TerminatedNot Applicable

RSA vs. Nonop for 3 & 4-Part Proximal Humerus Fractures

Stopped: Slower than expected enrollment.

United States4 participantsStarted 2018-08-01

Plain-language summary

There is currently no consensus amongst orthopedic specialists on the best way to treat 3- and 4-part proximal humerus fractures. No surgery and surgery with a type of shoulder replacement called a reverse total shoulder arthroplasty are two options that many orthopedists use. This study is being performed to evaluate the differences in short- and long-term pain and functional outcomes between patients who are treated with these two different options.

Who can participate

Age range

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 * Displaced 3- and 4-part proximal humerus fractures. * Age greater than or equal to 65 years old. Exclusion Criteria * Less than 65 years old. * Medical comorbidities precluding surgical treatment or anesthesia * Dementia or inability to provide adequate follow up. * Pathologic fractures * Open fractures * Associated injuries: fracture dislocations, multiple or complex injuries of the ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.

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

Function as described by ASES score at 1 year follow-up.

Timeframe: 2 year follow-up

Trial details

NCT IDNCT03599336

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-29

View on ClinicalTrials.gov More Humerus Fracture trials