Clinical results: intention-to-treat analysis

David J Keene; Dipesh Mistry; Julian Nam; Elizabeth Tutton; Robert Handley; Lesley Morgan; Emma Roberts; Bridget Gray; Andrew Briggs; Ranjit Lall; Tim JS Chesser; Ian Pallister; Sarah E Lamb; Keith Willett

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Keene DJ, Mistry D, Nam J, et al. The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years. Southampton (UK): NIHR Journals Library; 2016 Oct. (Health Technology Assessment, No. 20.75.)

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The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years.

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Appendix 2Clinical results: intention-to-treat analysis

Intention-to-treat analyses results

The results from the ITT analyses of the primary and secondary outcomes are presented in this section of the appendix. The ITT analyses displayed similar results to that of the per-protocol analyses.

FIGURE 23

Plot of mean scores and 95% CIs for the OMASs over time (ITT).

FIGURE 24

Plot of mean scores and 95% CIs for the SF-12 mental component summary score over time (ITT).

FIGURE 25

Plot of means and 95% CIs for the SF-12 physical component summary score over time (ITT).

FIGURE 26

Plot of means and 95% CIs for the EQ-5D score over time (ITT).

TABLE 47

Summary of SF-12 and EQ-5D outcomes at the 6-week and 6-month assessments (ITT)

