Observational case series on the clinical performance of the Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 systems: a study protocol

Martin Jaeger^1,2*Julia Sußiek³Frank Beeres^4,5Eben Carroll⁶Todd Conlan⁷Daniel Cunningham⁸Richard Arnhold⁹Simon Lambert¹⁰

• ¹University of Freiburg Medical Center, Freiburg, Germany
• ²Albert-Ludwigs-Universität Orthopädie and Traumatologie, Freiburg im Breisgau, Germany
• ³Department of Trauma-, Hand- and Reconstructive Surgery, University Hospital Muenster, Muenster, Germany
• ⁴Department of Orthopedic and Trauma Surgery, Lucerne Cantonal Hospital, Lucerne, Switzerland
• ⁵Faculty of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland
• ⁶Atrium Health Wake Forest Baptist Orthopaedic Surgery, Winston-Salem, United States
• ⁷Corewell Health, Department of Orthopedic Surgery, Grand Rapids, United States
• ⁸Prisma Health Richland Hospital, Orthopaedic Trauma Surgery, Columbia, United States
• ⁹Klinik Ottakring, Vienna, Austria
• ¹⁰The Princess Grace Hospital, HCA Healthcare UK, London, United Kingdom

Background 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 2.7mm variable angle locking compression plate (VA-LCP®) Clavicle Plate and 2.7mm VA-LCP® Clavicle Hook Plate (J&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 2.7mm screws. Primary objectives of this observational, post-marketing, prospective, multicenter case series are to gather early and mid-to long-term evidence on clinical performance, safety, and usability of the 2.7mm VA-LCP Clavicle Plates and 2.7mm VA-LCP Clavicle Hook Plates, specifically to describe safety, clinical performance, functional outcomes, patient-reported outcomes (PROs), and usability and surgeons' experience with the devices. Methods Approximately 76 patients with clavicle fractures and primary surgical treatment with the 2.7mm VA-LCP Clavicle Plate or 2.7mm 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® 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. Discussion 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 2.7mm VA-LCP Clavicle Plates and 2.7mm 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. Registered at Clinicaltrials.gov NCT04921865 on 28/5/2021.