Study rationale
Conservative treatment, plate fixation, or prosthesis for proximal humeral fracture. A prospective randomized study was a multicenter, prospective, randomized controlled trial conducted in Finland, Estonia, Sweden, and Denmark . The study aimd to evaluate the optimal treatment approach for displaced proximal humerus fractures in patients aged 60 years and older. Given the increasing incidence of fractures, particularly among older patients due to low-energy trauma like falls, determining the most effective treatment method is crucial for patient outcomes and healthcare resource allocation.
Proximal humerus fractures are the third most common fracture type in the elderly, following hip and distal radius fractures. Despite their prevalence, there is a lack of high-quality evidence guiding treatment decisions. Traditionally, approximately 85% of these fractures are managed non-operatively, with patients often regaining satisfactory shoulder function. However, the increasing use of surgical interventions, such as locking plate fixation and hemiarthroplasty, necessitates thoroughly comparing these methods against non-operative treatment.
Study design
The study was structured into two strata based on fracture complexity. Stratum I included patients with two-part fractures, comparing outcomes between non-operative treatment and operative fixation using locking plates. Stratum II encompassed patients with more complex three- and four-part fractures, comparing non-operative treatment, locking plate fixation, and hemiarthroplasty.
The primary outcome measure was the Disabilities of the Arm, Shoulder and Hand (DASH) score, assessing upper limb function. Secondary outcomes included the EuroQol-5D (EQ-5D) for health-related quality of life, the Oxford Shoulder Score (OSS), the Constant-Murley Score for shoulder function, the Visual Analogue Scale (VAS) for pain, and the 15D instrument for overall health status. These comprehensive outcome measures aimed to capture both functional and quality-of-life aspects of each treatment modality.
Status
The trial recruited participants over a seven-year period, with a two-year follow-up for outcome assessment. The trial has concluded and two publications, from both Stratum has been published.
