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

Description

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.

Conditions

Clavicle, Acromioclavicular Joint, Fracture

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Clavicle
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, United States, 27157

Cleveland

University Hospital, Cleveland, Ohio, United States, 11100

Cleveland

Metrohealth Medical Center, Cleveland, Ohio, United States, 44109

Columbia

Prisma Health Richland Hospital, Columbia, South Carolina, United States, 29203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AO Innovation Translation Center,

Simon Lambert, PRINCIPAL_INVESTIGATOR, University College London Hospital

Study Record Dates

2029-09-30