Scandinavian Humeral Diaphyseal Fracture Trial
Scandinavian Humeral Diaphyseal Fracture Trial
This study includes adult participants with a humeral shaft fracture. The study is divided
 into two large RCTs which will differ in age cut-off and time interval for cross-over from
 non-surgical to surgical treatment. The trials will include 100 participants each and be
 conducted in hospitals around Denmark, Sweden and Norway.

 The hypothesis is that primary surgical treatment results in less symptoms and better
 function than non-surgical treatment with the option of early identification and treatment
 cross-over of failed treatment. Participants will be randomized 1:1 between non-surgical
 treatment and surgical treatment. The specific procedure is decided by treating
 surgeon/hospital. The primary outcome is the DASH-score after 52 weeks. The secondary
 outcomes include: DASH-score at 26 weeks, EQ-5D-5L, complications, pain, fracture site
 mobility, return to work and willingness to repeat treatment.
The objective is to compare surgical fixation of humeral shaft fracture to non-surgical
 treatment with early identification and treatment of failed treatment.

 The trial is divided into two separate RCT's:

 1. SHAFT-Y for the young with an age cut-off of 18 to 64 years. The early identification
 and treatment of delayed union is set to 6 to 12 weeks

 2. SHAFT-E for the elder with an age cut-off +65 years. The early identification and
 treatment of delayed union is set to 12 to 26 weeks

 The trials are otherwise identical and the primary outcome is the DASH-score at 52 weeks
 after primary intervention. The SHAFT trial is divided into two trials as there is a bimodial
 age distribution with more elderly than young thereby possibly skewing the results if the age
 groups where combined.

 The SHAFT trial will be conducted in hospitals around Denmark, Sweden and Norway.

 Patients admitted to the emergency department in one of the trial sites and fulfil the
 eligibility criterias, will be invited to enroll into the trial. They will be given time to
 consider and be scheduled for a consultation with a trial worker (non-physician) within 7
 days. Written consent will be obtained at the consultation and randomization will occur
 immediately after. If patients do not wish to enroll to the RCT, they will be asked to
 consider enrollment in an observational cohort.

 Treatment will be performed within 14 days after injury

 -  Surgical treatment. The specific treatment is decided by the treating surgeon/department

 -  Non-surgical treatment with the option of early secondary surgery from 6-12 weeks for
 SHAFT-Y and 12-26 weeks for SHAFT-E

 Participants will be assigned to the trial with an allocation of 1:1 to either surgical
 treatment or non-surgical treatment. The trial worker (non-physician) acquires the allocated
 treatment from REDCap and initiates the treatment, either by scheduling the surgery date or
 applying the chosen non-surgical method.

 The total sample size is estimated to 100 participants in each trial and is powered to detect
 a minimal important change (MIC) of 7 points in DASH. The standard deviation(SD) is ±10. The
 investigators used an α-level of 0.05 and β-level of 0.10. The primary sample size
 calculation is based on these assumptions and a total of 43 participants are required per
 group. The allowance of attrition is set to 15%.

 Participants will be included consecutively to an observational group until the sample size
 for the RCT is completed. The trial management committee can decide to pool data from both
 RCTs (SHAFT-E, SHAFT-Y) if recruitment is prolonged.

 Statistical analysis for the study will be performed by an blinded independent statistician.

 Follow-ups are planned at 2 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks.
Inclusion Criteria:

 1. Fracture types 12A-C (OTA/AO classification)

 2. Treatment within 14 days from trauma

 3. Age 18-64 years for SHAFT-Y and +65 years for SHAFT-E

 4. Participants must understand the information given and be able to read and speak
 Danish, Swedish or Norwegian to complete the study paperwork

 Exclusion Criteria:

 1. Inability to give informed consent

 2. Undisplaced shaft fracture (less than a cortex-wide displacement in one radiographic
 plane)

 3. Displaced fractures of the proximal and distal humeral (more than a cortex-wide
 displacement in one radiographic plane)

 4. Vascular injury in ipsilateral arm

 5. Polytrauma

 6. Pathological fracture

 7. Open fracture

 8. Floating shoulder fractures

 9. Floating elbow fractures

 10. BMI > 40

 11. Health conditions preventing treatment