Medical Devices-Evidence and Research最新文献

{"title":"Nonclinical Bench Performance Testing of a Very Low-Cost Nonelectric Bubble Continuous Positive Airway Pressure (bCPAP) and Blenders Device Designed for Newborn Respiratory Support.","authors":"Patricia S Coffey, Alec Wollen","doi":"10.2147/MDER.S318218","DOIUrl":"10.2147/MDER.S318218","url":null,"abstract":"<p><strong>Purpose: </strong>Bubble continuous positive airway pressure (bCPAP) is often used to treat respiratory distress experienced by some 15 million preterm infants born globally every year. In low- and middle-income countries, improvised bCPAP devices are used, often without a blender that protects the infant from the sequelae of excessive oxygen exposure.</p><p><strong>Materials and methods: </strong>The aim of this bench testing was to assess the mechanical safety and performance of the PATH bCPAP and blenders device, which provides a stable and reliable source of pressurized blended gas without the requirement for a source of compressed medical air or electricity. The device includes two fixed ratio blenders: a \"low\" blend that provides 37% oxygen and a \"high\" blend that provides 60% oxygen. We performed bench testing to characterize the performance of the bCPAP and blenders, including respiratory circuit verification, blender verification, conditioned humidity testing, and sound measurement.</p><p><strong>Results: </strong>Test results for all performance variables met the acceptance criteria of our product requirement specification. The device provides a fixed ratio of air and oxygen that is consistent over the entire range of clinically relevant pressures (4 to 8 cmH₂O) and remains consistent despite changes in flow (2 to 7 liters per minute). The blend is stable within ± 5% of the blenders' nominal blend ratio when used with a 100% oxygen source, irrespective of the flow and pressure from the oxygen source or the flow and pressure of the blended gas delivered to the neonate. Sound and humidity test results were within specifications.</p><p><strong>Conclusion: </strong>This very low-cost nonelectric bCPAP and blenders device is optimally designed to deliver a stable and reliable source of pressurized blended gas.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"187-197"},"PeriodicalIF":1.3,"publicationDate":"2022-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/76/f2/mder-15-187.PMC9249094.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40468820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers.","authors":"Natalia A Wilson,&nbsp;James E Tcheng,&nbsp;Jove Graham,&nbsp;Joseph P Drozda","doi":"10.2147/MDER.S364539","DOIUrl":"https://doi.org/10.2147/MDER.S364539","url":null,"abstract":"<p><strong>Background: </strong>The requirement for medical device manufacturers to label their devices with a unique device identifier (UDI) was formalized by the 2013 US Food and Drug Administration Unique Device Identification System Rule. However, parallel regulatory requirement for US health systems to use UDIs, particularly the electronic documentation of UDIs during patient care is lacking. Despite the lack of regulation, some health systems have implemented and are using UDIs. To assess the current state, we studied representative health system UDI implementation experiences, including barriers and the strategies to overcome them, and identified next steps to advance UDI adoption.</p><p><strong>Methods: </strong>Semi-structured interviews were performed with health system personnel involved in UDI implementation in their cardiac catheterization labs or operating rooms. Interviews were transcribed and analyzed using the framework methodology of Ritchie and Spencer. An expert panel evaluated findings and informed barriers, strategies, and next steps.</p><p><strong>Results: </strong>Twenty-four interviews at ten health systems were performed. Identified barriers were internal (lack of organizational support, information technology gaps, clinical resistance) and external (information technology vendor resistance, limitations in manufacturer support, gaps in reference data, lack of an overall UDI system). Identified strategies included relationship building, education, engagement, and communication. Next steps to advance UDI adoption focus on education, research, support, and policy.</p><p><strong>Conclusions and implications: </strong>Delineation of UDI implementation barriers and strategies provides guidance and support for health systems to adopt the UDI standard and electronically document UDIs during clinical care. Next steps illuminate critical areas for attention to advance UDI adoption and achieve a comprehensive UDI system in health care to strengthen patient care and safety.