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

AO Innovation Translation Center

Status: Enrolling

Conditions: Acromioclavicular Joint; Fracture; Clavicle

Treatments: Device: DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System

Study type: Observational

Funder types: Other

Identifiers

NCT04921865

VA Clavicle

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

76 participants in 1 patient group

Patients treated with the DPS VA-LCP® Clavicle Plate 2.7 System or Hook Plate 2.7 System

Description:

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 .

Treatment:

Device: DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System