Comparison of the perceived effectiveness, efficiency and ergonomics of the Safescraper vs Bone Gainer in a non-randomised clinical cadaver-based usability pilot study.

چکیده اصلی

PURPOSE: Autogenous bone chips are a key component of augmentative and periodontal surgical reconstruction. The choice of an appropriate bone scraper can influence efficiency, effectiveness and user satisfaction. The aim of this non-randomised clinical cadaver-based usability pilot study was to compare the Safescraper (META, Reggio Emilia, Italy) with the newly developed Bone Gainer (PalDent Tech, Berlin, Germany) in terms of usability. MATERIALS AND METHODS: In collaboration with the Department of Oral and Cranio-Maxillofacial Surgery at the University Hospital Basel, 16 users with varying levels of experience evaluated the performance of both instruments on human cadaver heads in the posterior maxilla during a lateral fenestrating antrostomy. The summative evaluation used a 25-item Likert questionnaire covering the domains of ergonomics, perceived effectiveness, perceived efficiency, satisfaction and overall assessment. Paired Wilcoxon tests were used and effect sizes (r) were calculated. RESULTS: The Bone Gainer was rated significantly better than the Safescraper across most domains (P 0.01), except for the criteria 'can be used without instruction' and 'initial blade sharpness'. Effect sizes were consistently large (r ≈ 0.82 to 0.86). CONCLUSIONS: The results indicate that the choice of instrument may significantly influence perceived usability and subjective user experience. Because this is a cadaver pilot study without clinical endpoints, its applicability to everyday patient care remains limited. Future studies should validate the observed differences in clinical settings and assess their significance for surgical outcomes. CONFLICT-OF-INTEREST STATEMENT: The clinical study was conducted by Walid El-Khatib. He is the principal shareholder and major owner of PalDent Tech, the manufacturer of the Bone Gainer, which represents a potential conflict of interest. Co-authors Philipp Plugmann, Florian Thieringer and Lukas Seifert did not benefit financially or personally from their institutional affiliation or from conducting the study. There are no other financial or personal ties that could compromise the independence of the research or the interpretation of the results. All potential conflicts of interest have been disclosed.

ترجمه فارسی چکیده

هدف این مطالعه عملی بالینی غیرتصادفی و آزمایشی بر روی جسد انسان، مقایسه ابزار Safescraper (META، ایتالیا) و Bone Gainer (PalDent Tech، آلمان) از نظر کاربردپذیری بود. ۱۶ کاربر با سطوح مختلف تجربه، عملکرد هر دو ابزار را در جمجمه‌های انسانی در حفره پسین فک بالا در حین عمل جراحی فنستراتور لاترال ارزیابی کردند. ارزیابی جمعی با پرسشنامه لیکرت ۲۵ آیتمی شامل حوزه‌های ارگونومی، اثربخشی، کارایی، رضایت و ارزیابی کلی انجام شد. آزمون‌های جفت ویلکاکسون استفاده شد و اندازه‌های اثر محاسبه گردید. Bone Gainer در اکثر حوزه‌ها به طور معناداری بهتر از Safescraper ارزیابی شد (P < 0.01)، به جز معیارهای 'قابل استفاده بدون دستورالعمل' و 'شکستگی اولیه تیغه'. اندازه‌های اثر همواره بزرگ بودند (r ≈ 0.82 تا 0.86). نتیجه‌گیری: نتایج نشان می‌دهد که انتخاب ابزار ممکن است به طور معناداری بر کاربردپذیری و تجربه کاربری تأثیر بگذارد. از آنجا که این یک مطالعه آزمایشی بر روی جسد انسان بدون نقاط پایانی بالینی است، کاربرد آن در مراقبت روزمره بیماران محدود باقی می‌ماند.

متن کامل اصلی