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.
BACKGROUND
Proximal 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
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. 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.


CONCLUSIONS
This 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.


BACKGROUND
Current Controlled Trials ISRCTN50850043.
Handoll
Helen
H
Centre for Rehabilitation Sciences, Health Sciences and Social Care Institute, Teesside University, Middlesbrough, Tees Valley TS1 3BA, UK. h.handoll@tees.ac.uk
Brealey
Stephen
S
Rangan
Amar
A
Torgerson
David
D
Dennis
Laura
L
Armstrong
Alison
A
Chuang
Ling-Hsiang
LH
Cross
Ben
B
Dumville
Jo
J
Gardner
Sarah
S
Goodchild
Lorna
L
Hamilton
Sharon
S
Hewitt
Catherine
C
Madhok
Rajan
R
Maffulli
Nicola
N
Micklewright
Lucy
L
Wadsworth
Valerie
V
Wallace
Angus
A
Williams
John
J
Worthy
Gill
G
D000203:Activities of Daily Living; D000328:Adult; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D005593:Fracture Fixation, Internal / Q000009:adverse effects / Q000191:economics; D017048:Health Care Costs; D006801:Humans; D010147:Pain Measurement; D011482:Protective Devices; D012107:Research Design; D012149:Restraint, Physical / Q000009:adverse effects / Q000295:instrumentation; D012784:Shoulder Fractures / Q000150:complications / Q000175:diagnosis / Q000191:economics / Q000601:surgery / Q000628:therapy*; D020069:Shoulder Pain / Q000209:etiology; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom