Surgical vs Nonsurgical Treatment of Adults With Displaced Fractures of the Proximal Humerus
Authors: Amar Rangan, Helen Handoll, Stephen Brealey, Laura Jefferson, Ada Keding, Belen Corbacho Martin, Lorna Goodchild, Ling-Hsiang Chuang, Catherine Hewitt, David Torgerson
Journal: JAMA (2015)

<h3>Importance</h3> The need for surgery for the majority of patients with displaced proximal humeral fractures is unclear, but its use is increasing. <h3>Objective</h3> To evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck. <h3>Design, Setting, and Participants</h3> A pragmatic, multicenter, parallel-group, randomized clinical trial, the Proximal Fracture of the Humerus Evaluation by Randomization (PROFHER) trial, recruited 250 patients aged 16 years or older (mean age, 66 years [range, 24-92 years]; 192 [77%] were female; and 249 [99.6%] were white) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 within 3 weeks after sustaining a displaced fracture of the proximal humerus involving the surgical neck. Patients were followed up for 2 years (up to April 2013) and 215 had complete follow-up data. The data for 231 patients (114 in surgical group and 117 in nonsurgical group) were included in the primary analysis. <h3>Interventions</h3> Fracture fixation or humeral head replacement were performed by surgeons experienced in these techniques. Nonsurgical treatment was sling immobilization. Standardized outpatient and community-based rehabilitation was provided to both groups. <h3>Main Outcomes and Measures</h3> Primary outcome was the Oxford Shoulder Score (range, 0-48; higher scores indicate better outcomes) assessed during a 2-year period, with assessment and data collection at 6, 12, and 24 months. Sample size was based on a minimal clinically important difference of 5 points for the Oxford Shoulder Score. Secondary outcomes were the Short-Form 12 (SF-12), complications, subsequent therapy, and mortality. <h3>Results</h3> There was no significant mean treatment group difference in the Oxford Shoulder Score averaged over 2 years (39.07 points for the surgical group vs 38.32 points for the nonsurgical group; difference of 0.75 points [95% CI, −1.33 to 2.84 points];<i>P</i> = .48) or at individual time points. There were also no significant between-group differences over 2 years in the mean SF-12 physical component score (surgical group: 1.77 points higher [95% CI, −0.84 to 4.39 points];<i>P</i> = .18); the mean SF-12 mental component score (surgical group: 1.28 points lower [95% CI, −3.80 to 1.23 points];<i>P</i> = .32); complications related to surgery or shoulder fracture (30 patients in surgical group vs 23 patients in nonsurgical group;<i>P</i> = .28), requiring secondary surgery to the shoulder (11 patients in both groups), and increased or new shoulder-related therapy (7 patients vs 4 patients, respectively;<i>P</i> = .58); and mortality (9 patients vs 5 patients;<i>P</i> = .27). Ten medical complications (2 cardiovascular events, 2 respiratory events, 2 gastrointestinal events, and 4 others) occurred in the surgical group during the postoperative hospital stay. <h3>Conclusions and Relevance</h3> Among patients with displaced proximal humeral fractures involving the surgical neck, there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over 2 years following fracture occurrence. These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus. <h3>Trial Registration</h3> isrctn.com Identifier:ISRCTN50850043