The ProFHER Trial found no important differences in shoulder function between surgery compared to non-surgical treatment for patients who fractured the top of their humerus. Surgery was more expensive than arm support with a sling.
Fracture of the proximal humerus (the top part of the upper arm bone) is common, particularly in older adults. There are two ways to treat these fractures: supporting the injured arm in a sling or surgery to put the fracture fragments back in place and fixing them with plates, screws, or an artificial joint. There was a need to clarify whether surgical or non-surgical treatment is best for these types of fractures.
We conducted a randomised controlled trial, with 250 patients. Half of the patients received surgery and half received support in a sling.
All these patients were followed up at 6, 12, and 24 months after randomisation to find out about their shoulder function, quality of life, and general health.
We worked with 35 NHS hospitals in the UK who could provide both surgical and non-surgical care for these patients.
We found that there were no important differences in shoulder function, general health, complications, or treatment for complications between patients in the surgery group and those in the non-surgery group. However, we found that surgery costs more than supporting the injured arm in a sling.
A subsequent survey of 265 orthopaedic surgeons who treat these fractures found that around half of them had changed practice due to the trial results and around one-third were already using a sling so did not need to change.
Two questions remained once the ProFHER trial was finished:
Both questions are being answered by the ProFHER-2 Trial, which is currently ongoing.
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The research was commissioned by NIHR HTA programme (Award ID: 06/404/53) and a grant of £1,325,959.60 awarded. The project was started in April 2008 and completed in July 2016.
Department of Health Sciences, University of York, York, UK
Helen Handoll
Health and Social Care Institute, School of Health and Social Care, Teesside University, Middlesbrough, UK
Amar Rangan
Department of Trauma and Orthopaedics, James Cook University Hospital, Middlesbrough, UK
Ling-Hsiang Chuang
Pharmerit Europe, Rotterdam, the Netherlands
Lorna Goodchild
Department of Rehabilitation, James Cook University Hospital, Middlesbrough, UK