Comparing surgical and non-surgical treatments for humeral shaft fractures
Scandinavian Humeral diAphyseal Fracture Trial - A Pragmatic Randomized Controlled Trial
NA · Kolding Sygehus · NCT04574336
This study is testing whether surgery or non-surgery works better for adults with broken upper arm bones to help them recover and regain use of their arm.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 287 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kolding Sygehus (other) |
| Locations | 22 sites (Aabenraa and 21 other locations) |
| Trial ID | NCT04574336 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial aims to evaluate the effectiveness of surgical fixation versus non-surgical treatment for adults with acute humeral shaft fractures. Participants will be divided into two age groups, with different timelines for identifying and treating delayed union based on age-related bone healing rates. The primary outcome will be assessed using the Disability of Arm, Shoulder and Hand (DASH) score at 52 weeks, while secondary outcomes will include earlier DASH scores, pain levels, and elbow range of motion. The trial will involve 287 participants across various trauma centers in Denmark, Sweden, and Norway.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years and older with an acute humeral shaft fracture who can provide informed consent and communicate in Danish, Swedish, or Norwegian.
Not a fit: Patients with undisplaced shaft fractures or those with fractures involving the proximal or distal ends of the humerus will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment approach for humeral shaft fractures, potentially improving recovery outcomes for patients.
How similar studies have performed: Other studies have explored surgical versus non-surgical treatments for fractures, but this specific approach focusing on humeral shaft fractures with age-related considerations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aabenraa and 21 other locations
- Aabenraa Hospital — Aabenraa, Denmark (RECRUITING)
- Aarhus Hospital — Aarhus, Denmark (RECRUITING)
- Bispebjerg Hospital — Copenhagen, Denmark (RECRUITING)
- Hvidovre Hospital — Copenhagen, Denmark (RECRUITING)
- Esbjerg Hospital — Esbjerg, Denmark (RECRUITING)
- Aalborg-Farsø Hospital — Farsø, Denmark (RECRUITING)
- Herlev-Gentofte Hospital — Gentofte Municipality, Denmark (RECRUITING)
- New North Zealand Hospital — Hillerød, Denmark (RECRUITING)
- Holbæk Hospital — Holbæk, Denmark (RECRUITING)
- Kolding Hospital — Kolding, Denmark (RECRUITING)
- Zealand University — Køge, Denmark (RECRUITING)
- Odense Hospital — Odense, Denmark (RECRUITING)
- Slagelse Hospital — Slagelse, Denmark (RECRUITING)
- Viborg Regional Hospital — Viborg, Denmark (RECRUITING)
- Helsinki University Hospital — Helsinki, Finland (RECRUITING)
- Tampere University Hospital — Tampere, Finland (RECRUITING)
- Oslo University Hospital (Ullevål) — Oslo, Norway (RECRUITING)
- Stanvanger University Hospital — Stavanger, Norway (RECRUITING)
- Danderyd University Hospital — Stockholm, Sweden (RECRUITING)
- Karolinska University Hospital — Stockholm, Sweden (RECRUITING)
- Umeå University Hospital — Umeå, Sweden (RECRUITING)
- Uppsala University Hospital — Uppsala, Sweden (RECRUITING)
Study contacts
- Study coordinator: Dennis Karimi, M.D
- Email: denniskarimi@gmail.com
- Phone: +45 76363400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fracture Humerus of Shaft, Humeral shaft fracture, Diaphysis, Fracture fixation, Fracture Healing, Aged, Randomized Controlled Trial, Comparative study