Site-specific details

Matthew L Costa; Juul Achten; Susie Hennings; Nafisa Boota; James Griffin; Stavros Petrou; Mandy Maredza; Melina Dritsaki; Thomas Wood; James Masters; Ian Pallister; Sarah E Lamb; Nick R Parsons

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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 1Site-specific details

TABLE 27

Reasons screened patients were not eligible for the study, by site

Reason	Site (n)																										Total, n (%)
Reason	University Hospitals Coventry & Warwickshire	Addenbrookes Hospital	Frenchay Hospital	University Hospitals of Leicester	Nottingham University Hospitals	James Cook Hospital	John Radcliffe Hospital	Aberdeen Royal Infirmary	Derriford Hospital	Royal Stoke University Hospital	Royal Sussex County Hospital	Royal Victoria Infirmary	Glasgow Royal Infirmary	Royal Berkshire Hospital	Poole Hospital	Queen Alexandra Hospital	King’s College Hospital	Aintree University Hospital	Southampton General Hospital	University Hospitals of Birmingham	Leeds Teaching Hospital	St George’s Hospital	Hull Royal Infirmary	North Tyneside General Hospital & Wansbeck General	Heartlands Hospital	Sunderland Royal Hospital	Total, n (%)
Aged < 16 years	13	0	36	5	0	19	23	0	0	0	0	0	2	4	9	10	0	0	0	0	7	1	0	3	2	0	134 (8)
Fracture does not extend within 2 Müller squares	28	23	76	27	7	35	26	2	4	21	19	5	3	7	15	11	1	13	14	25	8	0	2	3	0	0	375 (24)
Surgeon thinks patient would not benefit	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	2 (< 1)
Surgeon believes no operation preferable	6	0	22	6	4	0	12	7	2	1	2	7	1	3	12	0	0	1	0	7	6	0	3	3	3	0	108 (7)
Surgeon believes external fixation preferable	5	1	0	1	2	4	4	0	0	4	1	0	0	2	3	0	0	0	2	2	23	0	5	1	1	2	63 (4)
Surgeon believes contraindication to nail	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	4 (< 1)
Fracture too low for distal locking screws	8	1	11	4	0	5	1	3	1	1	1	2	3	0	6	3	0	3	0	5	4	0	0	3	0	0	65 (4)
Obstruction to IM nail	4	0	3	1	0	2	1	2	2	0	0	1	0	0	1	0	0	0	0	5	2	2	0	1	0	0	27 (2)
Fracture is open	21	16	84	8	4	22	61	18	0	4	22	22	19	0	7	2	0	0	6	4	6	41	0	2	0	0	369 (23)
Patient contraindication to anaesthesia	1	0	6	2	1	0	2	2	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	16 (1)
Patient has permanent cognitive impairment	4	9	11	0	3	5	7	9	1	5	1	3	12	1	1	2	1	1	2	2	5	0	0	3	0	1	89 (6)
Fracture extends in to the ankle joint	5	7	39	4	6	25	19	23	5	9	37	14	18	2	17	7	3	4	1	22	33	4	12	12	1	0	329 (21)
Total	95	57	289	59	27	117	157	66	15	45	83	54	58	21	72	36	5	22	25	73	94	48	22	31	7	3	1581

