Brief Summary

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 weeks, EQ-5D-5L, pain assessed by visual analogue score, Constant-Murley score including elbow range of motion and anchor-questions collected at all timepoints throughout the trial. All complications will be reported including; infection, nerve or vascular injury, surgical revisions (implant malpositioning, hardware failure, aseptic loosening and peri-implant fracture), major adverse cardiovascular events, other major adverse events and mortality. SHAFT will provide information on the effectiveness of two standard treatments for humeral shaft fractures, while taking the dilemmas within the population into account.

Conditions

• Fracture Humerus of Shaft

Intervention / Treatment

• Procedure: Surgical treatment
• Device: Non-surgical treatment

Primary Outcome Measures

• Disabilities of the Arm, Shoulder and Hand (DASH) score (52 weeks)
  A patient-reported outcome measure specific for physical function and symptoms of the upper limb (Disability of Arm, Shoulder and Hand-DASH). Scores range from 0 (no disability) to 100 (most severe disability)

Countries

Denmark, Finland, Norway, Sweden

Locations and Investigators

• Aabenraa Hospital, Aabenraa, Denmark (Recruiting)
  • Jesper Schønnemann, M.D
• Aarhus Hospital, Aarhus, Denmark (Recruiting)
  • Per Gundtoft, M.D.
• Bispebjerg Hospital, Copenhagen, Denmark (Recruiting)
  • Michael Kuhlmann, M.D
• Hvidovre Hospital, Copenhagen, Denmark (Recruiting)
  • Søren Kring, M.D
• Esbjerg Hospital, Esbjerg, Denmark (Recruiting)
  • Jens Knak
• Aalborg-Farsø Hospital, Farsø, Denmark (Recruiting)
  • Esben Pedersen, M.D
• Herlev-Gentofte Hospital, Gentofte, Denmark (Recruiting)
  • Anne-Marie Nyholm
• New North Zealand Hospital, Hillerød, Denmark (Recruiting)
  • Peter Siesing-Mejer, M.D
• Holbæk Hospital, Holbæk, Denmark (Recruiting)
  • Jacob Lagoni, M.D
• Kolding Hospital, Kolding, Denmark (Recruiting)
  • Rasmus Bendtson, M.D.
• Zealand University, Køge, Denmark (Recruiting)
  • Bamo Jalal, M.D
• Odense Hospital, Odense, Denmark (Recruiting)
  • Joakim Jensen, M.D
• Slagelse Hospital, Slagelse, Denmark (Recruiting)
  • Mads Vinding, M.D
• Viborg Regional Hospital, Viborg, Denmark (Recruiting)
  • Srdjan Zivanovic, M.D
• Helsinki University Hospital, Helsinki, Finland (Recruiting)
  • Maire Ratasvuori, M.D., PhD.
• Tampere University Hospital, Tampere, Finland (Recruiting)
  • Antti Launonen, M.D, PhD
• Oslo University Hospital (Ullevål), Oslo, Norway (Recruiting)
  • Tore Fjalestad, M.D:
• Stanvanger University Hospital, Stavanger, Norway (Recruiting)
  • Aksel Paulsen, M.D.
• Danderyd University Hospital, Stockholm, Sweden (Recruiting)
  • Max Gordon, M.D.
• Karolinska University Hospital, Stockholm, Sweden (Recruiting)
  • Yan Li, M.D.
• Umeå University Hospital, Umeå, Sweden (Recruiting)
  • Jonas Sundkvist, M.D.
• Uppsala University Hospital, Uppsala, Sweden (Recruiting)
  • Olof Wolf, M.D.

Study Officials

• Bjarke Viberg, MD, PhD (Study Chair) — Hospital Lillebaelt