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

Clavicle Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04986553
• Other study ID #: AIRR-0005
• Status: Withdrawn
• Start date: May 20, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: January 2024
• Source: Arthrex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clavicle Fracture

Intervention

Device:
• Arthrex Clavicle Plates
Arthrex Clavicle Plate for treatment of clavicle fractures

Locations

Country	Name	City	State
United States	Sierra Pacific Orthpaedic CenterMedical Group, Inc	Fresno	California
United States	Panorama Orthopedics & Spine Center, PC	Golden	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Arthrex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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