Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems

Launched by AO INNOVATION TRANSLATION CENTER · Jun 4, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of a special type of surgical plate used to treat injuries to the clavicle (collarbone) and the acromioclavicular joint, which connects the collarbone to the shoulder. The researchers will study at least 76 patients who have had a clavicle fracture or dislocation and received surgery using either the Clavicle Plate or the Clavicle Hook Plate from the VA-LCP system. They aim to collect information about how well these plates work and any potential side effects for up to two years after the surgery.

To participate, patients need to be at least 18 years old and have a recent injury to one side of their clavicle that requires surgery within three weeks of the injury. They should also be able to attend follow-up visits after their surgery. However, patients with certain conditions, like stable fractures, infections, or severe health issues, will not be eligible. Those who join the study can expect regular check-ups to monitor their recovery and the performance of the surgical plates.

Gender

ALL

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