NCT04921865 Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems
| NCT ID | NCT04921865 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AO Innovation Translation Center |
| Condition | Clavicle |
| Study Type | OBSERVATIONAL |
| Enrollment | 76 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 76 participants in total. It began in 2024-07-10 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Simon Lambert
PRINCIPAL INVESTIGATOR
University College London Hospitals
Frequently Asked Questions
Who can join the NCT04921865 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Clavicle. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04921865 currently recruiting?
Yes, NCT04921865 is actively recruiting participants. Contact the research team at marco.minoia@aofoundation.org for enrollment information.
Where is the NCT04921865 trial being conducted?
This trial is being conducted at Grand Rapids, United States, Winston-Salem, United States, Columbia, United States, Vienna, Austria and 3 additional locations.
Who is sponsoring the NCT04921865 clinical trial?
NCT04921865 is sponsored by AO Innovation Translation Center. The principal investigator is Simon Lambert at University College London Hospitals. The trial plans to enroll 76 participants.