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Scandinavian Humeral Diaphyseal Fracture Trial

RecruitingNAAges 18 Years - anyAllKolding Sygehus
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In plain words

What the trial is, and whether it could suit you

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. The definition of delayed union differs in the young and elderly population to consider dissimilarity in bone healing rates and the timepoint for crossover is therefor different between the groups. Participants will be randomized 1:1 between non-surgical treatment and surgical treatment. The primary outcome is the Disability of Arm, Shoulder and Hand (DASH) score at 52 weeks, and is assessor blinded. The secondary outcomes are DASH score earlier than 52

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
1. 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) 2. Treatment within 14 days from trauma 3. Age 18-64 years for SHAFT-Y and ≥65 years for SHAFT-E 4. 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 extensions involving the proximal humerus will not be included. Isolated fractures to the proximal or the distal end of the humerus are not eligible for screening. The proximal and distal end segments of the humerus are defined by squares of which the sides are the widest length of the epiphysis/metaphysis in question on the anterior-posterior view. Exclusion criteria 1. Inability to give informed consent 2. Undisplaced shaft fracture (less than a cortex-wide displacement in all radiographic plane) 3. Vascular injury in ipsilateral arm 4. Polytrauma (defined as a trauma with one or more concurrent fractures to the upper extremities or other trauma absolute indications for surgical intervention) 5. Pathological fracture 6. Open fracture 7. BMI \> 40 8. Health conditions preventing either treatment
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What it tests

  • Surgical treatment
  • Non-surgical treatment
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Where

22 sites
Aabenraa Hospital
Aabenraa, Denmark
Aarhus Hospital
Aarhus, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Hvidovre Hospital
Copenhagen, Denmark
Esbjerg Hospital
Esbjerg, Denmark
Aalborg-Farsø Hospital
Farsø, Denmark
Herlev-Gentofte Hospital
Gentofte Municipality, Denmark
New North Zealand Hospital
Hillerød, Denmark

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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