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Costa ML, Achten J, Hennings S, et al. Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT. Southampton (UK): NIHR Journals Library; 2018 May. (Health Technology Assessment, No. 22.25.)

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Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT.

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Appendix 6Protocol amendments

TABLE 39

List of amendments to the trial protocol

VersionDate of approvalReason for change
Amendment numberDate
119 December 20122 January 2013Alteration of filter question 7
217 March 20135 April 2013Changes in participant ‘consent’
3N/AN/AN/A
414 August 201314 October 2013Data collection in clinic
530 October 201322 November 2013Change in eligibility criteria
61 March 201412 March 2014Clarification of eligibility criteria
7N/AN/AN/A
821 May 201420 June 2014Updated the contact details of the sponsor and trial staff details and added main phase sites
924 June 201422 July 2014Clarification on how the randomisation is implemented
1026 February 201520 April 2015Opt-in option for long-term follow-up at the outset of the study and addendum foot pressure walking study

N/A, not applicable.

Copyright © Queen’s Printer and Controller of HMSO 2018. This work was produced by Costa et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Bookshelf ID: NBK500114
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