TABLE 28

Reasons potentially eligible patients were not recruited to the study, by site

Reason	Site (n)																										Total, n (%)
Reason	University Hospitals Coventry & Warwickshire	Addenbrookes Hospital	Frenchay Hospital	University Hospitals of Leicester	Nottingham University Hospitals	James Cook Hospital	John Radcliffe Hospital	Aberdeen Royal Infirmary	Derriford Hospital	Royal Stoke University Hospital	Royal Sussex County Hospital	Royal Victoria Infirmary	Glasgow Royal Infirmary	Royal Berkshire Hospital	Poole Hospital	Queen Alexandra Hospital	King’s College Hospital	Aintree University Hospital	Southampton General Hospital	University Hospitals of Birmingham	Leeds Teaching Hospital	St George’s Hospital	Hull Royal Infirmary	North Tyneside General Hospital & Wansbeck General	Heartlands Hospital	Sunderland Royal Hospital	Total, n (%)
Patient wants nail	3	1	1	1	3	0	1	4	0	0	0	0	3	0	1	2	0	0	0	0	3	0	0	0	0	0	23 (11)
Patient wants plate	0	0	1	2	0	1	1	0	0	0	0	0	0	1	6	1	0	0	0	1	1	0	0	0	0	0	15 (7)
Patient does not want surgery	1	0	1	0	0	0	0	1	0	0	0	0	1	0	1	0	0	0	0	1	5	0	2	0	0	0	13 (6)
Patient does not want to be part of research study	3	2	1	1	0	0	0	5	0	2	0	0	3	3	0	0	0	0	0	1	3	0	1	0	0	0	25 (12)
Patient does not want to complete questionnaires	1	0	1	0	0	3	0	2	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	9 (4)
Research staff unavailable	1	2	13	2	0	2	3	0	0	1	4	3	4	1	5	2	0	1	4	3	1	0	0	1	0	0	53 (25)
Surgeon preferred nail	0	5	8	0	3	1	2	5	3	1	13	0	3	3	0	0	0	0	2	0	2	0	3	0	0	0	54 (25)
Surgeon preferred plate	0	0	1	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3 (1)
Other	1	0	2	1	0	0	1	0	0	3	0	2	0	0	4	1	0	0	2	0	1	0	0	0	0	0	18 (8)
No reason given	0	0	0	0	0	1	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3 (1)
Total	10	10	29	8	6	8	8	17	3	12	17	7	14	8	17	10	0	1	9	6	16	0	6	1	0	0	216

TABLE 29

Recruitment by site and month

Site	Date open	Year (n)																		Total (n)	Months (n)	Rate (n)
		2013	2014	2015												2016
		2013	2014	January	February	March	April	May	June	July	August	September	October	November	December	January	February	March	April
University Hospitals Coventry & Warwickshire	8 April 2013	9	14	0	0	0	1	2	4	2	0	1	2	0	1	0	1	1	0	38	36	1.06
Addenbrookes Hospital	2 May 2013	2	7	3	0	1	0	1	0	0	1	0	0	0	0	0	0	0	0	15	35	0.43
Frenchay Hospital	12 June 2013	3	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	8	34	0.24
University Hospitals of Leicester	16 July 2013	6	19	2	1	1	0	2	2	1	3	1	0	2	1	1	1	1	1	45	32	1.41
Nottingham University Hospitals	25 July 2013	4	5	1	1	0	1	1	0	0	0	1	0	0	0	1	0	0	0	15	32	0.47
James Cook Hospital	5 September 2013	1	6	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	9	31	0.29
John Radcliffe Hospital	20 December 2013	0	3	0	0	0	0	0	2	1	0	1	0	1	0	3	3	0	1	15	28	0.54
Aberdeen Royal Infirmary	14 January 2014		8	2	2	1	0	0	0	0	1	0	0	1	1	0	0	0	1	17	27	0.63
Derriford Hospital	15 January 2014		8	0	1	0	1	1	2	0	0	0	0	0	0	0	0	0	0	13	27	0.48
Royal Stoke University Hospital	31 January 2014		3	1	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	6	27	0.22
Royal Sussex County Hospital	3 February 2014		5	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	7	26	0.27
Royal Infirmary of Edinburgh	10 February 2014		1																	1	10	0.10
Royal Victoria Infirmary	10 February 2014		8	1	0	0	1	2	1	1	0	1	1	2	0	0	0	0	0	18	26	0.69
Glasgow Royal Infirmary	11 March 2014		7	0	1	1	1	0	0	0	5	1	0	2	0	1	0	1	0	20	26	0.77
Royal Berkshire Hospital	8 May 2014		1	0	0	0	0	0	1	0	1	1	1	1	0	0	0	0	0	6	24	0.25
Poole Hospital	13 May 2014		2	0	1	0	1	0	0	0	2	0	1	0	2	0	0	0	0	9	24	0.38
Queen Alexandra Hospital	29 May 2014		2	1	0	1	2	1	1	0	1	3	0	0	1	0	0	0	0	13	24	0.54
King’s College Hospital	10 June 2014		1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	2	23	0.09
Aintree University Hospital	15 July 2014		1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	22	0.09
Southampton General Hospital	4 August 2014		1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	2	21	0.10
University Hospitals of Birmingham	6 August 2014		1	1	0	0	0	0	0	0	1	1	1	0	0	0	0	0	0	5	21	0.24
Leeds Teaching Hospital	12 August 2014		2	3	1	2	0	3	2	1	0	1	1	1	2	2	0	0	0	21	21	1.00
St George’s Hospital	10 September 2014		2	1	0	0	0	1	0	0	1	1	0	0	0	0	0	0	0	6	20	0.30
Hull Royal Infirmary	13 October 2014		0	0	0	3	1	2	0	0	0	0	1	0	0	0	0	1	0	8	19	0.42
North Tyneside General Hospital & Wansbeck General	20 November 2014		2	0	1	1	0	0	1	1	0	1	0	0	0	0	1	1	2	11	18	0.61
Heartlands Hospital	3 February 2015				2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	15	0.13
Sunderland Royal Hospital	4 March 2015					2	1	1	0	1	0	0	0	1	0	0	0	0	0	6	14	0.43
Basingstoke & North Hampshire Hospital	1 April 2015						0	0	0	0	0	0	0	0	1	0	0	0	0	1	13	0.08
Total		25	114	16	12	15	11	17	17	8	17	16	8	11	10	8	6	5	5	321	676	0.47

