{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T16:34:36Z","timestamp":1753893276142,"version":"3.41.2"},"reference-count":20,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,3,27]],"date-time":"2025-03-27T00:00:00Z","timestamp":1743033600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Surg."],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Degenerative diseases of the spine are increasingly prevalent with age. Spinal fusion is a common treatment if non-invasive or less-invasive treatment approaches have not been successful. Numerous clinical trials on spinal fusion are started every year to investigate novel technologies worldwide. However, a substiantial amount of trials are terminated prior to completion.<\/jats:p><\/jats:sec><jats:sec><jats:title>Research question<\/jats:title><jats:p>In this study, we analyzed the historical performance of all clinical trials on spinal fusion since 2010.<\/jats:p><\/jats:sec><jats:sec><jats:title>Material and methods<\/jats:title><jats:p>The identification of related trials was carried out using Protocol AI, which is the Risklick's software. It collects and updates clinical trial data from various sources, including clinical trial registries and datasets from the World Health Organization. Protocol AI has automatically extracted the data on trial, categorized them, and clustered them in trial phases.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The historical probability of early termination for a clinical trial investigating spinal fusion was approximately 25%. The average trial delay for completed trials was 10.6 months. With an average anticipated trial duration approaching 40 months, the observed delay represents an extension of 25% of the anticipated trial duration for completed trials. Trials facing delay and failure predominantly reported critical issues with patient recruitment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Dicsussion and conclusion<\/jats:title><jats:p>This study emphasizes the importance of implementing a strict risk management plan and recruitment plans, while suggesting professionals to implement standardized enrollment monitoring analyzes during the course of the trial. The amelioration of recruitment policies could substantially maximize the performance of trials within the field, benefiting patients and all stakeholders involved.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fsurg.2025.1546367","type":"journal-article","created":{"date-parts":[[2025,3,28]],"date-time":"2025-03-28T01:48:32Z","timestamp":1743126512000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Work smart, not hard: analysis of delays faced by clinical trials investigating spinal fusion using Protocol AI"],"prefix":"10.3389","volume":"12","author":[{"given":"Katia","family":"Schiegg","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philipp","family":"Khlebnikov","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Florian","family":"Meer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joel","family":"K\u00fchl","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Poorya","family":"Amini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Janine","family":"Antonov","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emin","family":"Aghayev","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephan","family":"Radzanowski","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Quentin","family":"Haas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2025,3,27]]},"reference":[{"volume-title":"Essential Orthopaedics","year":"2010","author":"Miller","key":"B1"},{"key":"B2","doi-asserted-by":"publisher","first-page":"5389","DOI":"10.1038\/s41598-021-84724-6","article-title":"Prevalence of spine degeneration diagnosis by type, age, gender, and obesity using medicare data","volume":"11","author":"Parenteau","year":"2021","journal-title":"Sci Rep"},{"key":"B3","doi-asserted-by":"publisher","first-page":"752","DOI":"10.21037\/jss-20-492","article-title":"Trends in lumbar spinal fusion-a literature review","volume":"6","author":"Reisener","year":"2020","journal-title":"J Spine Surg"},{"key":"B4","doi-asserted-by":"publisher","first-page":"1535","DOI":"10.1016\/j.spinee.2020.06.008","article-title":"Why are patients dissatisfied after spine surgery when improvements in disability and pain are clinically meaningful?","volume":"20","author":"Sivaganesan","year":"2020","journal-title":"Spine J"},{"key":"B5","doi-asserted-by":"publisher","first-page":"63","DOI":"10.3390\/surgeries1020008","article-title":"Patient-reported expectations, outcome and satisfaction in thoracic and lumbar spine stabilization surgery: a prospective study","volume":"1","author":"Krauss","year":"2020","journal-title":"Surgeries"},{"key":"B6","doi-asserted-by":"publisher","first-page":"156","DOI":"10.1016\/j.conctc.2018.08.001","article-title":"Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review","volume":"11","author":"Fogel","year":"2018","journal-title":"Contemp Clin Trials Commun"},{"key":"B7","doi-asserted-by":"publisher","first-page":"42","DOI":"10.33393\/ao.2022.2437","article-title":"New trends in clinical trials\u2014between complexity and the need for renewal","volume":"9","author":"Cagnazzo","year":"2022","journal-title":"AboutOpen"},{"key":"B8","doi-asserted-by":"publisher","first-page":"307","DOI":"10.1038\/nrd.2017.65","article-title":"Trial watch: trends in clinical trial design complexity","volume":"16","author":"Getz","year":"2017","journal-title":"Nat Rev Drug Discov"},{"key":"B9","doi-asserted-by":"publisher","first-page":"244","DOI":"10.1159\/000515908","article-title":"Utilizing artificial intelligence to manage COVID-19 scientific evidence torrent with Risklick AI: a critical tool for pharmacology and therapy development","volume":"106","author":"Haas","year":"2021","journal-title":"Pharmacology"},{"key":"B10","doi-asserted-by":"publisher","first-page":"745674","DOI":"10.3389\/fdgth.2021.745674","article-title":"Vaccine development in the time of COVID-19: the relevance of the Risklick AI to assist in risk assessment and optimize performance","volume":"3","author":"Haas","year":"2021","journal-title":"Front Digit Health"},{"key":"B11","doi-asserted-by":"publisher","first-page":"357","DOI":"10.1145\/582415.582416","article-title":"Probabilistic models of information retrieval based on measuring the divergence from randomness","volume":"20","author":"Amati","year":"2002","journal-title":"ACM Trans. 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