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Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems
Observational Case Series on the Clinical Performance of the DePuy Synthes Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 Systems
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System (device)
Sponsor: AO Innovation Translation Center · Participants: 76 · Started: Jul 10, 2024
Contact the study team
- Marco Minoia, PhD · Phone: +41 79 612 09 67
- Maria Clara Medina Giner · Phone: +41 79 545 61 20
Official record on ClinicalTrials.gov — NCT04921865
Locations in the U.S.
| Michigan | Corewell Health, Grand Rapids |
| North Carolina | Atrium Health Wake Forest Baptist, Winston-Salem |
| South Carolina | Prisma Health Richland Hospital, Columbia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.