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