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

Hdl Handle:
http://hdl.handle.net/10149/95689
Title:
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
Authors:
Handoll, H. H. G. (Helen); Brealey, S. (Stephen); Rangan, A. (Amar); Torgerson, D. J. (David); Dennis, L. (Laura); Armstrong, A. (Alison); Chuang, L-H. (Ling-Hsiang); Cross, B. (Ben); Dumville, J. C. (Joanne); Gardner, S. (Sarah); Goodchild, L. M. (Lorna); Hamilton, S. (Sharon); Hewitt, C. (Catherine); Madhok, R. (Rajan); Maffulli, N. (Nicola); Micklewright, L. (Lucy); Wadsworth, V. (Valerie); Wallace, A. (Angus); Williams, J. (John); Worthy, G. (Gill)
Affiliation:
Teesside University. Centre for Rehabilitation Sciences. Health Sciences and Social Care Institute.
Citation:
Handoll, H. H. G. et al. (2009) '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', BMC Musculoskeletal Disorders, 10 (1), Art. no. 140
Publisher:
BioMed Central
Journal:
BMC Musculoskeletal Disorders
Issue Date:
2009
URI:
http://hdl.handle.net/10149/95689
DOI:
10.1186/1471-2474-10-140
Abstract:
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/Design: 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. Discussion: 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.
Type:
Article
Language:
en
Keywords:
humerus; proximal fracture; randomised controlled trial; adults; surgical treatment; non-surgical treatment
ISSN:
1471-2474
Rights:
Author can archive publisher's version/PDF. For full details see http://www.sherpa.ac.uk/romeo/ [Accessed 06/04/2010]
Citation Count:
0 [Scopus, 06/04/2010]

Full metadata record

DC FieldValue Language
dc.contributor.authorHandoll, H. H. G. (Helen)en
dc.contributor.authorBrealey, S. (Stephen)en
dc.contributor.authorRangan, A. (Amar)en
dc.contributor.authorTorgerson, D. J. (David)en
dc.contributor.authorDennis, L. (Laura)en
dc.contributor.authorArmstrong, A. (Alison)en
dc.contributor.authorChuang, L-H. (Ling-Hsiang)en
dc.contributor.authorCross, B. (Ben)en
dc.contributor.authorDumville, J. C. (Joanne)en
dc.contributor.authorGardner, S. (Sarah)en
dc.contributor.authorGoodchild, L. M. (Lorna)en
dc.contributor.authorHamilton, S. (Sharon)en
dc.contributor.authorHewitt, C. (Catherine)en
dc.contributor.authorMadhok, R. (Rajan)en
dc.contributor.authorMaffulli, N. (Nicola)en
dc.contributor.authorMicklewright, L. (Lucy)en
dc.contributor.authorWadsworth, V. (Valerie)en
dc.contributor.authorWallace, A. (Angus)en
dc.contributor.authorWilliams, J. (John)en
dc.contributor.authorWorthy, G. (Gill)en
dc.date.accessioned2010-04-06T12:22:28Z-
dc.date.available2010-04-06T12:22:28Z-
dc.date.issued2009-
dc.identifier.citationBMC Musculoskeletal Disorders; 10 (1): Art. no. 140en
dc.identifier.issn1471-2474-
dc.identifier.doi10.1186/1471-2474-10-140-
dc.identifier.urihttp://hdl.handle.net/10149/95689-
dc.description.abstractBackground: 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/Design: 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. Discussion: 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.en
dc.language.isoenen
dc.publisherBioMed Centralen
dc.rightsAuthor can archive publisher's version/PDF. For full details see http://www.sherpa.ac.uk/romeo/ [Accessed 06/04/2010]en
dc.subjecthumerusen
dc.subjectproximal fractureen
dc.subjectrandomised controlled trialen
dc.subjectadultsen
dc.subjectsurgical treatmenten
dc.subjectnon-surgical treatmenten
dc.titleProtocol 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 adultsen
dc.typeArticleen
dc.contributor.departmentTeesside University. Centre for Rehabilitation Sciences. Health Sciences and Social Care Institute.en
dc.identifier.journalBMC Musculoskeletal Disordersen
ref.citationcount0 [Scopus, 06/04/2010]en
or.citation.harvardHandoll, H. H. G. et al. (2009) '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', BMC Musculoskeletal Disorders, 10 (1), Art. no. 140-
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