دورية أكاديمية
Safety and efficacy of second-generation all-suture anchors in labral tear arthroscopic repairs: prospective, multicenter, 1-year follow-up study
العنوان: | Safety and efficacy of second-generation all-suture anchors in labral tear arthroscopic repairs: prospective, multicenter, 1-year follow-up study |
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المؤلفون: | Andrew L. Wallace, MA, PhD, FFSEM, FRCS, FRACS, Emilio Calvo, MD, PhD, Jordi Ardèvol Cuesta, MD, Riccardo Lanzetti, MD, Gonzalo Luengo-Alonso, MD, PhD, FEBOT, ECFMG, Andrew S. Rokito, MD, Edwin E. Spencer, Jr, MD, Marco Spoliti, MD |
المصدر: | JSES International, Vol 8, Iss 4, Pp 763-768 (2024) |
بيانات النشر: | Elsevier, 2024. |
سنة النشر: | 2024 |
المجموعة: | LCC:Orthopedic surgery LCC:Diseases of the musculoskeletal system |
مصطلحات موضوعية: | Labral tear, Shoulder instability, Glenoid labrum, All-soft suture anchor, Shoulder repair, Arthroscopic repair, Orthopedic surgery, RD701-811, Diseases of the musculoskeletal system, RC925-935 |
الوصف: | Background: This study’s primary aim was to assess the safety and performance of second-generation all-soft suture anchors following arthroscopic labral tear repair. Methods: This prospective, multicenter study was conducted by 6 surgeons at 6 sites in Europe and the United States between November 2018 and August 2020. Patients who required shoulder arthroscopic repair, for a range of labral injuries, were treated with a second-generation all-soft suture anchor. The primary outcome was clinical success rate (percentage of patients without signs of failure and/or reintervention) at 6 months. Secondary outcomes included clinical success rate at 12 months, intraoperative anchor deployment success rate, and patient-reported outcomes (PROs) at 6 and 12 months, including visual analog scale (VAS) pain assessment, VAS satisfaction assessment, EQ-5D-5L Index Score, EQ-5D-5L VAS Health Score, Rowe Shoulder Score for Instability, American Shoulder and Elbow Surgeons score, and Constant-Murley Shoulder Score. Serious adverse events and serious adverse device effects were collected throughout the study. Results: Forty-one patients were enrolled (mean age, 28.2 years; 87.8% male, 12.2% female). Clinical success was achieved in 27/28 and 31/32 patients at 6 months and 12 months, respectively. Anchor deployment had a 100% success rate. Significant improvements over baseline were reported for all PROs except Constant-Murley Shoulder (6 months) and VAS Satisfaction Score (12 months). One patient experienced 1 serious adverse event and 1 patient experienced 1 serious adverse device effect. Conclusion: Second-generation all-soft suture anchors used in this study demonstrated a high clinical success rate, a favorable safety profile, and patients exhibited significant improvement in PROs. |
نوع الوثيقة: | article |
وصف الملف: | electronic resource |
اللغة: | English |
تدمد: | 2666-6383 |
العلاقة: | http://www.sciencedirect.com/science/article/pii/S2666638324001130Test; https://doaj.org/toc/2666-6383Test |
DOI: | 10.1016/j.jseint.2024.04.008 |
الوصول الحر: | https://doaj.org/article/6eae81f3397d415099a05fc6d692dca0Test |
رقم الانضمام: | edsdoj.6eae81f3397d415099a05fc6d692dca0 |
قاعدة البيانات: | Directory of Open Access Journals |
تدمد: | 26666383 |
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DOI: | 10.1016/j.jseint.2024.04.008 |