UnknownNot Applicable

Plating Clavicle Fractures

United States90 participantsStarted 2008-10

Plain-language summary

The anterior-inferior clavicle plate position will have a lower rate of soft tissue irritation that limits activity and/or requires hardware removal compared to superior plate position.

Who can participate

Age range

18 Years – 65 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: * Active duty, Reservists, National Guard service members * completely displaced shaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments) * a fracture involving the middle third of the clavicle (a fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment) * chronic nonunion and malunion fractures * no medical contraindications to general anesthesia * provided informed consent. Exclusion Criteria: * an age of less than eighteen years or greater than sixty five years * a fracture in the proximal or distal third of the clavicle not amenable to plating * a pathological fracture * an associated head injury (a Glasgow Coma Scale score of \<15 at 21 days after injury) * an inability to comply with followup * a medical contraindication to surgery and/or anesthesia (such as heart disease, renal failure, or active chemotherapy) * a lack of consent.

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

Less irritation with anterior-inferior plating and less need for hardware removal.

Timeframe: 2 years

Trial details

NCT IDNCT00871468

SponsorUnited States Army Institute of Surgical Research

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2018-08

View on ClinicalTrials.gov More Clavicle Fracture, Non Union/Malunion trials

Who can participate

Age range

18 Years – 65 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.