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

Study Overview
=================
Brief 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).

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

Conditions
-----------------
Clavicle Fracture

Intervention / Treatment
-----------------
* Device: Arthrex Clavicle Plates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject requires surgery using the Arthrex Clavicle Plate for clavicle fracture. The subject is 18 years of age or over. The subject is not considered a vulnerable subject (i.e., child, pregnant, nursing, prisoner, or ward of the state). Subject signed informed consent and is willing and able to comply with all study requirements Exclusion Criteria: Insufficient quantity or quality of bone. Blood supply limitations and previous infections, which may retard healing. Foreign-body sensitivity. Any active infection or blood supply limitations. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period. Subjects that are skeletally immature.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 50 subjects, male and female, at least 18 years of age<br>50 subjects who are candidates for surgery using the Arthrex Clavicle Plate for treatment of clavicle fractures. | Device: Arthrex Clavicle Plates<br>* Arthrex Clavicle Plate for treatment of clavicle fractures<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess a change in Visual Analogue Scale (VAS) survey | Patient reported pain scale 0-10 point scale (0 min,10 max) | Preoperatively, 3 months, 6 months and 12 months postoperatively | 
| To assess a change in Veterans Rand 12-Item Health Survey (VR-12) | Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring scores up | Preoperatively, 3 months, 6 months and 12 months postoperatively | 
| To assess a change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) | ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. | Preoperatively, 3 months, 6 months and 12 months postoperatively |