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

The objective of the registry is to evaluate the continued safety and performance of Arthrex Clavicle Plates used to treat clavicle fractures.

Study Overview

• Status: Withdrawn
• Conditions: Clavicle Fracture
• Intervention / Treatment: Device: Arthrex Clavicle Plates

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Sierra Pacific Orthpaedic CenterMedical Group, Inc
  • Colorado
    • Golden, Colorado, United States, 80401
      • Panorama Orthopedics & Spine Center, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Arthrex Clavicle Plates are intended to be used in the general population for clavicle fractures.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Arthrex Clavicle Plates; Arthrex Clavicle Plate for treatment of clavicle fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Arthrex, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AIRR-0005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No