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

Arthrex, Inc.

Overview

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).

Study Type

OBSERVATIONAL

Conditions

Clavicle Fracture

Interventions

Arthrex Clavicle PlatesDEVICE

Arthrex Clavicle Plate for treatment of clavicle fractures

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Sierra Pacific Orthpaedic CenterMedical Group, Inc

Fresno, California, United States

Panorama Orthopedics & Spine Center, PC

Golden, Colorado, United States

Outcomes

Primary Outcomes

To assess a change in Visual Analogue Scale (VAS) survey

Patient reported pain scale 0-10 point scale (0 min,10 max)

Time frame: 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

Time frame: 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.

Time frame: Preoperatively, 3 months, 6 months and 12 months postoperatively

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.