Study concept and design: Rangan, Handoll, Brealey, Goodchild, Chuang, Torgerson.
Acquisition, analysis, or interpretation of data: Rangan, Handoll, Brealey, Jefferson, Keding, Martin, Goodchild, Hewitt.
Drafting of the manuscript: Rangan, Handoll, Brealey, Jefferson, Torgerson.
Critical revision of the manuscript for important intellectual content: Rangan, Handoll, Brealey, Jefferson, Keding, Martin, Goodchild, Chuang, Hewitt.
Statistical analysis: Keding, Martin, Chuang, Hewitt.
Obtained funding: Rangan, Handoll, Brealey, Torgerson.
Administrative, technical, or material support: Brealey, Jefferson, Goodchild, Torgerson.
Study supervision: Rangan, Handoll, Brealey, Torgerson.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Rangan reported receiving grants and personal fees from DePuy Ltd; receiving grants from JRI Ltd; and having a UK and European patent pending for a shoulder replacement prosthesis. No other disclosures were reported.
Funding/Support: This trial was funded by the National Institute for Health Research, Health Technology Assessment Programme (project No. 06/404/53) and will be published in full in UK Health Technology Assessment.
Role of the Funder/Sponsor: Teesside University managed the grant application process and monitored the study but it had no direct role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group Information: The PROFHER Trial principal investigators (and study sites) were Tim Peckham, FRCS(T&O) (Basildon and Thurrock University Hospitals); Nigel Rossiter, FRCS(T&O) (Basingstoke and North Hampshire Hospital); Socrates Kalogrianitis, FRCS(T&O) (Queen Elizabeth Hospital Birmingham); Charalambos P. Charalambous, FRCS(T&O) (Blackpool Victoria Hospital); Mark Crowther FRCS(T&O) (Frenchay Hospital Bristol); Matthew Costa, PhD, FRCS(T&O) (University Hospitals of Coventry and Warwickshire); Amit Sinha, FRCS(T&O) (Ysbyty Glan Clwyd Hospital); Sunil Sharma, FRCS(T&O) (Queen Margaret Hospital, Fife); Christopher Roberts, FRCS(T&O) (Ipswich Hospital); Amar Rangan, ChM, FRCS(T&O) (James Cook University Hospital, Middlesbrough); Joydeep Sinha, FRCS(T&O) (King’s College Hospital); Roger Hackney, FRCS(T&O) (Leeds General Infirmary); Alison Armstrong, FRCS(T&O) (Leicester General Hospital); Mohammad Maqsood, FRCS(T&O) (Lincoln County Hospital); Dilraj Sandher, FRCS(T&O) (Manchester Royal Infirmary); Andrew Gray, FRCS(T&O) (Newcastle Royal Victoria Infirmary); Simon Donell, MD, FRCS(T&O) (Norfolk and Norwich University Hospital); Damian McClelland, FRCS(T&O) (University Hospital of North Staffordshire); Alan Middleton, FRCS(T&O) (University Hospital of North Tees); Roland Pratt, FRCS(T&O) (North Tyneside General Hospital); Alistair Jepson, FRCS(T&O) (Northampton General Hospital); Angus Wallace, FRCS(T&O) (Nottingham University Hospital); Keith Willett, FRCS(T&O) (John Radcliffe Hospital); Makaram Srinivasan, FRCS(T&O) (Royal Blackburn Hospital); Leo Jacobs, FRCS (Royal Oldham Hospital); Robin Seagger, FRCS(T&O) (Royal Oldham Hospital); Matthew Smith, FRCS(T&O) (Royal Liverpool and Broadgreen University Hospitals); Simon-Owen Johnstone, FRCS(T&O) (Barts and London Hospitals); Muthu Jeyam, FRCS(T&O) (Salford Royal Hospital); Owais Shafqat, FRCS(T&O) (Scunthorpe General Hospital); William Loh, FRCS(T&O) (Southport and Ormskirk District General Hospital); Jayant Nadkarni, FRCS(T&O) (Southport and Ormskirk District General Hospital); Lisa Tourett, FRCS(T&O) (Sunderland Royal Hospital); Veronica Conboy, FRCS(T&O) (Torbay Hospital); Bibhas Roy, FRCS(T&O) (Trafford General Hospital); Jaime Candal-Couto, FRCS(T&O) (Wansbeck General Hospital, Northumbria); Andrew Chambler, FRCS(T&O) (Yeovil District Hospital); and John Smibert, FRCS(T&O) (Yeovil District Hospital).
Disclaimer: The views expressed are those of the authors and not necessarily those of the UK National Institute for Health Research, the UK National Health Service, or the UK Department of Health.
Additonal Contributions: We thank all the patients who participated in this trial, and the principal investigators, research nurses, and physiotherapists, and all other collaborators at the hospital sites and in the community involved in conducting the trial, thereby ensuring its success. These contributors and the contributing hospitals and primary care trusts are named in the full trial report. A full list of the names of colleagues based in James Cook University Hospital, Teesside University, University of York and elsewhere are presented with details of their specific contributions in the Acknowledgments of the full report to be published later. The independent members of the trial steering committee were Sarah Purdy, MD (chair), Andrew Carr, FMedSci, and Brian Faragher, PhD; Dorothy Anderson and Margaret Newlands (patient representatives); and Alasdair MacSween, PhD (sponsor representative). The independent members of the data monitoring and ethics committee were Marion Campbell, PhD (chair), Roger Francis, FRCP, and David Limb, MD.