CompletedNot Applicable

Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures

Austria, China, Germany148 participantsStarted 2007-03

Plain-language summary

The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with proximal humerus fractures treated with open reduction and angle-stable plates (Proximal Humeral Internal Locking System - PHILOS).

Who can participate

Age range

50 Years – 90 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: * Radiologically confirmed closed fracture (within 10 days) of the proximal humerus * All dislocated (mod. Neer) proximal humerus fractures except dislocated fractures of the greater and lesser tuberosity * Primary fracture treatment with a PHILOS-plate * Age equal greater than 50 and equal younger than 90 years * Normal function of both shoulders (pre-trauma) according to age * Monotrauma * Willing and able to give written informed consent to participate in the study * Willing and able to participate in the study follow-ups according to the CIP * Willing and able to comply with the postoperative management program * Able to understand and read country national language Exclusion Criteria: * Open proximal humerus fractures * Concomitant contralateral proximal humerus fracture * Previous proximal humerus fracture on either side after the age of 25 * Time to operation \> 10 days * Polytrauma * Cuff-arthropathy of the contralateral proximal humerus * Associated nerve or vessel injury * Regular systemic therapy with corticosteroids due to chronic disease * Legal incompetence * Patient received radio- or chemotherapy prior to, during or within the last year * Currently active cancer * Recent history of substance abuse (i.e. recreational drugs, alcohol) * Prisoner * Currently involved in a pharmaceutical clinical study§ * Has a disease process that would preclude accurate evaluation (e.g. neuromuscular or rheumatic disease, significant psychiatric or metaboli…

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

Local bone quality-related complication

Timeframe: From enrollment to 12 months postoperative

Trial details

NCT IDNCT01143675

SponsorAO Clinical Investigation and Publishing Documentation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2010-04

View on ClinicalTrials.gov More Proximal Humeral Fractures trials

Who can participate

Age range

50 Years – 90 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.