Two- Part Proximal Humerus - Conservative vs Operative
Conservative Versus Operative Treatment of Two - Part Proximal Humerus Fractures
University Hospital, Akershus
50 participants
Oct 1, 2020
INTERVENTIONAL
Conditions
Summary
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?
Eligibility
Inclusion Criteria4
- 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).
- Patients > 60 years and <85 years
- More than 50% displacement between head or shaft or 50⁰ angulation of the head against the shaft in Y-projection or more than 45 ˚ valgus or more than 30˚ varus of the Head Shaft Angle (HSA).
- Patient with tuberculum majus or minor fractures which displaced <5mm can be included as long as points 1 and 2 above are fulfilled.
Exclusion Criteria19
- Refusal to participate in the study
- Fracture more than 3 weeks old
- No contact btw head and shaft
- Ipsilateral damage that will influence the recovery and scoring systems
- Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity. This is up to the treating surgeon to decide
- Pathological fracture or previous fracture of the same proximal humerus
- Multitrauma or "multifractured patient"
- Neurovascular injury
- Open fracture
- Noncompliance, dementia and/ or institutionalized
- Congenital anomaly
- Ongoing infectious process around the incision site for osteosynthesis
- Systemic disease that may influence healing processes or scoring systems (in example Rheumatoid arthritis/Multiple sclerosis/ poorly controlled DM)
- Fracture dislocation
- Substance abuse
- Inability to read and understand Norwegian
- Patients not residing in our catchment area
- Patients with a diameter of the humerus to small for nailing, will be allocated to the Philos-group.
- Any medical condition that excludes surgical treatment, including patients with ASA 3 or 4 that are considered too ill to go through surgery.
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Interventions
Treatment allocated to surgical or non-surgical group. Implant choice pragmatic, surgeons choice.
Locations(1)
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NCT04106674