Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAO Innovation Translation Center
About this trial
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
Qualifiers
Age >= 18 years
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System
Treatment groups
76 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov