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New treatment option for Fracture Humerus of Shaft
Official title Scandinavian Humeral Diaphyseal Fracture Trial
ClinicalTrials.gov ID: NCT04574336
What this study is testing
- What it's testing
- This pragmatic multicenter randomized controlled trial (RCT) includes adult participants with an acute humeral shaft fracture to compare surgical fixation of humeral shaft fracture to non-surgical treatment with early identification and treatment of delayed union by a patient-reported outcome after 52 weeks. The trial population of 287 participants The trial population is divided in two age-groups due to the changes in DASH score by age.
- 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 18 and older
You may be able to join if
- Fracture types 12A-C (OTA/AO classification) a. Includes minimal displaced extra-articular fracture extensions to the proximal humerus (less than a 1...
- Treatment within 14 days from trauma
- Age 18-64 years for SHAFT-Y and ≥65 years for SHAFT-E
- Patients must understand the information given and be able to read and speak Danish, Swedish or Norwegian to complete the study paperwork All...
You likely can't join if
- Inability to give informed consent
- Undisplaced shaft fracture (less than a cortex-wide displacement in all radiographic plane)
- Vascular injury in ipsilateral arm
- Polytrauma (defined as a trauma with one or more concurrent fractures to the upper extremities or other trauma absolute indications for surgical...
- Pathological fracture
- Open fracture
See the full eligibility criteria
- Fracture types 12A-C (OTA/AO classification) a. Includes minimal displaced extra-articular fracture extensions to the proximal humerus (less than a 1 cm or 45 degree angulation)
- Treatment within 14 days from trauma
- Age 18-64 years for SHAFT-Y and ≥65 years for SHAFT-E
- Patients must understand the information given and be able to read and speak Danish, Swedish or Norwegian to complete the study paperwork All fracture extensions involving the distal humerus and displaced fracture...
- Inability to give informed consent
- Undisplaced shaft fracture (less than a cortex-wide displacement in all radiographic plane)
- Vascular injury in ipsilateral arm
- Polytrauma (defined as a trauma with one or more concurrent fractures to the upper extremities or other trauma absolute indications for surgical intervention)
- Pathological fracture
- Open fracture
- BMI \> 40
- Health conditions preventing either treatment
The study team makes the final eligibility decision.
Where it's taking place
- Aabenraa, Denmark
- Aarhus, Denmark
- Copenhagen, Denmark
- Esbjerg, Denmark
- Farsø, Denmark
- Gentofte Municipality, Denmark
- Hillerød, Denmark
- Holbæk, Denmark
- Kolding, Denmark
- Køge, Denmark
- Odense, Denmark
- Slagelse, Denmark
- Viborg, Denmark
- Helsinki, Finland
- Tampere, Finland
- Oslo, Norway
- Stavanger, Norway
- Stockholm, Sweden
- Umeå, Sweden
- Uppsala, Sweden
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aabenraa, Denmark; Aarhus, Denmark; Copenhagen, Denmark; Esbjerg, Denmark; Farsø, Denmark; Gentofte Municipality, Denmark and 14 more location(s). 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.