Two- Part Proximal Humerus - Conservative vs Operative

Launched by UNIVERSITY HOSPITAL, AKERSHUS · Sep 26, 2019

Keywords

ClinConnect Summary

This clinical trial is looking to find out whether older adults aged 60 to 85 with a specific type of shoulder fracture, called a two-part proximal humerus fracture, recover better with surgery or without it. The study will compare two treatment options: one group will receive conservative care, which means they won't have surgery and will be treated with rest and physical therapy, while the other group will undergo surgery to fix the fracture using different methods. Researchers want to understand how these two approaches affect patients’ recovery based on medical imaging, costs, and overall health outcomes.

To participate, patients need to have a certain type of fracture that is displaced, meaning the bone has moved out of its normal position, and they must be within the age range specified. Some patients may not be eligible if they have other serious health conditions or if the fracture is too old. Those who join the study will be randomly assigned to one of the two treatment groups and will receive care at Akershus University Hospital. This trial aims to help determine the best way to treat this common injury and improve recovery for older adults.

Gender

ALL

Eligibility 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
• • 1. Patients \> 60 years and \<85 years
• • 2. 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).
• • 3. 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.