Comparing surgical and non-surgical treatments for humeral shaft fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Dennis Karimi, M.D
• Email: denniskarimi@gmail.com
• Phone: +45 76363400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ultrasound check of the radial nerve after a humeral shaft fracture

  This tests whether an early high-resolution ultrasound can detect radial nerve damage in adults with humeral shaft fractures, including those with wrist and hand weakness.

  Recruiting Istanbul Medeniyet University · Istanbul, Kars · NCT07286734

• Early surgical fixation for arm fractures in elderly patients

  This study tests if early surgery for arm fractures helps older patients feel and function better compared to those who only get standard care.

  Recruiting Fraser Orthopaedic Research Society · New Westminster, British Columbia · NCT06605482

• EASY Algorithm: Bedside ultrasound to screen children aged 5 to 15 for elbow fractures

  This project will test whether a quick bedside ultrasound can reliably show or rule out elbow fractures in children aged 5 to 15 after an injury.

  Recruiting at 2 sites Charite University, Berlin, Germany · Amberg and 12 other locations · NCT07429344

• Ultrasound to find elbow fractures in children

  This trial tests whether using bedside ultrasound instead of X-rays helps children who come to the ER with elbow pain.

  Recruiting Nemours Children's Clinic · Orlando, Florida · NCT07212036

• Pain control options after elbow surgery in children

  This study is testing two different ways to manage pain after elbow surgery in kids to see which one works better and uses fewer strong medications.

  Recruiting Phase 4 University of California, Los Angeles · Los Angeles, California · NCT03759028

• Tipmed Shoulder Prosthesis PMCF: safety and outcomes after shoulder replacement

  This PMCF study tests the safety and function of the Tipmed shoulder prosthesis in adults undergoing reverse shoulder or hemiarthroplasty in real-world practice.

  Recruiting TIPMED Medical Device Manufacturing Ltd. Co. · Balıkesir and 3 other locations · NCT07678034

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.