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Compares treatment options for Proximal Humerus Fracture
Official title Two- Part Proximal Humerus - Conservative vs Operative
ClinicalTrials.gov ID: NCT04106674
What this study is testing
- What it's testing
- The proximal humerus fracture (PHFs) is the third most common fracture type in the elderly, and represents 5% of the overall fractures. The incidence is increasing.
- 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 60 to 85. Healthy volunteers may be eligible.
You may be able to join if
- -The study-design is a single center single blinded assigned by chance controlled trial (RCT) with 3 arms. Patients admitted to Akershus University...
- Patients \> 60 years and \<85 years
- More than 50% displacement between head or shaft or 50⁰ angulation of the head against the shaft in Y-projection or more than 45 ˚ valgus or more...
- Patient with tuberculum majus or minor fractures which displaced \<5mm can be included as long as points 1 and 2 above are fulfilled.
You likely can't join if
- Refusal to participate in the study
- Fracture more than 3 weeks old
- No contact btw head and shaft
- Ipsilateral damage that will influence the recovery and scoring systems
- Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity. This is up to the treating surgeon to decide
- Pathological fracture or previous fracture of the same proximal humerus
See the full eligibility criteria
- -The study-design is a single center single blinded assigned by chance controlled trial (RCT) with 3 arms. Patients admitted to Akershus University Hospital with a displaced 2-part proximal humeral fracture of OTA/ AO...
- Patients \> 60 years and \<85 years
- More than 50% displacement between head or shaft or 50⁰ angulation of the head against the shaft in Y-projection or more than 45 ˚ valgus or more than 30˚ varus of the Head Shaft Angle (HSA).
- Patient with tuberculum majus or minor fractures which displaced \<5mm can be included as long as points 1 and 2 above are fulfilled.
- Refusal to participate in the study
- Fracture more than 3 weeks old
- No contact btw head and shaft
- Ipsilateral damage that will influence the recovery and scoring systems
- Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity. This is up to the treating surgeon to decide
- Pathological fracture or previous fracture of the same proximal humerus
- Multitrauma or "multifractured patient"
- Neurovascular injury
- Open fracture
- Noncompliance, dementia and/ or institutionalized
- Congenital anomaly
- Ongoing infectious process around the incision site for osteosynthesis
- Systemic disease that may influence healing processes or scoring systems (in example Rheumatoid arthritis/Multiple sclerosis/ poorly controlled DM)
- Fracture dislocation
- Substance abuse
- Inability to read and understand Norwegian
- Patients not residing in our catchment area
- Patients with a diameter of the humerus to small for nailing, will be allocated to the Philos-group.
- Any medical condition that excludes surgical treatment, including patients with ASA 3 or 4 that are considered too ill to go through surgery.
The study team makes the final eligibility decision.
Where it's taking place
- Lørenskog, Oslo, Norway
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 60 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lørenskog, Oslo, Norway. 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.