Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial

PLoS Med. 2019 Jul 18;16(7):e1002855. doi: 10.1371/journal.pmed.1002855. eCollection 2019 Jul.

Abstract

Background: Although increasingly used, the benefit of surgical treatment of displaced 2-part proximal humerus fractures has not been proven. This trial evaluates the clinical effectiveness of surgery with locking plate compared with non-operative treatment for these fractures.

Methods and findings: The NITEP group conducted a superiority, assessor-blinded, multicenter randomized trial in 6 hospitals in Finland, Estonia, Sweden, and Denmark. Eighty-eight patients aged 60 years or older with displaced (more than 1 cm or 45 degrees) 2-part surgical or anatomical neck proximal humerus fracture were randomly assigned in a 1:1 ratio to undergo either operative treatment with a locking plate or non-operative treatment. The mean age of patients was 72 years in the non-operative group and 73 years in the operative group, with a female sex distribution of 95% and 87%, respectively. Patients were recruited between February 2011 and April 2016. The primary outcome measure was Disabilities of Arm, Shoulder, and Hand (DASH) score at 2-year follow-up. Secondary outcomes included Constant-Murley score, the visual analogue scale for pain, the quality of life questionnaire 15D, EuroQol Group's 5-dimension self-reported questionnaire EQ-5D, the Oxford Shoulder Score, and complications. The mean DASH score (0 best, 100 worst) at 2 years was 18.5 points for the operative treatment group and 17.4 points for the non-operative group (mean difference 1.1 [95% CI -7.8 to 9.4], p = 0.81). At 2 years, there were no statistically or clinically significant between-group differences in any of the outcome measures. All 3 complications resulting in secondary surgery occurred in the operative group. The lack of blinding in patient-reported outcome assessment is a limitation of the study. Our assessor physiotherapists were, however, blinded.

Conclusions: This trial found no significant difference in clinical outcomes at 2 years between surgery and non-operative treatment in patients 60 years of age or older with displaced 2-part fractures of the proximal humerus. These results suggest that the current practice of performing surgery on the majority of displaced proximal 2-part fractures of the humerus in older adults may not be beneficial.

Trial registration: ClinicalTrials.gov NCT01246167.

Publication types

  • Comparative Study
  • Equivalence Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Bone Plates
  • Europe
  • Female
  • Fracture Fixation / adverse effects
  • Fracture Fixation / instrumentation
  • Fracture Fixation / methods*
  • Fracture Fixation, Internal* / adverse effects
  • Fracture Fixation, Internal* / instrumentation
  • Fracture Healing*
  • Humans
  • Male
  • Middle Aged
  • Orthotic Devices
  • Pain, Postoperative / etiology
  • Physical Therapy Modalities* / adverse effects
  • Quality of Life
  • Recovery of Function
  • Shoulder Fractures / diagnostic imaging
  • Shoulder Fractures / physiopathology
  • Shoulder Fractures / therapy*
  • Time Factors
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01246167

Grant support

This research study received a grant from the Academy of Finland (www.aka.fi; ref 275481, ML) for the Finland branch of the consortium and the overall maintenance of the trial. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.