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

NCT ID: NCT04986553

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-20

Study Completion Date

2023-07-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Clavicle Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Arthrex Clavicle Plates

Intervention Type DEVICE

Arthrex Clavicle Plate for treatment of clavicle fractures

Interventions

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Arthrex Clavicle Plates

Arthrex Clavicle Plate for treatment of clavicle fractures

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arthrex, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sierra Pacific Orthpaedic CenterMedical Group, Inc

Fresno, California, United States

Site Status

Panorama Orthopedics & Spine Center, PC

Golden, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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AIRR-0005

Identifier Type: -

Identifier Source: org_study_id

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