Status:
RECRUITING
Two- Part Proximal Humerus - Conservative vs Operative
Lead Sponsor:
University Hospital, Akershus
Conditions:
Proximal Humerus Fracture
2 Part Fracture
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief 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 co...
Detailed 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 fr...
Eligibility Criteria
Inclusion
- 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
- 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 Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2034
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04106674
Start Date
October 1 2020
End Date
October 31 2034
Last Update
October 25 2022
Active Locations (1)
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1
Akershus University Hospital
Lørenskog, Oslo County, Norway, 0587