A combined randomised and observational study of surgery for fractures in the distal radius in the elderly (CROSSFIRE) - A study protocol

Ian A. Harris, Justine M. Naylor, Andrew Lawson, Rachelle Buchbinder, Rebecca Ivers, Zsolt Balogh, Paul Smith, Rajat Mittal, Wei Xuan, Kirsten Howard, Arezoo Vafa, Piers Yates, Bertram Rieger, Geoff Smith, Ilia Elkinson, Woosung Kim, Mellick Chehade, Jai Sungaran, Kim Latendresse, James Wong & 11 others Sameer Viswanathan, Martin Richardson, Kush Shrestha, Herwig Drobetz, Phong Tran, Jeremy Loveridge, Richard Page, Raphael Hau, Roger Bingham, Jonathan Mulford, Ian Incoll

Research output: Contribution to journalArticleOtherpeer-review

Abstract

Fractures of the distal radius are common and occur in all age groups. The incidence is high in older populations due to osteoporosis and increased falls risk. Considerable practice variation exists in the management of distal radius fractures in older patients ranging from closed reduction with cast immobilisation to open reduction with plate fixation. Plating is currently the most common surgical treatment. While there is evidence showing no significant advantage for some forms of surgical fixation over conservative treatment, and no difference between different surgical techniques, there is a lack of evidence comparing two of the most common treatments used: closed reduction and casting versus plating. Surgical management involves significant costs and risks compared with conservative management. High-level evidence is required to address practice variation, justify costs and to provide the best clinical outcomes for patients. Methods and analysis This pragmatic, multicentre randomised comparative effectiveness trial aims to determine whether plating leads to better pain and function and is more cost-effective than closed reduction and casting of displaced distal radius fractures in adults aged 60 years and older. The trial will compare the two techniques but will also follow consenting patients who are unwilling to be randomised in a separate, observational cohort. Inclusion of non-randomised patients addresses selection bias, provides practice and outcome insights about standard care, and improves the generalisability of the results from the randomised trial. Ethics and dissemination CROSSFIRE(Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly) was reviewed and approved by The Hunter New England HREC (HNEHREC Reference No: 16/02/17/3.04). The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Results will be incorporated in clinical recommendations and practice guidelines produced by professional bodies. Registration CROSSFIRE has been registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR: ACTRN12616000969460).

Original languageEnglish
Article numbere016100
JournalBMJ Open
Volume7
Issue number6
DOIs
Publication statusPublished - 1 Jun 2017
Externally publishedYes

Keywords

  • Aged
  • Cost-benefit
  • Fracture Fixation
  • PatientReported Outcome
  • Radius Fractures

