Stopped: Recruitment decline and research question getting outdated
Fractures of the proximal humerus are common in elderly patients. The optimal treatment of comminuted, displaced fractures is subject to controversy, and the results of operative treatment have not been shown to be superior to conservative treatment. The aim of the study is to compare locking plate osteosynthesis versus treatment with fracture hemiarthroplasty versus conservative treatment in a randomised, controlled protocol. The results of treatment are measured at 6 weeks, 3 months, 6 months, 12 months and 24 months. Main outcome measures are Pain at rest and activity (NRSs) and functional assessment of the shoulder with Constant Score. Secondary outcome measures are Simple Shoulder test (SST), Disabilities of the Arm, Shoulder and Hand (DASH), quality of life assessment (15D), subjective patient satisfaction and costs. The study also has a cohort follow-up of the patiens who decline randomisation. The recruitment target was 90 patients, but the study recruitment was stopped due to slow recruitment (too few patients presenting with eligibile injury to the hospital) at 60 patients in November 2019.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Pain at rest Numeric Rating Scale 0-10 (NRS)
Timeframe: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Pain in active motion NRS
Timeframe: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Constant Score
Timeframe: 3 mo, 6 mo, 1 year, 2 years