Observational case series on the clinical performance of the Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 systems: a study protocol.
Martin Jaeger, Julia Sußiek, Frank Beeres...
https://pubmed.ncbi.nlm.nih.gov/41583835Actively Recruiting
Age: 18Years +
All Genders
ID04921865
Observational Case Series on the Clinical Performance of the DePuy Synthes Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 Systems
Led by AO Innovation Translation Center · Updated on 2025-08-29
76
Participants Needed
7
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect early and long-term data on the clinical performance, safety, and use of the DePuy Synthes (DPS) variable angle locking compression plate (VA-LCP) Clavicle 2.7 System and the Clavicle Hook Plate 2.7 System. The study focuses on patients with clavicle fractures or acromioclavicular (AC) joint dislocations who undergo surgical treatment with these devices. The goal is to better understand outcomes and address issues seen with existing clavicle plates, such as poor fit and soft tissue irritation. The study involves patients treated surgically with any plate from the DPS VA-LCP Clavicle System, including lateral, shaft, medial, and hook plates in various sizes and materials. Patients receive standard surgical care using these devices. Outcomes will be measured at multiple time points including baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgery. An interim analysis will occur after 30 patients in each group complete 6 months of follow-up. Participants will attend follow-up visits to assess safety, clinical performance, and functional outcomes using tools like the Disabilities of the Arm Shoulder and Hand short form (QuickDASH) and Patient-Reported Outcomes Measurement Information System (PROMIS). Surgeons' experience and device utility will be surveyed immediately after surgery. Safety monitoring continues up to 24 months, with specific follow-up after device removal for hook plate patients. The total study duration extends to 2 years after surgery.
CONDITIONS
Brief Title
Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Unilateral clavicle injury with primary surgical treatment within 21 days using a DPS VA-LCP Clavicle Plate
- Use of VA-LCP Clavicle Plates 2.7 for clavicle bone fragment fixation
- Use of VA-LCP Clavicle Hook Plates 2.7 for lateral clavicle fractures or acromioclavicular joint dislocations
- Use of VA-LCP Clavicle Button Hook Plates 2.7 for acromioclavicular joint dislocations
- Ability to attend postoperative follow-up visits
- Patient informed consent obtained according to approved procedures
You will not qualify if you...
- Stable clavicle fractures
- Systemic infection or infection localized to the implant site
- Concomitant nerve or blood vessel injury
- Polytrauma with injury severity score of 16 or higher
- Body mass index of 40 or higher
- Uncontrolled severe systemic disease or terminal illness
- Intraoperative decision to use a different implant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Implementation
Duration - Surgical procedure day
Participants undergo surgical treatment using the DPS VA-LCP® Clavicle Plate 2.7 System or Clavicle Hook Plate 2.7 System for fixation of clavicle fractures or acromioclavicular joint dislocations.
1 surgery visit (in-person)
Post-operative Follow-up
Duration - Up to 24 months for clavicle plate and up to 12 months after device removal for clavicle hook plate
Participants have follow-up visits according to standard of care to evaluate safety, clinical performance, and functional outcomes after surgery.
Visits at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgery
Trial Site Locations
Total: 7 locations
1
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
2
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
3
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
4
Klinik Ottakring
Vienna, Austria, 1160
Actively Recruiting
5
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
6
Universitätsklinikum Münster
Münster, Germany, 48149
Actively Recruiting
7
Luzerner Kantonsspital
Lucerne, Switzerland, 6000
Actively Recruiting
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Research Team
M
Marco Minoia, PhD
M
Maria Clara Medina Giner
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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