · 2025Article
- The Clinical Application of Gel-Based Composite Scaffolds in Rotator Cuff Repair.Gels (Basel, Switzerland) · 2024Review
- Patient-reported outcome tools and baseline scores vary by country and region for arthroscopic repair of massive rotator cuff tears: a systematic review.JSES reviews, reports, and techniques · 2023Article
- Patch augmentation does not provide better clinical outcomes than arthroscopic rotator cuff repair for large to massive rotator cuff tears.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2022Article
- Use of Gracile and semi-tendinosus tendons (GRAST) for the reconstruction of irreparable rotator cuff tears.BMC musculoskeletal disorders · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundThe aim of this study was to explore the feasibility of using a non-absorbable biocompatible polyester patch to augment open repair of massive rotator cuff tears (Patch group) and compare outcomes with other treatment options (Non-patch group).
methodsParticipants referred to orthopaedic clinics for rotator cuff surgery were recruited. Choice of intervention (Patch or Non-patch) was based on patient preference and intra-operative findings. Oxford Shoulder Score (OSS), Shoulder Pain and Disability Index (SPADI), and Constant score were completed at baseline and 6 months. Shoulder MRI was performed at baseline and 6 months to assess fat fraction and Goutallier classification pre- and post- treatment. Feasibility outcomes (including retention, consent and missing data) were assessed.
resultsSixty-eight participants (29 in the Patch group, 39 in Non-patch group) were included (mean age 65.3 years). Conversion to consent (92.6%), missing data (0% at baseline), and attrition rate (16%) were deemed successful feasibility endpoints. There was significant improvement in the Patch group compared to Non-patch at 6 months in OSS (difference in medians 9.76 (95% CI 2.25, 17.29) and SPADI: 22.97 (95% CI 3.02, 42.92), with no substantive differences in Constant score. The patch group had a higher proportion of participants improving greater than MCID for OSS (78% vs 62%) and SPADI (63% vs 50%) respectively. Analysis of the 48 paired MRIs demonstrated a slight increase in the fat fraction for supraspinatus (53 to 55%), and infraspinatus (26 to 29%) at 6 months. These differences were similar and in the same direction when the participants were analysed by treatment group. The Goutallier score remained the same or worsened one grade in both groups equally.
conclusionsThis study indicates that a definitive clinical trial investigating the use of a non-absorbable patch to augment repair of massive rotator cuff tears is feasible. In such patients, the patch has the potential to improve shoulder symptoms at 6 months.
trial registrationISRCTN, ISRCTN79844053, Registered 15th October 2014 (retrospectively registered).
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Registered trials
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.