Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems
Recruiting now
Conditions studied: Clavicle, Acromioclavicular Joint, Fracture
In brief
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.
Key facts
- Study ID
- NCT04921865
- Run by
- AO Innovation Translation Center
- People needed
- 76
- Starts
- 2024-07-10
- Expected to finish
- 2029-09-30
- Last updated by the study team
- 2025-08-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Corewell Health — Grand Rapids, Michigan, United States (enrolling)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (enrolling)
- Prisma Health Richland Hospital — Columbia, South Carolina, United States (enrolling)
- Klinik Ottakring — Vienna, Austria (enrolling)
- Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany (enrolling)
- Universitätsklinikum Münster — Münster, Germany (enrolling)
- Luzerner Kantonsspital — Lucerne, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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