Scandinavian Humeral Diaphyseal Fracture Trial

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

Interventions

PROCEDURE

Surgical treatment

We anticipate that surgical treatment will include plate osteosynthesis (MIPO and ORIF), intramedullary nailing (antegrade and retrograde) and external fixation. Plate and nail types, screw configuration and surgical approaches will be decided by the surgeon. The procedure will be conducted or supervised by a senior consultant.

DEVICE

Non-surgical treatment

Non-surgical treatment will include sugar tong, splint, plaster splints, hanging casts, or functional bracing as the Sarmiento brace and will be worn until a surgeon removes it. If the surgeon deems it appropriate, participants will be offered to undergo early secondary surgery with a surgical procedure of their choice. The participants will be recorded and the reason will be noted. We anticipate the surgical procedures will be similar to the previous mentioned and perhaps with the addition of bone graft.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Sahlgrenska University Hospital

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Hospital of Southern Jutland

  collaborator OTHER

• Slagelse Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• University Hospital, Umeå

  collaborator OTHER

• Nordsjaellands Hospital

  collaborator OTHER

• Holbaek Sygehus

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Copenhagen University Hospital at Herlev

  collaborator OTHER

• University Hospital Bispebjerg and Frederiksberg

  collaborator OTHER

• Viborg Regional Hospital

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Danderyd Hospital

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Kolding Sygehus

  lead OTHER

Principal Investigators

• Bjarke Viberg, MD, PhD · Hospital Lillebaelt

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-04

Primary Completion

2025-12-31

Completion

2031-07-31

Countries

• Denmark
• Finland
• Norway
• Sweden

Study Locations