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.
- Proximal humeral fractures
- Randomised controlled trial
- Operative versus non-operative treatment
- Long-term follow-up
H. Handoll: Advised on and contributed to methods and reporting throughout the trial, Wrote the first and revised drafts of the paper incorporating separate reports from AK and BC.
A. Keding: Trial statistician, Provided advice on methods, Produced and implemented statistical analysis plan, Contributed to the preparation of the paper.
B. Corbacho: Trial health economist, Produced the health economics analysis plan, Conducted the economics analysis, Contributed to the preparation of the paper.
S. Brealey: Trial manager, Advised on the design and coordinated the implementation of the extended follow-up including data collection, Contributed to the writing.
C. Hewitt: Statistician, Independently repeated primary analysis, Commented on paper.
A. Rangan: Chief investigator, Advised on the study design and on the clinical aspects of the analysis, Contributed to the writing.
We are grateful to the patients who generously completed questionnaires for the extended follow-up.
We thank R. Clarkson and L. Kottam (both at James Cook University Hospital, Middlesbrough, United Kingdom) for checking the Summary Care Records of patients for mortality, and staff at various participating sites for their help in locating missing patients.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (Project number: 06/404/53).
This paper presents independent research commissioned by the NIHR. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the UK National Institute for Health Research, the UK National Health Service, or the UK Department of Health.
The sponsor (Teesside University) managed the grant application process and monitored the study but it had no direct role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Although none of the authors has received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article, benefits have been or will be received but will be directed solely to a research fund, foundation, educational institution, or other non- profit organization with which one or more of the authors are associated.
This is an open-access article distributed under the terms of the Creative Commons Attributions licence (CC-BY-NC), which permits unrestricted use, distribution, and reproduction in any medium, but not for commercial gain, provided the original author and source are credited.
This article was primary edited by G. Scott and first proof edited by A. C. Ross.
- Received October 15, 2016.
- Accepted November 28, 2016.
- ©2017 Handoll et al