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

Abstract

BackgroundProximal humeral fractures, which occur mainly in older adults, account for approximately 4 to 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 management. Currently there is much variation in the use of surgery and a lack of good quality evidence to inform this decision.Methods/DesignWe 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. The choice of surgical intervention is left to the surgeon, who 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 a minimum of 18 NHS trauma centres throughout the UK. These patients will be followed-up for 2 years. The primary outcome is the Oxford Shoulder Score, which will be collected via questionnaires completed by the trial participants at 6, 12 and 24 months. 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. Additionally, we plan a systematic collection of reasons for non-inclusion of eligible patients who were not recruited into the trial, and their baseline characteristics, treatment preferences and intended treatment.DiscussionThis article presents the protocol for a multi-centre randomised controlled trial. It gives extensive details of, and the basis for, the chosen methods, and describes the key measures taken to avoid bias and to ensure validity.Trial RegistrationCurrent Controlled Trials ISRCTN50850043

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

“…40 The choice of surgical intervention was the decision of the surgeons, who had to use techniques with which they were experienced and fully familiar. Good standards of non-surgical care, including care-provider competence, and a comparable provision of rehabilitation for both groups of patients were expected.…”

“…The final version of the study protocol (version 7), shown in Appendix 3, was published in 2009. 40 Appendix 4 summarises the changes to the protocol.…”

Two-Part Proximal Humerus Fractures: Whether to Plate or Nail?

“…2,3 Non-operative treatment is the gold standard for undisplaced proximal humerus fractures, with good outcomes. 4,5 Displaced fractures may be treated operatively using different fixation techniques which include percutaneous k-wire fixation, proximal humerus locking plate (LP) and screw fixation, intramedullary nailing (IMN), hemiarthroplasty with different success rates. 2 Open reduction and internal fixation (ORIF) and plate osteosynthesis and closed reduction with nailing are two common methods of fixing Neer 6 two-part proximal humerus fractures.…”

Cost effectiveness of surgical versus non-surgical treatment of adults with displaced fractures of the proximal humerus

“…Given the established lack of evidence to conclude whether surgical intervention produces consistently better outcomes than non-surgical treatment for these fractures 5 , the Proximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) trial was conducted to evaluate the clinical effectiveness and cost-effectiveness of surgery compared with nonsurgical treatment of the majority of displaced fractures of the proximal humerus involving the surgical neck in adults 6 .…”