Cite this

Harris, Ian A. ; Naylor, Justine M. ; Lawson, Andrew ; Buchbinder, Rachelle ; Ivers, Rebecca ; Balogh, Zsolt ; Smith, Paul ; Mittal, Rajat ; Xuan, Wei ; Howard, Kirsten ; Vafa, Arezoo ; Yates, Piers ; Rieger, Bertram ; Smith, Geoff ; Elkinson, Ilia ; Kim, Woosung ; Chehade, Mellick ; Sungaran, Jai ; Latendresse, Kim ; Wong, James ; Viswanathan, Sameer ; Richardson, Martin ; Shrestha, Kush ; Drobetz, Herwig ; Tran, Phong ; Loveridge, Jeremy ; Page, Richard ; Hau, Raphael ; Bingham, Roger ; Mulford, Jonathan ; Incoll, Ian. / A combined randomised and observational study of surgery for fractures in the distal radius in the elderly (CROSSFIRE) - A study protocol. In: BMJ Open. 2017 ; Vol. 7, No. 6.
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title = "A combined randomised and observational study of surgery for fractures in the distal radius in the elderly (CROSSFIRE) - A study protocol",
abstract = "Fractures of the distal radius are common and occur in all age groups. The incidence is high in older populations due to osteoporosis and increased falls risk. Considerable practice variation exists in the management of distal radius fractures in older patients ranging from closed reduction with cast immobilisation to open reduction with plate fixation. Plating is currently the most common surgical treatment. While there is evidence showing no significant advantage for some forms of surgical fixation over conservative treatment, and no difference between different surgical techniques, there is a lack of evidence comparing two of the most common treatments used: closed reduction and casting versus plating. Surgical management involves significant costs and risks compared with conservative management. High-level evidence is required to address practice variation, justify costs and to provide the best clinical outcomes for patients. Methods and analysis This pragmatic, multicentre randomised comparative effectiveness trial aims to determine whether plating leads to better pain and function and is more cost-effective than closed reduction and casting of displaced distal radius fractures in adults aged 60 years and older. The trial will compare the two techniques but will also follow consenting patients who are unwilling to be randomised in a separate, observational cohort. Inclusion of non-randomised patients addresses selection bias, provides practice and outcome insights about standard care, and improves the generalisability of the results from the randomised trial. Ethics and dissemination CROSSFIRE(Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly) was reviewed and approved by The Hunter New England HREC (HNEHREC Reference No: 16/02/17/3.04). The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Results will be incorporated in clinical recommendations and practice guidelines produced by professional bodies. Registration CROSSFIRE has been registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR: ACTRN12616000969460).",
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author = "Harris, {Ian A.} and Naylor, {Justine M.} and Andrew Lawson and Rachelle Buchbinder and Rebecca Ivers and Zsolt Balogh and Paul Smith and Rajat Mittal and Wei Xuan and Kirsten Howard and Arezoo Vafa and Piers Yates and Bertram Rieger and Geoff Smith and Ilia Elkinson and Woosung Kim and Mellick Chehade and Jai Sungaran and Kim Latendresse and James Wong and Sameer Viswanathan and Martin Richardson and Kush Shrestha and Herwig Drobetz and Phong Tran and Jeremy Loveridge and Richard Page and Raphael Hau and Roger Bingham and Jonathan Mulford and Ian Incoll",
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Harris, IA, Naylor, JM, Lawson, A, Buchbinder, R, Ivers, R, Balogh, Z, Smith, P, Mittal, R, Xuan, W, Howard, K, Vafa, A, Yates, P, Rieger, B, Smith, G, Elkinson, I, Kim, W, Chehade, M, Sungaran, J, Latendresse, K, Wong, J, Viswanathan, S, Richardson, M, Shrestha, K, Drobetz, H, Tran, P, Loveridge, J, Page, R, Hau, R, Bingham, R, Mulford, J & Incoll, I 2017, 'A combined randomised and observational study of surgery for fractures in the distal radius in the elderly (CROSSFIRE) - A study protocol' BMJ Open, vol. 7, no. 6, e016100. https://doi.org/10.1136/bmjopen-2017-016100

A combined randomised and observational study of surgery for fractures in the distal radius in the elderly (CROSSFIRE) - A study protocol. / Harris, Ian A.; Naylor, Justine M.; Lawson, Andrew; Buchbinder, Rachelle; Ivers, Rebecca; Balogh, Zsolt; Smith, Paul; Mittal, Rajat; Xuan, Wei; Howard, Kirsten; Vafa, Arezoo; Yates, Piers; Rieger, Bertram; Smith, Geoff; Elkinson, Ilia; Kim, Woosung; Chehade, Mellick; Sungaran, Jai; Latendresse, Kim; Wong, James; Viswanathan, Sameer; Richardson, Martin; Shrestha, Kush; Drobetz, Herwig; Tran, Phong; Loveridge, Jeremy; Page, Richard; Hau, Raphael; Bingham, Roger; Mulford, Jonathan; Incoll, Ian.

In: BMJ Open, Vol. 7, No. 6, e016100, 01.06.2017.

Research output: Contribution to journalArticleOtherpeer-review

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T1 - A combined randomised and observational study of surgery for fractures in the distal radius in the elderly (CROSSFIRE) - A study protocol

AU - Harris, Ian A.

AU - Naylor, Justine M.

