Comparing surgical and non-surgical treatments for shoulder fractures in middle-aged adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine whether surgical treatment leads to better functional outcomes compared to non-surgical treatment for displaced proximal humerus fractures in adults aged 50 to 65. Participants will be randomly assigned to receive either surgical intervention or non-surgical care, with their progress monitored through questionnaires at 6 months, 1 year, and 2 years. The primary outcome will be assessed using the Oxford Shoulder Score at the 12-month mark, while secondary outcomes will include additional assessments at various time points. The study also seeks to characterize the patient population regarding fracture morphology and clinical frailty.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged between 50 and 65 years with a displaced PHF assessed to be constructible by the treating surgeon after a low-energy trauma will be considered for eligibility.
* Patients should be cognitively capable of answering the follow-up questionnaires.

Exclusion Criteria:

* The patient does not understand written and spoken native language (Danish or Finnish/Swedish)
* Inability to give informed consent
* Fractures assessed to be unreconstructedly by the treating surgeon
* Isolated tuberosity fracture, fracture dislocations, open fractures, and fractures with involvement of the articular surface
* Less than 25% contact between head fragment and metaphysis/diaphysis measured at two perpendicular radiographs at two weeks.
* Pathological fractures or previous fractures in the same proximal humerus
* Concomitant fractures, which could influence the outcome
* Paralysis in upper extremity

Where it's running

• Centre for Evidence-Based Orthopaedics, Zealand University Hospital
  Køge, Region Sjælland, Denmark Recruiting
• Tampere University Hospital
  Tampere, Finland Not yet recruiting

Study contacts

• Principal investigator: Line Løjbert Houkjær, M.D. — Center for evidensbaseret ortopædkirurgi, Sjællands Universitets Hospital, Køge.
• Study coordinator: Line Løjbert Houkjær, M.D., ph.d.-student
• Email: lihol@regionsjaelland.dk
• Phone: 61711681

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• 3-D classification for proximal humerus fractures

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.