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The study was suspended and terminated.
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The objective of the registry is to evaluate the continued safety and performance of Arthrex Clavicle Plates used to treat clavicle fractures.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 subjects, male and female, at least 18 years of age | 50 subjects who are candidates for surgery using the Arthrex Clavicle Plate for treatment of clavicle fractures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthrex Clavicle Plates | Device | Arthrex Clavicle Plate for treatment of clavicle fractures |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Arthrex Clavicle Plates are intended to be used in the general population for clavicle fractures.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sierra Pacific Orthpaedic CenterMedical Group, Inc | Fresno | California | 93720 | United States | ||
| Panorama Orthopedics & Spine Center, PC |
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| Golden |
| Colorado |
| 80401 |
| United States |