PROximal Fractures of the Humerus: Evaluation by Randomisation

The ProFHER trial is a pragmatic multi-centre randomised controlled trial that aims to evaluate the effectiveness and cost-effectiveness of surgical versus non-surgical treatment for the majority of displaced fractures of the proximal humerus in adults. It is funded by the Department of Health’s Health Technology Assessment Programme. It is a joint collaboration between the University of Teesside (trial sponsor) and University of York. Trial management is by the York Trials Unit.

 

Background

Proximal humeral fractures account for approximately 4-5% of all fractures. Their incidence rapidly increases with age (mean age ~ 70 years), and women are affected over twice as often as men.  Around half of these fractures are displaced and around 40% involve displacement of the surgical neck. Similar to other primarily osteoporotic fractures, the incidence of these fractures is increasing.

Figure 1 shows (A) an example of a Valgus impacted fracture; and (B) treatment of the fracture with plate fixation.

There is large variation in practice in the treatment of these fractures, which often have an unsatisfactory outcome. In particular, there is a lack of reliable evidence to inform the question of whether displaced (surgical neck) fractures should be treated surgically. These and the growing professional recognition of need for evidence on this issue have provided the motivation and rationale for this trial.

 

Aim of trial

The ProFHER trial group aims to evaluate the effectiveness and cost-effectiveness of surgical versus standard non-surgical treatment for the majority of displaced fractures of the proximal humerus in adults

 

Recruitment of patients

We aim to recruit 250 patients from around 20 NHS trauma centres in the UK. Patients will be approached to take part by an orthopaedic surgeon who will assess their eligibility. Patients will be eligible if they are aged 16 or above, presenting within three weeks of their injury with a radiologically confirmed displaced fracture of the proximal humerus with involvement of the surgical neck that the surgeon would consider treating surgically. Those who consent to take part will then be randomised to surgery or no surgery.

Because this is a pragmatic trial, the choice of surgery is left to the surgeon with one condition that the surgeon uses a technique with which they are familiar. This avoids ‘learning curve’ problems. Another key requirement is that good quality conservative care is provided together with comparable rehabilitation, including access to physiotherapy, for both treatment groups. Both these requirements are needed in order to answer the question reliably.

 

Outcome measurement

·         Primary outcome: Oxford Shoulder Score

·         Secondary outcomes: SF-12; EQ-5D; surgical and early medical complications, referrals for secondary treatment, mortality

·         Economic: Hospital cost data; EQ-5D; patient-reported use of healthcare

 

Follow-up for patient questionnaires: 3, 6, 12 and 24 months.

 

Timeline 

April 2008

Start of funding

October 2009

Start of trial recruitment (18 month

March 2010

End of recruitment

March 2011

End of 1 year follow-up

March 2012

End of 2 year follow-up

September 2012

Complete project

 

Contact details

Mr Amar Rangan (Chief Investigator) or Dr Stephen Brealey (Trial Co-ordinator) would be happy to discuss the trial and provide further information during the BESS meeting.

 

After the BESS meeting, please contact for further information Dr Stephen Brealey on 01904 321357 or email sb143@york.ac.uk or Prof Amar Rangan on 01642 854380 or email amar.rangan@stees.nhs.uk

 

PROximal Fracture of Humerus: Evaluation by Randomisation (PROFHER) Trial

A multi-centre randomised controlled trial funded by NHS R&D Health Technology Assessment Programme

(International Standardised Randomised Controlled Trial Number 50850043)

 

 

 

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