Details of HTA project in progress
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Primary Research (e.g. trial) |
Project title: |
Pragmatic multi-centre randomised trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults |
 Outputs in journals arising from this project
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Project ref: |
06/404/53 |
Cost: |
£1,485,585 |
Chief Investigator : |
Professor Amar Rangan, Consultant Orthopaedic Surgeon, Department of Trauma and Orthopaedics, South Tees Hospitals NHS Trust/University of Teesside |
Project Website |
http://www.profher.org/ |
Start Date: |
March 2008 |
Estimated date of publication in HTA journal series: |
Mid 2015. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
Fracture of the proximal humerus (the top part of the upper arm bone) is common, particularly in older adults. Generally, less serious fractures are successfully treated by supporting the injured arm in a sling until the fracture mends. However, for more serious fractures, where two or more bony fragments are displaced, there is little evidence to clarify whether surgery or non-surgical treatment is best. Researchers from the Universities of Teesside and York will conduct a randomised controlled trial involving approximately 18 NHS trauma centres to compare surgery with non-surgical treatment for the more common types of displaced fracture. Surgery for less complex fracture patterns involves realigning the fracture fragments and fixing them with wires, nails or plates. In more complex fractures, the humeral head is sometimes replaced by an artificial joint. The research team will measure how much shoulder function patients have after treatment, by gathering questionnaire data at 6, 12 and 24 months. We will also collect data for other outcomes including general health measures, complications and treatment costs. The trial findings will be available in 2013 |
Project Abstract: |
Proximal humeral fractures, which occur mainly in older adults, account for approximately 4-5% of all fractures. Approximately 40% of these fractures are displaced fractures involving the surgical neck. Management of this group of fractures is often challenging and the outcome is frequently unsatisfactory. In particular it is not clear whether surgery gives better outcomes than non-surgical treatment. Currently there is much variation in the use of surgery as well as a lack of good quality evidence to inform this decision. We aim to undertake a pragmatic UK-based multi-centre randomised controlled trial evaluating the effectiveness and cost-effectiveness of surgical versus standard non-surgical treatment for adults with an acute closed displaced fracture of the proximal humerus with involvement of the surgical neck. Only those people for whom a participating surgeon would consider surgical treatment will be included. The choice of surgical methods is left to the surgeon, the only requirement being that they must use techniques that they are fully experienced with. This will avoid 'learning curve' problems. We will promote good standards of non-surgical care, similarly insisting on care-provider competence, and emphasize the need for comparable provision of rehabilitation for both groups of patients. We aim to recruit 250 patients from approximately 18 NHS trauma centres throughout the UK. These patients will be followed-up for 2 years. The primary outcome, collected via questionnaires completed by the trial participants at 6, 12 and 24 months, is the Oxford Shoulder Score. This is a 12-item condition-specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment. We will also collect data for other outcomes including general health measures and complications, and for an economic evaluation. The trial is run by the Universities of Teesside and York. |
ISRCTN* number: | ISRCTN 50850043 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN50850043 |
Project Protocol: |
Project protocol (pdf format, 157 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1660 |
Outputs from this project
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