RecruitingNot Applicable

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

United States, Austria, Germany76 participantsStarted 2024-07-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety aspects

Timeframe: Patients treated with clavicle plate: From baseline up to 24 months after surgery; Patients treated with clavicle hook plate: From baseline until device removal (approximately 3months) and up to 12 months after device removal

Clinical performance

Timeframe: Through study completion, an average of 1 year

Utility in terms of surgeons' experience

Timeframe: Assessed immediately after the surgery

Surgical time

Timeframe: Assessed immediately after surgeries

Fluoroscopy time

Timeframe: Assessed immediately after surgeries

The Disabilities of the Arm Shoulder and Hand short form (QuickDASH)

Trial details

NCT IDNCT04921865

SponsorAO Innovation Translation Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-01-31

Contact for this trial

Marco Minoia, PhD

+41 79 612 09 67 marco.minoia@aofoundation.org

View on ClinicalTrials.gov More Clavicle trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety aspects

Clinical performance

Timeframe: Through study completion, an average of 1 year

Utility in terms of surgeons' experience

Timeframe: Assessed immediately after the surgery

Surgical time

Timeframe: Assessed immediately after surgeries

Fluoroscopy time

Timeframe: Assessed immediately after surgeries

The Disabilities of the Arm Shoulder and Hand short form (QuickDASH)