Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems
NCT ID: NCT04921865
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
76 participants
OBSERVATIONAL
2024-07-10
2029-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients treated with the DPS VA-LCP® Clavicle Plate 2.7 System or Hook Plate 2.7 System
Any patient undergoing surgical treatment for the fixation of clavicle bone fragments and acromioclavicular joint dislocations using the DPS VA-LCP® Clavicle Plate 2.7 System or DPS VA-LCP® Clavicle Clavicle Hook Plate 2.7 .
DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System
The DPS VA-LCP® Clavicle Plate 2.7 System is indicated for the fixation of clavicle bone fragments. The system consists of three plate types: lateral, shaft, and medial, each available in different sizes and materials (titanium alloy and stainless steel). Each plate is available in left and right.
The DPS VA-LCP® Clavicle Clavicle Hook Plate 2.7 System is indicated or the fixation of lateral clavicle fractures and AC joint dislocations. The Clavicle Hook Plate system consists of three plate types: long, short and button plates.
Interventions
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DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System
The DPS VA-LCP® Clavicle Plate 2.7 System is indicated for the fixation of clavicle bone fragments. The system consists of three plate types: lateral, shaft, and medial, each available in different sizes and materials (titanium alloy and stainless steel). Each plate is available in left and right.
The DPS VA-LCP® Clavicle Clavicle Hook Plate 2.7 System is indicated or the fixation of lateral clavicle fractures and AC joint dislocations. The Clavicle Hook Plate system consists of three plate types: long, short and button plates.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AO Innovation Translation Center
OTHER
Responsible Party
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Principal Investigators
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Simon Lambert
Role: PRINCIPAL_INVESTIGATOR
University College London Hospital
Locations
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Corewell Health
Grand Rapids, Michigan, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Prisma Health Richland Hospital
Columbia, South Carolina, United States
Klinik Ottakring
Vienna, , Austria
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitätsklinikum Münster
Münster, , Germany
Luzerner Kantonsspital
Lucerne, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VA Clavicle
Identifier Type: -
Identifier Source: org_study_id
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