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"177-186"},"PeriodicalIF":1.3,"publicationDate":"2022-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f8/14/mder-15-177.PMC9233486.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40406674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cervix Type and Cervical Cancer Classification System Using Deep Learning Techniques.","authors":"Lidiya Wubshet Habtemariam,&nbsp;Elbetel Taye Zewde,&nbsp;Gizeaddis Lamesgin Simegn","doi":"10.2147/MDER.S366303","DOIUrl":"https://doi.org/10.2147/MDER.S366303","url":null,"abstract":"<p><strong>Purpose: </strong>Cervical cancer is the 4th most common cancer among women, worldwide. Incidence and mortality rates are consistently increasing, especially in developing countries, due to the shortage of screening facilities, limited skilled professionals, and lack of awareness. Cervical cancer is screened using visual inspection after application of acetic acid (VIA), papanicolaou (Pap) test, human papillomavirus (HPV) test and histopathology test. Inter- and intra-observer variability may occur during the manual diagnosis procedure, resulting in misdiagnosis. The purpose of this study was to develop an integrated and robust system for automatic cervix type and cervical cancer classification using deep learning techniques.</p><p><strong>Methods: </strong>4005 colposcopy images and 915 histopathology images were collected from different local health facilities and online public datasets. Different pre-trained models were trained and compared for cervix type classification. Prior to classification, the region of interest (ROI) was extracted from cervix images by training and validating a lightweight MobileNetv2-YOLOv3 model to detect the transformation region. The extracted cervix images were then fed to the EffecientNetb0 model for cervix type classification. For cervical cancer classification, an EffecientNetB0 pre-trained model was trained and validated using histogram matched histopathological images.</p><p><strong>Results: </strong>Mean average precision (mAP) of 99.88% for the region of interest (ROI) extraction, and test accuracies of 96.84% and 94.5% were achieved for the cervix type and cervical cancer classification, respectively.</p><p><strong>Conclusion: </strong>The experimental results demonstrate that the proposed system can be used as a decision support tool in the diagnosis of cervical cancer, especially in low resources settings, where the expertise and the means are limited.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"163-176"},"PeriodicalIF":1.3,"publicationDate":"2022-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e3/52/mder-15-163.PMC9208738.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40224766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Efficacy of Inflatable Penile Prostheses for the Treatment of Erectile Dysfunction: Evidence to Date.","authors":"Vinson M Wang,&nbsp;Laurence A Levine","doi":"10.2147/MDER.S251364","DOIUrl":"https://doi.org/10.2147/MDER.S251364","url":null,"abstract":"<p><p>Erectile dysfunction (ED) is a common problem, and prevalence rates are expected to rise as life expectancy increases worldwide. In more severe cases of ED, penile prosthesis implantation has been an excellent option for patients. Over the past few decades, significant design improvements have been made to the penile prosthesis and modifications to surgical technique to improve clinical outcomes. The purpose of this review is to summarize the safety and efficacy of FDA-approved penile implants in the US market. Design modifications have greatly improved the safety and reliability of the implant. Development of improved surgical techniques has decreased intraoperative injuries and reservoir-related complications. With its high overall satisfaction rates and low risk of complications, the inflatable penile prosthesis remains an excellent option for patients with erectile dysfunction.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"27-36"},"PeriodicalIF":1.3,"publicationDate":"2022-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5f/12/mder-15-27.PMC8844936.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39933188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of an Articulating Laparoscopic Needle Holder (FlexDex™) Compared to a Conventional Rigid Needle Holder in 2-Dimension Vision Amongst Novices: A Randomised Controlled Study.","authors":"Nima Motahariasl,&nbsp;Sayed Borna Farzaneh,&nbsp;Sina Motahariasl,&nbsp;Ilya Kokotkin,&nbsp;Sara Sousi,&nbsp;Alexander Zargaran,&nbsp;David Zargaran,&nbsp;Bijendra Patel","doi":"10.2147/MDER.S345140","DOIUrl":"https://doi.org/10.2147/MDER.S345140","url":null,"abstract":"<p><strong>Aim: </strong>This study aims to compare novice performance of advanced bimanual laparoscopic skills using an articulating laparoscopic device (FlexDex™) compared to a standard rigid needle holder amongst surgical novices in 2-dimension (2D) visualisation.