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Randomized Controlled Trial
. 2017 Mar;99-B(3):383-392.
doi: 10.1302/0301-620X.99B3.BJJ-2016-1028.

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

H H Handoll  1 , A Keding  2 , B Corbacho  2 , S D Brealey  2 , C Hewitt  2 , A Rangan  3
Affiliations
Randomized Controlled Trial

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

H H Handoll et al. Bone Joint J. 2017 Mar.

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.

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Figures

Fig. 1
Fig. 1
Participant flow diagram.
Fig. 2
Fig. 2
Unadjusted mean Oxford Shoulder Scores (OSS) by allocated treatment (patients with available OSS only). Errors bars represent 95% confidence intervals.
Figs. 3a - 3b
Figs. 3a - 3b
Unadjusted mean Oxford Shoulder Scores (OSS) by allocation and age group (patients with available OSS only): a) age < 65 years; b) age ≥ 65 years. Errors bars represent 95% confidence intervals.
Figs. 3a - 3b
Figs. 3a - 3b
Unadjusted mean Oxford Shoulder Scores (OSS) by allocation and age group (patients with available OSS only): a) age < 65 years; b) age ≥ 65 years. Errors bars represent 95% confidence intervals.
Figs. 4a - 4b
Figs. 4a - 4b
Unadjusted mean Oxford shoulder Scores (OSS) by allocation and tuberosity involvement group (patients with available OSS only): a) neither tuberosities involved; b) one or both tuberosities involved. Errors bars represent 95% confidence intervals.
Figs. 4a - 4b
Figs. 4a - 4b
Unadjusted mean Oxford shoulder Scores (OSS) by allocation and tuberosity involvement group (patients with available OSS only): a) neither tuberosities involved; b) one or both tuberosities involved. Errors bars represent 95% confidence intervals.
Fig. 5
Fig. 5
Mean EuroQol-5D-3L (EQ-5D-3L) scores at baseline and follow-up points to five years. Error bars represent 95% confidence intervals.
See this image and copyright information in PMC

References

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