Actively Recruiting
Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems
Led by AO Innovation Translation Center · Updated on 2025-08-29
76
Participants Needed
7
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Unilateral clavicle injury with primary surgical treatment within 21 days from injury using DPS VA-LCP Clavicle Plate
- Use of VA-LCP Clavicle Plates 2.7 for fixation of clavicle bone fragments
- Use of VA-LCP Clavicle Hook Plates 2.7 for fixation of lateral clavicle fractures and acromioclavicular joint dislocations
- Use of VA-LCP Clavicle Button Hook Plates 2.7 for fixation of acromioclavicular joint dislocations
- Expected ability to attend postoperative follow-up visits
- Patient informed consent obtained according to IRB/EC procedures
You will not qualify if you...
- Stable clavicle fractures
- Systemic infection or infection localized at the implantation site
- Concomitant nerve or vessel injury
- Polytrauma with Injury Severity Score 16 or higher
- Body mass index of 40 or higher
- Uncontrolled severe systemic disease or terminal illness
- Intraoperative decision to use other implant
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
2
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
3
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
4
Klinik Ottakring
Vienna, Austria, 1160
Actively Recruiting
5
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
6
Universitätsklinikum Münster
Münster, Germany, 48149
Actively Recruiting
7
Luzerner Kantonsspital
Lucerne, Switzerland, 6000
Actively Recruiting
Research Team
M
Marco Minoia, PhD
CONTACT
M
Maria Clara Medina Giner
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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