</p><p><strong>Methods: </strong>In this prospective randomised trial, novices (n = 40) without laparoscopic experience were recruited and randomised into two groups, which used either traditional rigid needle holders or the FlexDex™. Both groups performed 10 repetitions of a validated assessment task. Times taken and error rates were recorded, and results were evaluated based on completion times, error rates, and learning curves.</p><p><strong>Results: </strong>The intervention group that used the FlexDex™ completed 10 attempts of the standardised laparoscopic task slower than the control group that used traditional rigid needle holder (415 s versus 267 s taken for the first three attempts and 283 s versus 187 s taken for the last three attempts, respectively). The difference in average time for the first three and last three attempts reached statistical significance (P < 0.001). Furthermore, the intervention group demonstrated a higher error rate when compared to the control group (9.3 versus 6.2 errors per individual).</p><p><strong>Conclusion: </strong>When compared to the FlexDex™, the traditional rigid needle holder was observed to be superior in task performance speed, leading to shorter completion times and quicker learning effect, as well as fewer errors.</p><p><strong>Key statement: </strong>Traditional rigid needle holder leads to faster task completion times and lower error rates when compared with an articulating laparoscopic needle holder in 2D vision.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"15-25"},"PeriodicalIF":1.3,"publicationDate":"2022-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/57/bc/mder-15-15.PMC8824294.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39620375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Novel Measure of Acetabular Cup Inclination and Anteversion During Total Hip Arthroplasty.","authors":"William L Walter, Neri A Baker, Daniel Marsden-Jones, Ameneh Sadeghpour","doi":"10.2147/MDER.S339669","DOIUrl":"10.2147/MDER.S339669","url":null,"abstract":"<p><strong>Purpose: </strong>The purposes of the present research were to assess the accuracy and usability of the inertial navigation system (INS).</p><p><strong>Materials and methods: </strong>The accuracy of the device navigation subsystem was assessed using benchtop testing. The usability was assessed through simulated use with surgeons. These results were compared to recent cadaveric results for the same system.</p><p><strong>Results: </strong>The navigation subsystem had an overall mean absolute error of 1.21° and a maximum absolute error across all devices of 4.79°. The device was found to be usable and to add an estimated 7 minutes to surgery time.</p><p><strong>Conclusion: </strong>The INS uses a novel approach to provide the surgeon with accurate and fast acetabular cup inclination and anteversion angles during THA.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"1-14"},"PeriodicalIF":1.3,"publicationDate":"2022-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f7/4d/mder-15-1.PMC8806051.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39583341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Advanced Bimanual Skills in Novices Using the Wrist-Like FlexDex™ Articulating Laparoscopic Needle Holder in 2D and 3D Vision: A Randomised Trial.","authors":"Nima Motahariasl,&nbsp;Sayed Borna Farzaneh,&nbsp;Sina Motahariasl,&nbsp;Ilya Kokotkin,&nbsp;Sara Sousi,&nbsp;Alexander Zargaran,&nbsp;David Zargaran,&nbsp;Bijendra Patel","doi":"10.2147/MDER.S344975","DOIUrl":"https://doi.org/10.2147/MDER.S344975","url":null,"abstract":"<p><strong>Aim: </strong>The aim of this study was to evaluate the novice performance of advanced bimanual laparoscopic skills using the articulating FlexDex^TM laparoscopic needle holder in two-dimensional (2D) and three-dimensional (3D) visual systems.</p><p><strong>Methods: </strong>In this prospective randomised trial, novices (n=40) without laparoscopic experience were recruited from a university cohort and randomised into two groups, which used the FlexDex^TM and 2D or the FlexDex™ and 3D. Both groups performed 10 repetitions of a validated assessment task. Times taken and error rates were measured, and assessments were made based on completion times, error rates and learning curves.