AU - Lawson, Andrew

AU - Buchbinder, Rachelle

AU - Ivers, Rebecca

AU - Balogh, Zsolt

AU - Smith, Paul

AU - Mittal, Rajat

AU - Xuan, Wei

AU - Howard, Kirsten

AU - Vafa, Arezoo

AU - Yates, Piers

AU - Rieger, Bertram

AU - Smith, Geoff

AU - Elkinson, Ilia

AU - Kim, Woosung

AU - Chehade, Mellick

AU - Sungaran, Jai

AU - Latendresse, Kim

AU - Wong, James

AU - Viswanathan, Sameer

AU - Richardson, Martin

AU - Shrestha, Kush

AU - Drobetz, Herwig

AU - Tran, Phong

AU - Loveridge, Jeremy

AU - Page, Richard

AU - Hau, Raphael

AU - Bingham, Roger

AU - Mulford, Jonathan

AU - Incoll, Ian

PY - 2017/6/1

Y1 - 2017/6/1

N2 - Fractures of the distal radius are common and occur in all age groups. The incidence is high in older populations due to osteoporosis and increased falls risk. Considerable practice variation exists in the management of distal radius fractures in older patients ranging from closed reduction with cast immobilisation to open reduction with plate fixation. Plating is currently the most common surgical treatment. While there is evidence showing no significant advantage for some forms of surgical fixation over conservative treatment, and no difference between different surgical techniques, there is a lack of evidence comparing two of the most common treatments used: closed reduction and casting versus plating. Surgical management involves significant costs and risks compared with conservative management. High-level evidence is required to address practice variation, justify costs and to provide the best clinical outcomes for patients. Methods and analysis This pragmatic, multicentre randomised comparative effectiveness trial aims to determine whether plating leads to better pain and function and is more cost-effective than closed reduction and casting of displaced distal radius fractures in adults aged 60 years and older. The trial will compare the two techniques but will also follow consenting patients who are unwilling to be randomised in a separate, observational cohort. Inclusion of non-randomised patients addresses selection bias, provides practice and outcome insights about standard care, and improves the generalisability of the results from the randomised trial. Ethics and dissemination CROSSFIRE(Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly) was reviewed and approved by The Hunter New England HREC (HNEHREC Reference No: 16/02/17/3.04). The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Results will be incorporated in clinical recommendations and practice guidelines produced by professional bodies. Registration CROSSFIRE has been registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR: ACTRN12616000969460).

AB - Fractures of the distal radius are common and occur in all age groups. The incidence is high in older populations due to osteoporosis and increased falls risk. Considerable practice variation exists in the management of distal radius fractures in older patients ranging from closed reduction with cast immobilisation to open reduction with plate fixation. Plating is currently the most common surgical treatment. While there is evidence showing no significant advantage for some forms of surgical fixation over conservative treatment, and no difference between different surgical techniques, there is a lack of evidence comparing two of the most common treatments used: closed reduction and casting versus plating. Surgical management involves significant costs and risks compared with conservative management. High-level evidence is required to address practice variation, justify costs and to provide the best clinical outcomes for patients. Methods and analysis This pragmatic, multicentre randomised comparative effectiveness trial aims to determine whether plating leads to better pain and function and is more cost-effective than closed reduction and casting of displaced distal radius fractures in adults aged 60 years and older. The trial will compare the two techniques but will also follow consenting patients who are unwilling to be randomised in a separate, observational cohort. Inclusion of non-randomised patients addresses selection bias, provides practice and outcome insights about standard care, and improves the generalisability of the results from the randomised trial. Ethics and dissemination CROSSFIRE(Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly) was reviewed and approved by The Hunter New England HREC (HNEHREC Reference No: 16/02/17/3.04). The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Results will be incorporated in clinical recommendations and practice guidelines produced by professional bodies. Registration CROSSFIRE has been registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR: ACTRN12616000969460).

KW - Aged

KW - Cost-benefit

KW - Fracture Fixation

KW - PatientReported Outcome

KW - Radius Fractures

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