The Nordic DeltaCon Trial is a prospective, single-blinded, randomized, controlled, multi-center and multi-national trial comparing reverse prosthesis and non-operative treatment in displaced proximal humerus fractures, in the elderly patients aged 65 to 85 years with displaced OTA/AO group B2 or C2 fractures (According to the new 2018 revision: AO/OTA (Orthopaedic Trauma Association) group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.1. )
Who can participate
Age range65 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Low energy AO/OTA group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.1. Both B and C type includes subgroups: Displaced \[2\], Impacted \[3\] or Non impacted \[4\] from the universal modifiers list.
Exclusion Criteria:
Radiographic Mal-inclination Less than; varus 30°or valgus 45° Less than 50% contact between head fragment and meta-/diaphysis Head split fractures with more than 10% of the articular surface in the main head fragment.
Head split fractures (group 11-C3.2 and 11-C3.3) with more than 10% of the articular surface in the main head fragment.
Dislocation or fracture-dislocation of the gleno-humeral joint Pathological fracture
General
* Refuse to participate
* Age under 65 years of age, or over 85 years of age
* Serious poly-trauma or additional surgery
* Non-independent, drug/alcohol abuse or institutionalized (low co-operation)
* Contra-indications for surgery
* Does not understand written and spoken guidance in local languages
* Previous fracture with symptomatic sequelae in either shoulder
* Patients living outside the hospital's catchment area
What they're measuring
1
Quick-DASH
Timeframe: From enrollment to 5 years follow-up. Scale 1-4 points (Total point x answers given) x25. Lowest point best