NCT04986553

A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of Clavicle Plates

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Arthrex, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the registry is to evaluate the continued safety and performance of Arthrex Clavicle Plates used to treat clavicle fractures.

Detailed description

To assess safety, device-related adverse events will be reported and evaluated over the course of the study. To evaluate the performance imaging of the target area will be evaluated at three months postoperative. Additionally, patient-reported outcomes will be evaluated at three months postoperative, 6 months postoperative, and one year postoperative using the Visual Analogue Scale (VAS), Veterans Rand 12-Item Health Survey (VR-12), and American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES).

Conditions

• Clavicle Fracture

Interventions

Type	Name	Description
DEVICE	Arthrex Clavicle Plates	Arthrex Clavicle Plate for treatment of clavicle fractures

Timeline

• Start date: 2021-05-20
• Primary completion: 2023-07-30
• Completion: 2023-07-30
• First posted: 2021-08-03
• Last updated: 2024-02-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study