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

Official title

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

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.

Detailed description

Common problems with existing clavicular plates are poor plate 'fit,' unbalance fixation, plate prominence, associated soft tissue irritation, subacromial pain, plate and/or fixation failure (due to unbalanced fixation) and high reoperation rate (for plate removal) \[1-3\]. The newly developed DePuy Synthes (DPS) variable angle locking compression plate (VA-LCP®) Clavicle 2.7 System was designed to address these problems. The system consists of lateral, shaft and medial plates and hook plates of different sizes to cover a wide variation in clavicular morphology and diverse fracture, fracture-dislocation and dislocation indications.

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.

Interventions

• Device 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 typ

Primary outcome measures

• 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]
• Clinical performance [Time frame: Through study completion, an average of 1 year]
• Utility in terms of surgeons' experience [Time frame: Assessed immediately after the surgery]
• Surgical time [Time frame: Assessed immediately after surgeries]
• Fluoroscopy time [Time frame: Assessed immediately after surgeries]
• The Disabilities of the Arm Shoulder and Hand short form (QuickDASH) [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]
• Patient-Reported Outcomes Measurement Information System (PROMIS) [Time frame: Patients treated with clavicle plate: From baseline up to 24 months after device implantation surgery; Patients treated with clavicle hook plate: From baseline until device removal surgery (approximately 3months) and up to 12 months after device removal]

Eligibility criteria

Inclusion 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

United States · 3 centers

• Corewell Health — Grand Rapids
• Atrium Health Wake Forest Baptist — Winston-Salem
• Prisma Health Richland Hospital — Columbia

Germany · 2 centers

• Universitätsklinikum Freiburg — Freiburg im Breisgau
• Universitätsklinikum Münster — Münster

Austria · 1 center

• Klinik Ottakring — Vienna

Switzerland · 1 center

• Luzerner Kantonsspital — Lucerne

Publications

• Jaeger M, Sussiek J, Beeres F, Carroll E, Conlan T, Cunningham D, Arnhold R, Lambert S. Observational case series on the clinical performance of the Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 systems: a study protocol. Front Surg. 2026 Jan 8;12:1694295. doi: 10.3389/fsurg.2025.1694295. eCollection 2025. PMID 41583835

Identifiers

NCT: NCT04921865 · VA Clavicle

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