</p><p><strong>Results: </strong>The intervention group that used FlexDex^TM and 3D visual output completed 10 attempts of the standardised laparoscopic task quicker than the control group that used FlexDex^TM with standard 2D visual output (268 seconds vs 415 seconds taken for the first three attempts and 176 seconds vs 283 seconds taken for the last three attempts, respectively). Moreover, each attempt was completed faster by the intervention group compared to the control group. The difference in average time for the first three and last three attempts reached statistical significance (P < 0.001).</p><p><strong>Conclusion: </strong>Combination of 3D visual systems and the FlexDex^TM laparoscopic needle holder resulted in superior task performance speed, leading to shorter completion times and quicker learning effect. Although the 3D group demonstrated lower mean error rates, it did not reach statistical significance.</p><p><strong>Key statement: </strong>3D visual systems lead to faster task completion times when combined with an articulating laparoscopic needle holder compared to 2D vision. This effect however is not seen in error rates.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"14 ","pages":"469-480"},"PeriodicalIF":1.3,"publicationDate":"2021-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ca/fc/mder-14-469.PMC8722694.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39800005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Medical Device Unique Device Identifier as the Single Source of Truth in Healthcare Enterprises - Roadmap for Implementation of the Clinically Integrated Supply Chain.","authors":"James E Tcheng,&nbsp;Miriam V Nguyen,&nbsp;Helen W Brann,&nbsp;Patricia A Clarke,&nbsp;Maureen Pfeiffer,&nbsp;Jane R Pleasants,&nbsp;Gregory W Shelton,&nbsp;Joseph F Kelly","doi":"10.2147/MDER.S344132","DOIUrl":"https://doi.org/10.2147/MDER.S344132","url":null,"abstract":"<p><p>Documentation and tracking of supplies, equipment and medical devices is central to operational, financial, and clinical aspects of safe, efficient, and effective patient care. The labeling of medical devices with a unique device identifier (UDI) creates the opportunity to tightly integrate device information across health information systems by using the UDI as the index \"source of truth\". Across 3 hospitals of the Duke University Health System, we executed a comprehensive implementation of UDI-based device and supply information management in our cardiac catheterization and electrophysiology laboratories. Following are our key insights. Implementing a UDI-centric environment is a complex undertaking requiring integration of information systems, management processes, and clinical workflows involving leadership, inventory management, supply chain, clinical and billing teams. Implementation involves the domains of procedure documentation, electronic health records (EHRs), charge capture and billing, and interface and information technology systems, including information systems vendors. Replacing manual processes with electronic messages is not simply an exercise in programming information systems - successful execution requires orchestrated re-engineering of clinical and operational workflows. Our initiative resulted in a more efficient and effective supply chain, eliminated operational and clinical documentation errors, automated the posting of device implant data to the EHR, reduced clinician burden, improved charge capture, and produced a substantial financial benefit, with return on investment recognized in well under 1 year. We believe our stepwise approach to accomplishing a clinically integrated supply chain can serve as a roadmap for other healthcare enterprises to follow.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"14 ","pages":"459-467"},"PeriodicalIF":1.3,"publicationDate":"2021-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/35/4e/mder-14-459.PMC8714004.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39668381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mobile Cardiac Outpatient Telemetry Patch vs Implantable Loop Recorder in Cryptogenic Stroke Patients in the US - Cost-Minimization Model.","authors":"Goran Medic,&nbsp;Nikos Kotsopoulos,&nbsp;Mark P Connolly,&nbsp;Jennifer Lavelle,&nbsp;Vincent Norlock,&nbsp;Manish Wadhwa,&nbsp;Belinda A Mohr,&nbsp;Wayne M Derkac","doi":"10.2147/MDER.S337142","DOIUrl":"https://doi.org/10.2147/MDER.S337142","url":null,"abstract":"<p><strong>Purpose: </strong>The aim of this study was to compare costs and outcomes of mobile cardiac outpatient telemetry (MCOT) patch followed by implantable loop recorder (ILR) compared to ILR alone in cryptogenic stroke patients from the US health-care payors' perspective.