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RecruitingClavicleAcromioclavicular JointFracture

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

Eligible age

18+ yrs

Accepts

All genders

Locations

3 states

Healthy volunteers

No

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About this study

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.

Sponsor: AO Innovation Translation Center

You may qualify if…

  • 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

You may not qualify if…

  • 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 it's recruiting

Michigan

Grand Rapids

North Carolina

Winston-Salem

Source: ClinicalTrials.gov · NCT04921865 · last updated 2025-08-29