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

Withdrawn

• Conditions: Clavicle Fracture
• Interventions: Device: Arthrex Clavicle Plates

• Registration Number: NCT04986553
• Lead Sponsor: Arthrex, Inc.

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).

Study Timeline

• Study Start: 2021-05-20
• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-08-03
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
50 subjects, male and female, at least 18 years of age	Arthrex Clavicle Plates	50 subjects who are candidates for surgery using the Arthrex Clavicle Plate for treatment of clavicle fractures.

Primary Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (2)

Sierra Pacific Orthpaedic CenterMedical Group, Inc; 🇺🇸 Fresno, California, United States

Panorama Orthopedics & Spine Center, PC; 🇺🇸 Golden, Colorado, United States