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

Arthrex

Status: Withdrawn

Conditions: Clavicle Fracture

Treatments: Device: Arthrex Clavicle Plates

Study type: Observational

Funder types: Industry

Identifiers

NCT04986553

AIRR-0005

Details and patient eligibility

About

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

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

50 subjects, male and female, at least 18 years of age

Description:

50 subjects who are candidates for surgery using the Arthrex Clavicle Plate for treatment of clavicle fractures.

Treatment:

Device: Arthrex Clavicle Plates