Evaluating the performance of new clavicle plates for fractures and dislocations

Observational Case Series on the Clinical Performance of the DePuy Synthes Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 Systems

This study is testing a new type of plate for fixing broken collarbones to see how well it works and how safe it is for patients over two years after surgery.

Quick facts

• Study type: Observational
• Enrollment: 76 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AO Innovation Translation Center (Academic / other)
• Locations: 7 sites (Grand Rapids, Michigan and 6 other locations)
• Trial ID: NCT04921865 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather evidence on the clinical performance and safety of the DePuy Synthes variable angle locking compression plate (VA-LCP) Clavicle 2.7 System. A minimum of 76 patients with clavicle fractures or acromioclavicular joint dislocations will be enrolled and followed for up to two years post-surgery. Outcomes will be assessed at multiple time points, including baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgery. The study will also evaluate the surgeons' experiences with the devices used.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unilateral clavicle injuries requiring surgical treatment within 21 days of injury.

Not a fit: Patients with stable clavicle fractures or those with severe systemic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients with clavicle fractures and dislocations.

How similar studies have performed: While this approach is based on existing technologies, the specific performance of the VA-LCP Clavicle 2.7 System has not been extensively tested in prior studies.

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

Where this trial is running

Grand Rapids, Michigan and 6 other locations

• Corewell Health — Grand Rapids, Michigan, United States (Recruiting)
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)
• Prisma Health Richland Hospital — Columbia, South Carolina, United States (Recruiting)
• Klinik Ottakring — Vienna, Austria (Recruiting)
• Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany (Recruiting)
• Universitätsklinikum Münster — Münster, Germany (Recruiting)
• Luzerner Kantonsspital — Lucerne, Switzerland (Recruiting)

Study contacts

• Principal investigator: Simon Lambert — University College London Hospitals
• Study coordinator: Marco Minoia, PhD

Conditions Clavicle; Acromioclavicular Joint; Fracture