Proximal Fracture of the Humerus: Evaluation by Randomisation (ProFHER)
Fractures of the proximal humerus (the top part of the upper arm bone) are very common, particularly in older adults who have weaker bones (osteoporotic).
The treatment for this type of fracture can vary, depending on several factors. Some fractures can be successfully treated by supporting the injured arm in a sling until the fracture mends (immobilisation). Whilst other fractures can be treated by surgery, usually in cases where the bone has broken in two or more pieces which are out of alignment (displaced).
Despite this little is known about whether surgical or non-surgical treatment is best for the more common types of displaced fracture.
What we did
The aim of this study was to investigate the effectiveness and cost-effectiveness of surgical and non-surgical treatments for 250 patients with displaced fractures of proximal humerus.
Using the Neer classification, we identified:
1. 18 patients with one-part fractures.
2. 128 patients with two-part fractures.
3. 104 patients with three or four-part fractures.
What we found
Mean age of the 250 patients was 66 years and 77% were female.
Oxford Shoulder Scores (OSS) were available for 215 patients at 2 years. There was no statistically or clinically significant differences in scores between the two treatment groups over the 2-year period or at individual time points.
There was no statistically significant difference between surgical and non-surgical group participants in:
1. SF-12 physical or mental component summary scores.
2. Surgical or shoulder fracture-related complications.
3. Those undergoing further shoulder-related therapy, either surgery or other therapy.
The cost of surgical intervention was, on average, £1780.73 more per patient than the cost of non-surgical intervention.
Professor Amar Rangan
South Tees Hospitals NHS Foundation Trust
NIHR Health Technology Assessment (HTA) Programme
Cost-effective clinical trial design: Application of a Bayesian sequential model to the ProFHER pragmatic trial
Forster, et al (2021)
Concerns about the evidence in relation to implementation of the ProFHER trial
Handoll, et al. (2020)
BMJ Quality Safety
Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures
Handoll, et al. (2016)
Bone and Joint Research
“Away Days” in multicenter randomized controlled trials: a questionnaire survey of their use and a case study on the effect of one Away Day on patient recruitment
Jefferson, et al. (2016)
Journal of Evidence-Based Medicine
Cost effectiveness of surgical versus non-surgical treatment of adults with displaced fractures of the proximal humerus: economic evaluation alongside the PROFHER trial
Corbacho, et al. (2016)
Bone and Joint Journal
The ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial – a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults
Handoll, et al. (2015)
Health Technology Assessment
Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial: experiences from the ProFHER trial
Handoll, et al. (2014)
Bone and Joint Research
Protocol for the ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial: a pragmatic multi-centre randomised controlled trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults
Handoll, et al. (2009)
BMC Musculoskeletal Disorder