Comparing surgical and non-surgical treatments for two-part proximal humerus fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of surgical versus conservative management for displaced two-part proximal humerus fractures in patients aged 60 to 85. Participants will be randomly assigned to receive either open reduction and internal fixation (ORIF) or non-operative treatment. The study will assess functional outcomes using the Quick DASH score and other evaluations at multiple follow-up points over a year. The trial is designed as a single-blinded randomized controlled trial conducted at Akershus University Hospital.

Why it matters

Who can join: the full rules

-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.

Where it's running

• Akershus University Hospital
  Lørenskog, Oslo, Norway Recruiting

Study contacts

• Study coordinator: Annette Konstanse Bordewich Wikerøy, MD
• Email: awikeroy@hotmail.com
• Phone: 004799717481

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.