TABLE 30

Randomised patients summarised by treatment group and centre

Site	Treatment group (n)		Total
Site	IM nail fixation	Locking plate	Total
Aberdeen Royal Infirmary	9	8	17
Addenbrookes Hospital	7	8	15
Aintree University Hospital	1	1	2
Heartlands Hospital	1	1	2
Basingstoke & North Hampshire Hospital	1	0	1
Royal Infirmary of Edinburgh	1	0	1
Frenchay Hospital	4	4	8
Glasgow Royal Infirmary	10	10	20
Hull Royal Infirmary	5	5	10
James Cook Hospital	5	4	9
John Radcliffe Hospital	7	8	15
King’s College Hospital	1	1	2
Leeds Teaching Hospital	10	11	21
North Tyneside General Hospital & Wansbeck General	5	4	9
Nottingham University Hospitals	8	7	15
Derriford Hospital	6	7	13
Poole Hospital	4	5	9
Queen Alexandra Hospital	7	6	13
Royal Berkshire Hospital	3	3	6
Royal Sussex County Hospital	3	4	7
Royal Victoria Infirmary	8	10	18
St George’s Hospital	3	3	6
Sunderland Royal Hospital	3	3	6
University Hospitals of Birmingham	3	2	5
University Hospitals Coventry & Warwickshire	19	19	38
University Hospitals of Leicester	23	22	45
Southampton General Hospital	1	1	2
Royal Stoke University Hospital	3	3	6
Total	161	160	321

TABLE 31

Randomised patients summarised by randomisation strata (recruiting site and age group)

Site	Age (years) group (n)
	< 50		≥ 50
	IM nail fixation	Locking plate	IM nail fixation	Locking plate
Aberdeen Royal Infirmary	7	6	2	2
Addenbrookes Hospital	4	4	3	4
Aintree University Hospital	1	0	0	1
Heartlands Hospital	0	1	1	0
Basingstoke & North Hampshire Hospital	0	0	1	0
Royal Infirmary of Edinburgh	0	0	1	0
Frenchay Hospital	2	2	2	2
Glasgow Royal Infirmary	5	4	5	6
Hull Royal Infirmary	2	4	3	1
James Cook Hospital	3	3	2	1
John Radcliffe Hospital	5	6	2	2
King’s College Hospital	1	1	0	0
Leeds Teaching Hospital	3	6	7	5
North Tyneside General Hospital & Wansbeck General	3	4	2	0
Nottingham University Hospitals	6	5	2	2
Derriford Hospital	3	5	3	2
Poole Hospital	4	2	0	3
Queen Alexandra Hospital	5	2	2	4
Royal Berkshire Hospital	3	1	0	2
Royal Sussex County Hospital	3	3	0	1
Royal Victoria Infirmary	8	7	0	3
St George’s Hospital	2	2	1	1
Sunderland Royal Hospital	3	2	0	1
University Hospitals of Birmingham	1	1	2	1
University Hospitals Coventry & Warwickshire	11	12	8	7
University Hospitals of Leicester	11	11	12	11
Southampton General Hospital	1	0	0	1
Royal Stoke University Hospital	0	3	3	0
Total	97	97	64	63

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.

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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.) Appendix 1, Site-specific details.
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