{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T05:23:44Z","timestamp":1780550624974,"version":"3.54.1"},"reference-count":30,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T00:00:00Z","timestamp":1767830400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001702","name":"AO Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001702","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Surg."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Reoperation rates in clavicular fractures and acromioclavicular (AC) joint dislocations are high, often indicated for plate removal due to plate prominence and poor cosmesis. The recently designed 2.7\u2005mm variable angle locking compression plate (VA-LCP\u00ae) Clavicle Plate and 2.7\u2005mm VA-LCP\u00ae Clavicle Hook Plate (J&amp;amp;J MedTech) are intended to have an improved plate-to-bone fit, are precontoured, and have a low profile. Additionally, the Clavicle Hook Plate has a more anatomically adapted hook design to reduce the risk of painful osteolysis leading to earlier plate removals. All screw holes in these plates accept 2.7\u2005mm screws. Primary objectives of this observational, post-marketing, prospective, multicenter case series are to gather early and mid- to long-term evidence on the clinical performance, safety, and usability of the 2.7\u2005mm VA-LCP Clavicle Plates and 2.7\u2005mm VA-LCP Clavicle Hook Plates, specifically to describe (1) safety, (2) clinical performance, (3) functional outcomes, (4) patient-reported outcomes (PROs) and (5) usability and surgeons' experience with the devices.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Approximately 76 patients with clavicle fractures and primary surgical treatment with the 2.7\u2005mm VA-LCP Clavicle Plate or 2.7\u2005mm VA-LCP Clavicle Hook Plate will be enrolled prospectively over 15 months. Outcome measures include adverse events related\/potentially related to the investigational device, clinical performance, functional outcomes (QuickDASH), PROs (PROMIS\u00ae upper extremity score, local pain, discomfort, and plate prominence), and radiographic outcomes. Data will be collected at baseline, 2w, 6w, 3m, 6m, 1y and 2y after surgery. The surgeons' experience with and perceived utility of the devices will be surveyed. Interim analysis will be performed when 30 patients per group have reached 6 months after surgery. Long-term outcomes will be evaluated using 2-year follow-up results. A Statistical Analysis Plan will be prepared before final analysis summarizing the descriptive statistics to be used.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The study described in this protocol on patients with clavicular fracture or AC joint dislocations undergoing surgical fracture fixation aims to gather first evidence on the clinical performance, safety, and usability of the 2.7\u2005mm VA-LCP Clavicle Plates and 2.7\u2005mm VA-LCP Clavicle Hook Plate Systems. This study will provide valuable data from a standard-of-care setting and may help design future comparative studies for relevant performance parameters.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link>https:\/\/clinicaltrials.gov\/study\/NCT04921865?term=NCT04921865%20&amp;amp;rank=1<\/jats:ext-link>\n                      , identifier NCT04921865.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fsurg.2025.1694295","type":"journal-article","created":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T06:37:44Z","timestamp":1767854264000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Observational case series on the clinical performance of the Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 systems: a study protocol"],"prefix":"10.3389","volume":"12","author":[{"given":"Martin","family":"Jaeger","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Su\u00dfiek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Beeres","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eben","family":"Carroll","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd","family":"Conlan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Cunningham","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Arnhold","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Lambert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,1,8]]},"reference":[{"key":"B1","first-page":"573","article-title":"Clavicle","volume-title":"AO principles of Fracture Management","author":"Kwek","year":"2017"},{"key":"B2","doi-asserted-by":"publisher","first-page":"Cd009363","DOI":"10.1002\/14651858.CD009363.pub3","article-title":"Surgical versus conservative interventions for treating fractures of the middle third of the clavicle","volume":"1","author":"Lenza","year":"2019","journal-title":"Cochrane Database Syst Rev"},{"key":"B3","doi-asserted-by":"publisher","first-page":"519","DOI":"10.26603\/001c.32545","article-title":"Nonoperative management of traumatic acromioclavicular joint injury: a clinical commentary with clinical practice considerations","volume":"17","author":"Sciascia","year":"2022","journal-title":"Int J Sports Phys Ther"},{"key":"B4","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1186\/s10195-018-0492-0","article-title":"Are clinical outcomes affected by type of plate used for management of mid-shaft clavicle fractures?","volume":"19","author":"Alzahrani","year":"2018","journal-title":"J Orthop Traumatol"},{"key":"B5","doi-asserted-by":"publisher","first-page":"901","DOI":"10.1080\/13696998.2019.1620245","article-title":"Surgical treatment, complications, and reimbursement among patients with clavicle fracture and acromioclavicular dislocations: a US retrospective claims database analysis","volume":"22","author":"Putnam","year":"2019","journal-title":"J Med Econ"},{"key":"B6","doi-asserted-by":"publisher","first-page":"392","DOI":"10.1097\/CORR.0000000000000986","article-title":"What is the best evidence for management of displaced midshaft clavicle fractures? 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