CompletedNot Applicable

Rehabilitation Following Displaced Proximal Humerus Fractures

Denmark60 participantsStarted 2022-05-05

Plain-language summary

Proximal humerus fractures (PHFs) are the third most common non-vertebral fractures in the elderly. Most elderly experience loss of function following a PHF regardless of treatment. A Cochrane review from 2015 concluded that surgical management is not superior to non-surgical management, and that the optimal non-surgical management after PHF is not known. Therefore, the aim of this study is to evaluate the effectiveness of usual rehabilitation care after displaced PHF compared with one-time physiotherapy instruction.

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: • Patients aged 60 years or above with displaced PHFs (Neer's definition) including 2-, 3-, or 4-part fractures after a low energy trauma will be recruited. Prior to first visit in the outpatient clinic all patients with PHFs will be screened for eligibility based on initial radiographs and medical records by an experienced orthopaedic consultant (senior author SB) at Zealand University Hospital, Køge, Denmark. The senior author classifies fracture categories. • Patients should be cognitively capable of answering patient-reported outcome measures. Exclusion Criteria: * Dependent on daily personal care for basic activities of daily living * Diagnosed with dementia or institutionalized * Does not understand written and spoken guidance in Danish * Pathological fracture or previous fracture in the same proximal humerus * Concomitant injury or fracture. * Polytrauma, high-energy trauma, or multiple fractures * Fracture dislocation or articular surface fracture * Isolated tuberosity fracture * Fractures not expected to heal by non-surgical treatment (no bony contact between head and shaft in both views) * The senior author considers the patient unsuitable to attend the study for medical reasons (substance abuse, affective or psychotic disorders, apoplexy, chronic pain, malignant disease) * Symptomatic glenohumeral osteoarthritis, rheumatoid arthritis, or rotator cuff-arthropathy

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

Oxford Shoulder Score (OSS)

Timeframe: 6 months

Trial details

NCT IDNCT05302089

SponsorZealand University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-20

View on ClinicalTrials.gov More Shoulder Fractures trials