Five-year follow-up results of the PROFHER trial comparing operative and non-operative treatment of adults with a displaced fracture of the proximal humerus

Bone Joint J. 2017 Mar;99-B(3):383-392. doi: 10.1302/0301-620X.99B3.BJJ-2016-1028.

Abstract

Aims: The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non-operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long-term treatment effects beyond the two-year follow-up.

Patients and methods: Of the original 250 trial participants, 176 consented to extended follow-up and were sent postal questionnaires at three, four and five years after recruitment to the trial. The Oxford Shoulder Score (OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent shoulder operations and fracture data were collected. Statistical and economic analyses, consistent with those of the main trial were applied.

Results: OSS data were available for 164, 155 and 149 participants at three, four and five years, respectively. There were no statistically or clinically significant differences between operative and non-operative treatment at each follow-up point. No participant had secondary shoulder surgery for a new complication. Analyses of EQ-5D-3L data showed no significant between-group differences in quality of life over time.

Conclusion: These results confirm that the main findings of the PROFHER trial over two years are unchanged at five years. Cite this article: Bone Joint J 2017;99-B:383-92.

Keywords: Long-term follow-up; Operative versus non-operative treatment; Proximal humeral fractures; Randomised controlled trial.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Female
  • Follow-Up Studies
  • Fracture Fixation / methods*
  • Humans
  • Male
  • Middle Aged
  • Quality of Life
  • Recovery of Function
  • Shoulder Fractures / surgery
  • Shoulder Fractures / therapy*
  • Shoulder Joint / physiopathology
  • Treatment Outcome
  • Young Adult