Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-65
SponsorZealand University Hospital
About this trial
The goal of this clinical trial is to study whether surgery results in better functional outcomes than non-surgical treatment among patients aged 50-65 with a displaced proximal humerus fracture.
The main questions it aims to answer are:
• Does osteosynthesis result in better patient-reported functional outcomes compared to non-surgical treatment at 12 months follow-up?
Aim is also to characterize the patient group aged 50-65 regarding fracture morphology, osteoporosis, and clinical frailty scale.
The study compare operation with either plate or nail fixation to non-surgical treatment.
Participants will:
* Receive either surgical treatment or non-surgical treatment. * At 6 months, 1 year, and 2 years, the patient will answer two short questionnaires (Oxford Shoulder Score and Eq-5D-3L).
The primary outcome will be Oxford Shoulder Score at 12 months. The secondary outcome will be OSS at 6 and 24 months and EQ-5D-3L score measured at the same time-points. Adverse events and conversion to surgery will be registered. OSS and EQ-5D-3L will be completed just before the 6 months visit.
Eligibility criteria
Qualifiers
Patients aged between 50 and 65 years with a displaced PHF assessed to be constructible by the treating surgeon after a low-energy trauma will be considered for eligibility.
Patients should be cognitively capable of answering the follow-up questionnaires.
Disqualifiers
The patient does not understand written and spoken native language (Danish or Finnish/Swedish)
Inability to give informed consent
Fractures assessed to be unreconstructedly by the treating surgeon
Isolated tuberosity fracture, fracture dislocations, open fractures, and fractures with involvement of the articular surface
Trial design
Treatments tested in this trial
- Surgical
- Non surgical
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Zealand University Hospital
Lead sponsor
Tampere University Hospital
Collaborator
Source ClinicalTrials.gov