Scandinavian Humeral Diaphyseal Fracture Trial
ConditionFracture Humerus of Shaft
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKolding Sygehus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fracture types 12A-C (OTA/AO classification)
Treatment within 14 days from trauma
Age 18-64 years for SHAFT-Y and ≥65 years for SHAFT-E
Patients must understand the information given and be able to read and speak Danish, Swedish or Norwegian to complete the study paperwork
Disqualifiers
Inability to give informed consent
Undisplaced shaft fracture (less than a cortex-wide displacement in all radiographic plane)
Vascular injury in ipsilateral arm
Polytrauma (defined as a trauma with one or more concurrent fractures to the upper extremities or other trauma absolute indications for surgical intervention)
Trial design
Design model
Parallel
Treatments tested in this trial
Surgical treatment
Procedure/SurgeryWe 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.
Non-surgical treatment
DeviceNon-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.
Treatment groups
287 Participants
are divided into 2 treatment groupsGroup A: Surgical TreatmentExperimental treatment 1 intervention
Group B: Non-surgical treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Disabilities of the Arm, Shoulder and Hand (DASH) score
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)
Time frame
52 weeksSecondary outcomes
1
EuroQol-5 Domain (EQ-5D-5L)
EuroQol questionnaire for patient reported outcome concerning health related quality of life measure. The score includes five dimensions with 5 levels from 1 (indicating no problem) to 5 (indicating extreme problem). EQ-5D-5L describes 3125 potential health states. A score of 11111 indicates having no problems in any of the dimensions and a score of 55555 indicates having extreme problems in all of the dimensions.
Time frame
Pre-Injury, 6 weeks, 12 weeks, 26 weeks, 52 weeks2
Rate of complications
Complications after treatment will be recorded and include local complications, early general complication and mortality: * Local complications: Infection (needing antibiotic treatment with or without debridement), nerve or vascular injury, surgical revision (due to implant malpositioning, hardware failure, aseptic loosening or peri-implant fracture) and tolerance problems with brace (discomfort resulting in non-compliance of wearing the brace * Early general complications needing hospitalization within 12 weeks: Major adverse cardiac events (MACE) including myocardial infarction, heart failure, thromboembolism, cardiomyopathy and cardiac arrythmias. Other major adverse events including pneumonia, renal failure, electrolyte abnormality and deficiency anemia and other unforeseen reasons for hospitalization. • Mortality
Time frame
Up to 52 weeks3
Visual Analogue Scale (VAS)
Visual analog scale is a pain score. Scores range from 0 (no pain) to 100 (worst pain).
Time frame
Baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks4
Anchor question
Anchor questions will include Clinical anchor questions (CAQ), Retrospective Global Transition questions (RGTQ) and Binary Repeat Treatment (BRT). RGTQ and BRT will only be obtained at 52 weeks.
Time frame
6 weeks, 12 weeks, 26 weeks, 52 weeksOther outcomes
1
Disabilities of the Arm, Shoulder and Hand (DASH) score
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)
Time frame
2 years, 5 years2
EuroQol-5 Domain (EQ-5D-5L)
EuroQol questionnaire for patient reported outcome concerning health related quality of life measure. The score includes five dimensions with 5 levels from 1 (indicating no problem) to 5 (indicating extreme problem). EQ-5D-5L describes 3125 potential health states. A score of 11111 indicates having no problems in any of the dimensions and a score of 55555 indicates having extreme problems in all of the dimensions.
Time frame
2 years, 5 years3
Radiological measurements
Radiographic images of the humeral shaft fracture will be assessed for fracture displacement, angulation, pattern, location and progression of radiological union.
Time frame
Baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks4
Fracture instability
Clinical sign of gross instability of the fracture site
Time frame
6 weeks, 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kolding Sygehus
Lead sponsor
Copenhagen University Hospital, Hvidovre
Collaborator
Zealand University Hospital
Collaborator
Oslo University Hospital
Collaborator
Helse Stavanger HF
Collaborator
Sahlgrenska University Hospital
Collaborator
Uppsala University Hospital
Collaborator
Odense University Hospital
Collaborator
Hospital of Southern Jutland
Collaborator
Slagelse Hospital
Collaborator
Aalborg University Hospital
Collaborator
University Hospital, Umeå
Collaborator
Nordsjaellands Hospital
Collaborator
Holbaek Sygehus
Collaborator
Aarhus University Hospital
Collaborator
Copenhagen University Hospital at Herlev
Collaborator
University Hospital Bispebjerg and Frederiksberg
Collaborator
Viborg Regional Hospital
Collaborator
Karolinska University Hospital
Collaborator
Danderyd Hospital
Collaborator
Tampere University Hospital
Collaborator
Helsinki University Central Hospital
Collaborator
Source ClinicalTrials.gov