WithdrawnNot Applicable

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

Stopped: The study was suspended and terminated.

United States0Started 2021-05-20

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess a change in Visual Analogue Scale (VAS) survey

Timeframe: Preoperatively, 3 months, 6 months and 12 months postoperatively

To assess a change in Veterans Rand 12-Item Health Survey (VR-12)

Timeframe: Preoperatively, 3 months, 6 months and 12 months postoperatively

To assess a change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)

Timeframe: Preoperatively, 3 months, 6 months and 12 months postoperatively

Trial details

NCT IDNCT04986553

SponsorArthrex, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-07-30

View on ClinicalTrials.gov More Clavicle Fracture trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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.

What they're measuring

To assess a change in Visual Analogue Scale (VAS) survey

Timeframe: Preoperatively, 3 months, 6 months and 12 months postoperatively

To assess a change in Veterans Rand 12-Item Health Survey (VR-12)

Timeframe: Preoperatively, 3 months, 6 months and 12 months postoperatively

To assess a change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)

Timeframe: Preoperatively, 3 months, 6 months and 12 months postoperatively