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
AO Innovation Translation Center
76 participants
Jul 10, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria7
- 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
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Interventions
The DPS VA-LCP® Clavicle Plate 2.7 System is indicated for the fixation of clavicle bone fragments. The system consists of three plate types: lateral, shaft, and medial, each available in different sizes and materials (titanium alloy and stainless steel). Each plate is available in left and right. The DPS VA-LCP® Clavicle Clavicle Hook Plate 2.7 System is indicated or the fixation of lateral clavicle fractures and AC joint dislocations. The Clavicle Hook Plate system consists of three plate types: long, short and button plates.
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT04921865