Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems
Trial Parameters
Brief Summary
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.
Eligibility Criteria
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