A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of Clavicle Plates
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Clavicle Fracture
- Sponsor
- Arthrex, Inc.
- Locations
- 2
- Primary Endpoint
- To assess a change in Veterans Rand 12-Item Health Survey (VR-12)
- Status
- Withdrawn
- Last Updated
- 2 years ago
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).
Investigators
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.
Outcomes
Primary Outcomes
To assess a change in Veterans Rand 12-Item Health Survey (VR-12)
Time Frame: 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
To assess a change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
Time Frame: 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
Time Frame: Preoperatively, 3 months, 6 months and 12 months postoperatively
Patient reported pain scale 0-10 point scale (0 min,10 max)