RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07-10
Study Completion:2029-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04921865

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 18 years
  2. * 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:
  3. * VA-LCP® Clavicle Plates 2.7: Fixation of clavicle bone fragments
  4. * VA-LCP® Clavicle Hook Plates 2.7: Fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint
  5. * VA-LCP Clavicle Button Hook Plates 2.7: Fixation of acromioclavicular joint dislocations
  6. * Expected ability to attend postoperative FU visits
  7. * Patient informed and consent obtained according to the IRB/EC defined and approved procedures
  1. * Stable clavicle fractures
  2. * Systemic infection or infection localized to the site of the proposed implantation
  3. * Concomitant nerve or vessel injury
  4. * Polytrauma (Injury Severity Score ≥ 16)
  5. * BMI ≥40
  6. * Uncontrolled severe systemic disease or terminal illness
  7. * Intraoperative decision to use other implant

Contacts and Locations

Study Contact

Alix Frischknecht
CONTACT
+41 79 606 41 48
alix.frischknecht@aofoundation.org
Maria Clara Medina Giner
CONTACT
+41 79 545 61 20
maria.medinaginer@aofoundation.org

Principal Investigator

Simon Lambert
PRINCIPAL_INVESTIGATOR
University College London Hospital

Study Locations (Sites)

Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
University Hospital
Cleveland, Ohio, 11100
United States
Metrohealth Medical Center
Cleveland, Ohio, 44109
United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
United States

Collaborators and Investigators

Sponsor: AO Innovation Translation Center

  • Simon Lambert, PRINCIPAL_INVESTIGATOR, University College London Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-10
Study Completion Date2029-09-30

Study Record Updates

Study Start Date2024-07-10
Study Completion Date2029-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Clavicle
  • Acromioclavicular Joint
  • Fracture