دورية أكاديمية
أعرض في EDS

Development of an in vitro test method to simulate intra-operative impaction loading on lumbar intervertebral body fusion devices.

التفاصيل البيبلوغرافية
العنوان: Development of an in vitro test method to simulate intra-operative impaction loading on lumbar intervertebral body fusion devices.
المؤلفون: Palepu V; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Applied Mechanics, Silver Spring, MD 20993, USA. Electronic address: Vivek.Palepu@fda.hhs.gov., Peck JH; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of Orthopedic Devices (OHT6), Division of Spinal Devices (DHT6B), Silver Spring, MD 20993, USA., Cadel ES; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Applied Mechanics, Silver Spring, MD 20993, USA., Parikh AR; Oak Ridge Institute for Science and Education, Oak Ridge, TN, USA., Wagner SC; Walter Reed National Military Medical Center, Department of Orthopaedics, Bethesda, MD 20889, USA., Fredericks DR Jr; Walter Reed National Military Medical Center, Department of Orthopaedics, Bethesda, MD 20889, USA., Helgeson MD; Walter Reed National Military Medical Center, Department of Orthopaedics, Bethesda, MD 20889, USA., Dmitriev AE; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Applied Mechanics, Silver Spring, MD 20993, USA.
المصدر: Journal of biomechanics [J Biomech] 2021 May 24; Vol. 121, pp. 110412. Date of Electronic Publication: 2021 Apr 05.
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.
اللغة: English
بيانات الدورية: Publisher: Elsevier Science Country of Publication: United States NLM ID: 0157375 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2380 (Electronic) Linking ISSN: 00219290 NLM ISO Abbreviation: J Biomech Subsets: MEDLINE
أسماء مطبوعة: Original Publication: New York ; Oxford : Elsevier Science
مواضيع طبية MeSH: Intervertebral Disc* , Spinal Fusion*, In Vitro Techniques ; Lumbar Vertebrae/surgery ; Lumbosacral Region ; Prostheses and Implants
مستخلص: Intervertebral body fusion devices (IBFDs) are commonly used in the treatment of various spinal pathologies. Intra-operative fractures of polyether-ether-ketone (PEEK) implants have been reported in the literature and to the FDA as device-related adverse events. The device and/or implant inserter failures typically occur during device impaction into the disc space and require implant removal and replacement. These additional steps may cause further complications along with increased surgical time and cost. Currently, there are no standardized test methods that evaluate clinically relevant impaction loading conditions on IBFDs. This study aims to develop an in vitro test method that would evaluate implant resistance to failure during intra-operative impaction. To achieve this, (1) surgical implantations of IBFDs were simulated in nine lumbar cadaver specimens by three different orthopedic spine surgeons (n = 3/surgeon). Impact force and mallet speed data were acquired for each surgeon. (2) Based on the acquired surgeon data, a benchtop mechanical test setup was developed to differentiate between two TLIF IBFD designs and two inserter designs (for a total of four IBFD-inserter combinations) under impaction loading. During implant insertion, impact force measurements indicated that lumbar IBFDs are subjected to high energy forces that may exceed their mechanical strength. Our test method successfully replicated clinically-relevant loading conditions and was effective at differentiating failure parameters between different implant and inserter instrument designs. The mechanical test method developed shows promise in its ability to assess impaction resistance of IBFD/inserter designs and evaluate potential risks of device failure during intraoperative loading.
(Published by Elsevier Ltd.)
فهرسة مساهمة: Keywords: Impaction; Insertion; Intra-operative fractures; Lumbar intervertebral body fusion device; Spinal cage fracture; Spinal fusion
تواريخ الأحداث: Date Created: 20210419 Date Completed: 20210705 Latest Revision: 20210705
رمز التحديث: 20221213
DOI: 10.1016/j.jbiomech.2021.110412
PMID: 33873110
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-2380
DOI:10.1016/j.jbiomech.2021.110412