UnknownNot Applicable

Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly

Brazil58 participantsStarted 2016-01

Plain-language summary

This is a randomized trial comparing conservative with surgical treatment (with open reduction and locking plate fixation) for proximal humeral fractures in patients aged more than 60 years.

Who can participate

Age range

60 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: * Proximal humeral fractures, involving humeral head, with at least one of the following parameters: * Head-shaft angle between 100-200° or \>175° on coronal plane; * Shaft translation (on coronal or sagittal plane) \> 1cm; * Tuberosity displacement \> 0,5cm; * Head shaft angulation \>45° in axial or sagittal plane; * Less then 30 days Exclusion Criteria: * No contact between shaft and humeral head * Head-shaft angle \<100° on coronal plane * Articular head fracture with displacement \> 2mm * Fracture-dislocation * Bilateral fracture * Open fracture * Ipsilateral or contralateral superior limb fracture * Pathological fracture (tumors or bone disease, except for osteoporosis) * Previous rotator cuff complete tear * Previous infection * Neurological injury * Previous shoulder surgery * Inability to answer subjective scores

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

Individual relative Constant-Murley score

Timeframe: 2 years

Trial details

NCT IDNCT02913378

SponsorUniversity of Sao Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07

View on ClinicalTrials.gov More Shoulder Fractures trials

Who can participate

Age range

60 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.