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

NCT04986553 | Withdrawn FDA Device

• 1 other identifier: AIRR-0005
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Clavicle Fracture

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Arthrex Clavicle Plates DEVICE

Arthrex Clavicle Plate for treatment of clavicle fractures

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• The subject requires surgery using the Arthrex Clavicle Plate for clavicle fracture.
• The subject is 18 years of age or over.
• The subject is not considered a vulnerable subject (i.e., child, pregnant, nursing, prisoner, or ward of the state).
• Subject signed informed consent and is willing and able to comply with all study requirements

You may not qualify if:

• Insufficient quantity or quality of bone.
• Blood supply limitations and previous infections, which may retard healing.
• Foreign-body sensitivity.
• Any active infection or blood supply limitations.
• Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
• Subjects that are skeletally immature.

Sponsors & Collaborators

• Arthrex, Inc.: lead

Study Sites (2)

Sierra Pacific Orthpaedic CenterMedical Group, Inc

Fresno, California, 93720, United States

Location

Panorama Orthopedics & Spine Center, PC

Golden, Colorado, 80401, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: August 3, 2021
• Study Start: May 20, 2021
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

US (2)