title: Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus: the PROFHER randomized clinical trial.
abstract: OBJECTIVE
  The need for surgery for the majority of patients with displaced proximal humeral fractures is unclear, but its use is increasing.
  
  
  OBJECTIVE
  To evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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]; P = .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]; P = .18); the mean SF-12 mental component score (surgical group: 1.28 points lower [95% CI, -3.80 to 1.23 points]; P = .32); complications related to surgery or shoulder fracture (30 patients in surgical group vs 23 patients in nonsurgical group; P = .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; P = .58); and mortality (9 patients vs 5 patients; P = .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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  isrctn.com Identifier: ISRCTN50850043.
authors.affiliation: James Cook University Hospital, Middlesbrough, England.
authors.forename: Amar
authors.initials: A
authors.lastname: Rangan
authors.affiliation: Health and Social Care Institute, School of Health and Social Care, Teesside University, Middlesbrough, England.
authors.forename: Helen
authors.initials: H
authors.lastname: Handoll
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, England.
authors.forename: Stephen
authors.initials: S
authors.lastname: Brealey
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, England.
authors.forename: Laura
authors.initials: L
authors.lastname: Jefferson
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, England.
authors.forename: Ada
authors.initials: A
authors.lastname: Keding
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, England.
authors.forename: Belen Corbacho
authors.initials: BC
authors.lastname: Martin
authors.affiliation: James Cook University Hospital, Middlesbrough, England.
authors.forename: Lorna
authors.initials: L
authors.lastname: Goodchild
authors.affiliation: Pharmerit Europe, Rotterdam, the Netherlands.
authors.forename: Ling-Hsiang
authors.initials: LH
authors.lastname: Chuang
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, England.
authors.forename: Catherine
authors.initials: C
authors.lastname: Hewitt
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, England.
authors.forename: David
authors.initials: D
authors.lastname: Torgerson
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005592:Fracture Fixation / Q000379:methods*; D006801:Humans; D006811:Humerus / Q000293:injuries*; D007103:Immobilization; D008297:Male; D008875:Middle Aged; D009984:Orthopedic Fixation Devices; D011183:Postoperative Complications; D012784:Shoulder Fractures / Q000150:complications / Q000601:surgery* / Q000628:therapy*; D016896:Treatment Outcome