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Compares treatment options for Proximal Humeral Fracture
Official title Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years
ClinicalTrials.gov ID: NCT06416618
What this study is testing
- What it's testing
- The goal of this clinical trial is to study whether surgery results in better functional outcomes than non-surgical treatment among patients aged 50-65 with a displaced proximal humerus fracture. The main questions it aims to answer are: Does osteosynthesis result in better patient-reported functional outcomes compared to non-surgical treatment at 12 months follow-up?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 65
You may be able to join if
- 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...
- Patients should be cognitively capable of answering the follow-up questionnaires.
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Køge, Region Sjælland, Denmark
- Tampere, Finland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Køge, Region Sjælland, Denmark; Tampere, Finland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.