Clavicle Fracture
Conditions
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).
Interventions
DEVICEArthrex Clavicle Plates
Arthrex Clavicle Plate for treatment of clavicle fractures
Sponsors
Arthrex, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject requires surgery using the Arthrex Clavicle Plate for clavicle fracture. 2. The subject is 18 years of age or over. 3. The subject is not considered a vulnerable subject (i.e., child, pregnant, nursing, prisoner, or ward of the state). 4. Subject signed informed consent and is willing and able to comply with all study requirements
Exclusion criteria
1. Insufficient quantity or quality of bone. 2. Blood supply limitations and previous infections, which may retard healing. 3. Foreign-body sensitivity. 4. Any active infection or blood supply limitations. 5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period. 6. Subjects that are skeletally immature.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess a change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) | Preoperatively, 3 months, 6 months and 12 months postoperatively | 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. |
| To assess a change in Visual Analogue Scale (VAS) survey | Preoperatively, 3 months, 6 months and 12 months postoperatively | Patient reported pain scale 0-10 point scale (0 min,10 max) |
| To assess a change in Veterans Rand 12-Item Health Survey (VR-12) | Preoperatively, 3 months, 6 months and 12 months postoperatively | Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring scores up |
Countries
United States
Outcome results
None listed