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