</p><p><strong>Patients and methods: </strong>A quantitative decision tree cost-minimization simulation model was developed. Eligible patients were 18 years of age or older and were diagnosed with having a cryptogenic stroke, without previously documented atrial fibrillation (AF). All patients were assigned first to one then to the alternative monitoring strategies. Following AF detection, patients were initiated on oral anticoagulants (OAC). The model assessed direct costs for one year attributed to MCOT patch followed by ILR or ILR alone using a monitoring duration of 30 days post-cryptogenic stroke.</p><p><strong>Results: </strong>In the base case modeling, the MCOT patch arm detected 4.6 more patients with AFs compared to the ILR alone arm in a cohort of 1000 patients (209 vs 45 patients with detected AFs, respectively). Using MCOT patch followed by ILR in half of the patients initially undiagnosed with AF leads to significant cost savings of US$4,083,214 compared to ILR alone in a cohort of 1000 patients. Cost per patient with detected AF was significantly lower in the MCOT patch arm $29,598 vs $228,507 in the ILR only arm.</p><p><strong>Conclusion: </strong>An initial strategy of 30-day electrocardiogram (ECG) monitoring with MCOT patch in diagnosis of AF in cryptogenic stroke patients realizes significant cost-savings compared to proceeding directly to ILR only. Almost 8 times lower costs were achieved with improved detection rates and reduction of secondary stroke risk due to new anticoagulant use in subjects with MCOT patch detected AF. These results strengthen emerging recommendations for prolonged ECG monitoring in secondary stroke prevention.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"14 ","pages":"445-458"},"PeriodicalIF":1.3,"publicationDate":"2021-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/69/94/mder-14-445.PMC8694406.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39763758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Cadaver-Based Biomechanical Evaluation of a Novel Posterior Approach to Sacroiliac Joint Fusion: Analysis of the Fixation and Center of the Instantaneous Axis of Rotation.","authors":"Dawood Sayed,&nbsp;Kasra Amirdelfan,&nbsp;Ramana K Naidu,&nbsp;Oluwatodimu R Raji,&nbsp;Steven Falowski","doi":"10.2147/MDER.S347763","DOIUrl":"https://doi.org/10.2147/MDER.S347763","url":null,"abstract":"<p><strong>Purpose: </strong>The purpose of this study was to assess the stabilizing effect of a posterior joint fixation technique using a novel cortical allograft implant in unilateral and bilateral fixation constructs. We hypothesize that fixation would reduce the joint's range of motion during flexion-extension, axial rotation, and lateral bending loads. We also hypothesize that fixation would shift the center of the instantaneous axis of rotation during the predominant flexion-extension motions towards the implant's location, and that this shift would be correlated with the reduction in flexion-extension range of motion.</p><p><strong>Materials and methods: </strong>Six cadaveric sacroiliac joint specimens were tested under intact, unilateral fixation, and bilateral fixation conditions. The total range of motion (ROM) of the sacroiliac joint in flexion-extension, lateral bending, and axial rotation were evaluated by an optical tracking system, in a multidirectional flexibility pure moment model, between ± 7.5 Nm applied moment loads. The centers of the instantaneous axis of rotation (cIAR) of the sacroiliac joint were evaluated during flexion-extension loading. A correlation analysis was performed between the ROM reduction in flexion-extension upon implantation and shift of the cIAR to the graft implantation site.</p><p><strong>Results: </strong>Unilateral and bilateral fixations generated sacroiliac joint ROM reductions in flexion-extension, lateral bending, and axial rotation motions. Fixation shifted the cIAR to the graft implantation site. Reduction in the total range of motion had a moderate correlation with the shift of the cIAR.</p><p><strong>Conclusion: </strong>Our novel posterior approach presents a multifaceted mechanism for stabilizing the joint: first, by the reduction of the total range of motion in all planes of motion; second, by shifting the centers of the instantaneous axis of rotation towards the implant's location in the predominant plane of motion, ensuring little to no motion at the implantation site, thus promoting fusion in this region.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"14 ","pages":"435-444"},"PeriodicalIF":1.3,"publicationDate":"2021-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/20/af/mder-14-435.PMC8691588.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39760165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}