Scandinavian Humeral Diaphyseal Fracture Trial
Recruiting now · Not applicable
Conditions studied: Fracture Humerus of Shaft
In brief
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.
Key facts
- Study ID
- NCT04574336
- Run by
- Kolding Sygehus
- People needed
- 287
- Starts
- 2022-04-04
- Expected to finish
- 2031-07-31
- Last updated by the study team
- 2024-04-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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)
- Pathological fracture
- Open fracture
- BMI > 40
- Health conditions preventing either treatment
Where it is running
- Aabenraa Hospital — Aabenraa, Denmark (enrolling)
- Aarhus Hospital — Aarhus, Denmark (enrolling)
- Bispebjerg Hospital — Copenhagen, Denmark (enrolling)
- Hvidovre Hospital — Copenhagen, Denmark (enrolling)
- Esbjerg Hospital — Esbjerg, Denmark (enrolling)
- Aalborg-Farsø Hospital — Farsø, Denmark (enrolling)
- Herlev-Gentofte Hospital — Gentofte Municipality, Denmark (enrolling)
- New North Zealand Hospital — Hillerød, Denmark (enrolling)
- Holbæk Hospital — Holbæk, Denmark (enrolling)
- Kolding Hospital — Kolding, Denmark (enrolling)
- Zealand University — Køge, Denmark (enrolling)
- Odense Hospital — Odense, Denmark (enrolling)
- Slagelse Hospital — Slagelse, Denmark (enrolling)
- Viborg Regional Hospital — Viborg, Denmark (enrolling)
- Helsinki University Hospital — Helsinki, Finland (enrolling)
- Tampere University Hospital — Tampere, Finland (enrolling)
- Oslo University Hospital (Ullevål) — Oslo, Norway (enrolling)
- Stanvanger University Hospital — Stavanger, Norway (enrolling)
- Danderyd University Hospital — Stockholm, Sweden (enrolling)
- Karolinska University Hospital — Stockholm, Sweden (enrolling)
- Umeå University Hospital — Umeå, Sweden (enrolling)
- Uppsala University Hospital — Uppsala, Sweden (enrolling)
Full record on ClinicalTrials.gov
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