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Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems

Recruitingn/aAges 18 Years - anyAllAO Innovation Translation Center
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to gather early and mid- to long-term evidence to confirm the clinical performance, safety and use of the Clavicle Plate and Clavicle Hook Plate System. A minimum of 76 patients with clavicle fractures or dislocations of the AC joint surgically treated with any plate from the DPS VA-LCP Clavicle System will be enrolled in this observational post-market clinical investigation. Outcomes will be collected until up to 2 years after surgery.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Age \>= 18 years * Unilateral clavicel injury and primary surgical treatment within 21 days from injury with a DPS VA-LCP® Clavicle Plate according to manufacturer's instruction use: * VA-LCP® Clavicle Plates 2.7: Fixation of clavicle bone fragments * VA-LCP® Clavicle Hook Plates 2.7: Fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint * VA-LCP Clavicle Button Hook Plates 2.7: Fixation of acromioclavicular joint dislocations * Expected ability to attend postoperative FU visits * Patient informed and consent obtained according to the IRB/EC defined and approved procedures Exclusion Criteria: * Stable clavicle fractures * Systemic infection or infection localized to the site of the proposed implantation * Concomitant nerve or vessel injury * Polytrauma (Injury Severity Score ≥ 16) * BMI ≥40 * Uncontrolled severe systemic disease or terminal illness * Intraoperative decision to use other implant
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What it tests

  • DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System
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Where

7 sites
Corewell Health
Grand Rapids, United States
Atrium Health Wake Forest Baptist
Winston-Salem, United States
Prisma Health Richland Hospital
Columbia, United States
Klinik Ottakring
Vienna, Austria
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Universitätsklinikum Münster
Münster, Germany
Luzerner Kantonsspital
Lucerne, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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