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

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
AO Innovation Translation Center
Study ID
NCT04921865
Status
Recruiting
Apply to this trial

Conditions

  • Acromioclavicular Joint
  • Clavicle
  • Fracture

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jul 10, 2024
Status verified
Aug 2025
Primary completion
Jan 31, 2027
Completion
Sep 30, 2029

Study Design

Enrollment
76 participants (estimated)

Arms

  • Arm: 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 .

Primary Outcome Measure

Safety aspects [ Time Frame: Patients treated with clavicle plate: From baseline up to 24 months after surgery; Patients treated with clavicle hook plate: From baseline until device removal (approximately 3months) and up to 12 months after device removal ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Corewell HealthGrand RapidsMichigan49503
Todd Conlan
[email protected]
330-265-3097
Todd Conlan (PRINCIPAL_INVESTIGATOR)
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157
Eben Carroll, Prof Dr
[email protected]
Prisma Health Richland HospitalColumbiaSouth Carolina29203
Daniel Cunningham, MD
[email protected]

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Corewell Health· Grand Rapids, MIAtrium Health Wake Forest Baptist· Winston-Salem, NCPrisma Health Richland Hospital· Columbia, SC

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