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The proximal humerus fracture (PHFs) is the third most common fracture type in the elderly, and represents 5% of the overall fractures. The incidence is increasing. The purpose of the project is to compare surgical and conservative management of two- part PHFs in light of radiological, economical and clinical outcome. Do the participants between 60 and 85 years of age with displaced two-part PHFs fare better or worse after surgery compared to non-operative treatment?
Full description
The study-design is a single center single blinded randomized controlled trial (RCT) with 2 arms. Patients admitted to Akershus University Hospital (Ahus) with a displaced two-part proximal humeral fracture of OTA/ AO group 11A2 or 11A3 in need of surgical treatment will be randomly allocated to two groups; conservative/ non-operative treatment or open reduction and internal fixation (ORIF).
All following aims evaluated at controls at 6, 12, 26 and 52 weeks. The 6 months and 1 year controls will additionally be conducted by independent physiotherapists. The other controls are conducted by the treating surgeons. The physiotherapists will be blinded of chosen treatment, the patients wearing a t-shirt covering the shoulder at the consultations, hence single blinded RCT.
Primary aim: Functional outcome as evaluated by the Quick DASH (Disability of the arm, shoulder and hand) score at controls.
Preoperative evaluation:
The project participants will supervise and evaluate the data. General history, including; mechanism of injury, occupation, pre-existing medical conditions and medication, smoking history, American Society of Anesthesiologists Classification (ASA classification), BMI, hand dominance. At inclusion, the patient will be asked to fill out quick-Dash, Visual Analog scale (VAS), EQ-5D to determine the baseline-characteristics.
Postoperative evaluation:
Evaluation of postoperative radiographs for reduction of fracture and possible errors of the operative technique by the project participants and a radiologist.
Secondary aims:
In the literature, the following risk factors for failure of the osteosynthesis, Avascular necrosis (AVN) or chance of poor functional outcome are outlined; the factors will be examined as subgroups to see whether they are representative also for our population:
Patients allocated to the conservative group may be offered surgical treatment if the fracture changes/ dislocates, in example no contact between the fracture ends if the patients activities of daily living (ADL) is greatly affected or pain is disproportionately
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Inclusion and exclusion criteria
-The study-design is a single center single blinded randomized controlled trial (RCT) with 3 arms. Patients admitted to Akershus University Hospital with a displaced 2-part proximal humeral fracture of OTA/ AO group 11A2 or 11A3 in need of surgical treatment will be randomly allocated to two groups; conservative/ non-operative treatment or open reduction and internal fixation (ORIF). The patients allocated to ORIF will be randomly allocated to either the Philos plate (Synthes) or the Multiloc nail (Synthes).
Inclusion criteria
Exclusion Criteria:
Primary purpose
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Interventional model
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50 participants in 2 patient groups
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Central trial contact
Hendrik Fuglesang, MD, PhD; Annette Konstanse Bordewich Wikerøy, MD
Data sourced from clinicaltrials.gov
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