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

Last updated: April 8, 2025
Sponsor: AO Innovation Translation Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bone Fractures

Treatment

DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System

Clinical Study ID

NCT04921865
VA Clavicle
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Age >= 18 years

  • Unilateral clavicel injury and primary surgical treatment within 21 days from injurywith 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 anddislocations of the acromioclavicular joint

  • VA-LCP Clavicle Button Hook Plates 2.7: Fixation of acromioclavicular jointdislocations

  • Expected ability to attend postoperative FU visits

  • Patient informed and consent obtained according to the IRB/EC defined and approvedprocedures

Exclusion

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

Study Design

Total Participants: 76
Treatment Group(s): 1
Primary Treatment: DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System
Phase:
Study Start date:
July 10, 2024
Estimated Completion Date:
September 30, 2029

Study Description

Common problems with existing clavicular plates are poor plate 'fit,' unbalance fixation, plate prominence, associated soft tissue irritation, subacromial pain, plate and/or fixation failure (due to unbalanced fixation) and high reoperation rate (for plate removal) [1-3]. The newly developed DePuy Synthes (DPS) variable angle locking compression plate (VA-LCP®) Clavicle 2.7 System was designed to address these problems. The system consists of lateral, shaft and medial plates and hook plates of different sizes to cover a wide variation in clavicular morphology and diverse fracture, fracture-dislocation and dislocation indications.

The objective is to describe the short and long-term clinical performance and safety of both systems, as well as the functional outcomes of this patient population.

Outcomes will be collected at baseline, 2 weeks, 6 weeks, 3 months, 6 months 1, and 2 years after surgery. In addition, the surgeons' experience and utility of the devices will be surveyed. For the short term evaluation, an interim analysis will be done as soon as 30 patients in each group have completed 6 months of follow-up (FU). The final evaluation of long-term outcomes will be done after 2 years of FU.

All treatments and follow-up visits are according to standard of care.

Connect with a study center

  • Klinik Ottakring

    Wien, 1160
    Austria

    Active - Recruiting

  • Universitätsklinikum Freiburg

    Freiburg, 79106
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Active - Recruiting

  • Luzerner Kantonsspital

    Luzern, 6000
    Switzerland

    Active - Recruiting

  • University College London Hospital

    London, NW1 2BU
    United Kingdom

    Site Not Available

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Metrohealth Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • University Hospital

    Cleveland, Ohio 11100
    United States

    Suspended

  • Prisma Health Richland Hospital

    Columbia, South Carolina 29203
    United States

    Active - Recruiting

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