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UK’s first nationwide clinical trial on shoulder fractures reveals no significant difference between surgery and non-surgery

A five year study to determine the best treatment for a broken shoulder – surgery versus no surgery - could lead to significant financial savings.

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Together with researchers from Teesside University and the University of York, Professor Amar Rangan, clinical professor in trauma and orthopaedic surgery at The James Cook University Hospital, secured over £1.25m funding from the National Institute for Health Research’s Health Technology Assessment Programme in 2008 to lead the largest randomised clinical trial (ProFHER) to date on proximal humerus (shoulder) fractures.

The results have been published in the prestigious international Journal of the American Medical Association, (JAMA), and could lead to considerable cost savings for the NHS as the researchers found no significant difference between having surgery – which is being increasingly used - for the more serious types of proximal humerus fracture (broken shoulder) compared with non-surgical treatment.

The current treatment for this increasingly common injury, in people aged over 65, involves either putting the arm in a sling or surgery for the more serious fracture, but clinicians were unsure which treatment had the best outcome.

Professor Rangan, the chief investigator on the five-year project in collaboration with clinicians from 32 NHS hospitals across the country, recruited 250 patients into the trial. The patients, who were randomly allocated to surgery or no surgery through a service provided by the York Trials Unit, were followed up for two years with data collected at six, 12 and 24 months.

Patients recorded and ‘scored’ their own progress and experiences after treatment on a specially compiled questionnaire. The trial was managed by York Trials Unit, University of York, and The School of Health & Social Care at Teesside University was the trial sponsor.

In total the data for 231 patients – 114 in the surgical group and 117 in the non-surgical group – were included in the primary analysis.

This showed that there was no significant difference in self-assessed function and pain between those patients who were allocated surgery and those who were allocated not surgery. Other data showed no clinically or significant differences on measures of health-related quality of life, complications related to surgery or shoulder fracture, later surgery or treatment for these complications, and death.

Professor Rangan said: 'A broken or fractured shoulder can be a particularly painful injury and the function of the arm and shoulder can be considerably compromised - people don’t necessarily regain the independence they had before the injury.

'Some of these fractures clearly need surgery but for the majority it was not clear whether surgery was better than treating the injured arm in a sling followed by physiotherapy.

'Essentially this study was designed to find out whether one treatment was better than the other by evaluating the effectiveness and cost effectiveness of surgical versus non-surgical treatment.

'We know the use of surgery is increasing, but our trial has actually shown no significant difference between the two types of treatment which means we now have the potential to change future clinical treatment of this condition considerably.

'Also to have our paper accepted by JAMA – the Journal of the American Medical Association – is a real accolade.'

Dr Helen Handoll, Senior Lecturer and Research Fellow in Teesside University’s School of Health & Social Care Institute, added: 'This important trial, which has involved a huge team effort over several years, has produced reliable evidence to guide treatment on this common and serious injury.

'Crucially, it will help to reassure patients with these injuries that in most cases they would not do any better if they had surgery. Having such powerful evidence available for this condition is exceptional and it has the potential to change clinical treatment considerably.'

The team intend to publish a separate paper on cost-effectiveness shortly.

10 March 2015

In the News

Injury hopes for NHS cash
Evening Gazette, 11/03/2015; Gazette Live online, 10/03/2015
Trials sponsored by the School of Health and Social Care at Teesside University determine the best treatment for a broken shoulder.