Outcome	Treatment group		Unadjusted statistics (95% CI); p-value	Adjusted statistics (95% CI); p-value
Outcome	ORIF	CCC	Unadjusted statistics (95% CI); p-value	Adjusted statistics (95% CI); p-value
SF-12 mental component summary score
6 weeks
Mean	48.3	48.7	0.34 (–1.40 to 2.09); 0.700	–0.14 (–1.78, 1.50); 0.864
n	304	302
SD	11.27	10.57
Median	49.1	49.6
Minimum	16.5	19.2
Maximum	70.2	68.3
Missing	1	1
6 months
Mean	52.0	52.2	0.21 (–1.42 to 1.83); 0.805	–0.11 (–1.55, 1.33); 0.876
n	298	294
SD	10.47	9.68
Median	55.4	55.7
Minimum	18.9	19.9
Maximum	66.9	68.4
Missing	0	1
SF-12 physical component summary score
6 weeks
Mean	33.4	33.3	–0.02 (–1.10 to 1.05); 0.967	0.15 (–0.90 to 1.20); 0.783
n	304	302
SD	6.94	6.55
Median	32.5	32.7
Minimum	18.4	18.3
Maximum	57.1	54.9
Missing	1	1
6 months
Mean	45.6	44.2	–1.34 (–3.00 to 0.32); 0.113	–0.59 (–2.08 to 0.91); 0.440
n	298	294
SD	10.01	10.56
Median	46.9	45.4
Minimum	22.1	15.6
Maximum	66.2	64.3
Missing	0	1
EQ-5D mobility score
6 weeks
Level 1, n (%)	11 (3.6)	7 (2.3)	0.292
Level 2, n (%)	248 (81.3)	243 (80.2)
Level 3, n (%)	17 (5.6)	25 (8.3)
Missing, n (%)	29 (9.5)	28 (9.2)
6 months
Level 1, n (%)	135 (45.3)	120 (40.7)	0.475
Level 2, n (%)	131 (44.0)	144 (48.8)
Level 3, n (%)	3 (1.0)	3 (1.0)
Missing, n (%)	29 (9.7)	28 (9.5)
EQ-5D self-care score
6 weeks
Level 1, n (%)	167 (54.8)	149 (49.1)	0.028
Level 2, n (%)	108 (35.4)	118 (38.9)
Level 3, n (%)	1 (0.3)	8 (2.6)
Missing, n (%)	29 (9.5)	28 (9.2)
6 months
Level 1, n (%)	243 (81.5)	246 (83.4)	0.642
Level 2, n (%)	22 (7.5)	19 (6.4)
Level 3, n (%)	4 (1.3)	2 (0.7)
Missing, n (%)	29 (9.7)	28 (9.5)
EQ-5D usual activities score
6 weeks
Level 1, n (%)	11 (3.6)	11 (3.6)	0.023
Level 2, n (%)	152 (49.8)	120 (39.6)
Level 3, n (%)	113 (37.1)	144 (47.5)
Missing, n (%)	29 (9.5)	28 (9.3)
6 months
Level 1, n (%)	161 (54.0)	142 (48.1)	0.265
Level 2, n (%)	98 (32.9)	111 (37.6)
Level 3, n (%)	10 (3.4)	14 (4.8)
Missing, n (%)	29 (9.7)	28 (9.5)
EQ-5D pain/discomfort score
6 weeks
Level 1, n (%)	132 (43.3)	137 (45.2)	0.375
Level 2, n (%)	137 (44.9)	136 (44.9)
Level 3, n (%)	6 (2.0)	2 (0.7)
Missing, n (%)	30 (9.8)	28 (9.2)
6 months
Level 1, n (%)	120 (40.3)	115 (39.0)	0.496
Level 2, n (%)	140 (47.0)	147 (49.8)
Level 3, n (%)	9 (3.0)	5 (1.7)
Missing, n (%)	29 (9.7)	28 (9.5)
EQ-5D anxiety/depression score
6 weeks
Level 1, n (%)	186 (61.0)	179 (59.1)	0.108
Level 2, n (%)	84 (27.5)	95 (31.4)
Level 3, n (%)	6 (2.0)	1 (0.3)
Missing, n (%)	29 (9.5)	28 (9.2)
6 months
Level 1, n (%)	201 (67.4)	210 (71.2)	0.594
Level 2, n (%)	61 (20.5)	52 (17.6)
Level 3, n (%)	6 (2.0)	5 (1.7)
Missing, n (%)	30 (10.1)	28 (9.5)
EQ-5D score
6 weeks
Mean	0.53	0.48	–0.04 (–0.08 to –0.001); 0.047	–0.04 (–0.08 to 0.005); 0.088
n	275	275
SD	0.25	0.25
Median	0.59	0.49
Minimum	–0.48	–0.06
Maximum	1	1
Missing	30	28
6 months
Mean	0.76	0.76	–0.004 (–0.04 to 0.03); 0.814	–0.001 (–0.04 to 0.04); 0.968
n	268	267
SD	0.24	0.22
Median	0.80	0.78
Minimum	–0.36	–0.11
Maximum	1	1
Missing	30	28
EQ-5D VAS score
6 weeks
Mean	72.7	72.0	–0.77 (–3.73 to 2.19); 0.609	–0.39 (–3.13 to 2.36); 0.781
n	276	274
SD	17.28	18.06
Median	75.0	75.0
Minimum	0	10
Maximum	100	100
Missing	29	29
6 months
Mean	77.3	77.4	0.02 (–3.09 to 3.12); 0.991	0.10 (–2.91 to 3.11); 0.947
n	269	267
SD	18.81	17.74
Median	81.0	80.0
Minimum	0	1
Maximum	100	100
Missing	29	28

: A negative value implies that the treatment effect is in favour of ORIF.

TABLE 48

Timed up and go walking test at the 6-month follow-up, summarised by treatment group (ITT)

Timed up and go test (seconds)	Treatment group		p-value^a
Timed up and go test (seconds)	ORIF	CCC	p-value^a
Mean	21.4	21.9	0.095
n	283	267
SD	19.08	13.45
Median	18.0	18.3
Minimum	6.8	7.4
Maximum	224.3	133.0
Missing	0	1

a: Wilcoxon rank-sum test p-value.

TABLE 49

Additional timed up and go test details at the 6-month follow-up, summarised by treatment group (ITT)

Additional timed up and go walking test details	Treatment group		p-value
Additional timed up and go walking test details	ORIF, n (%)	CCC, n (%)	p-value
Completed in under 5 minutes
Yes	282 (99.6)	266 (99.3)	0.614
No	1 (0.4)	2 (0.7)
Missing	0	0
Did patient use walking aid(s)?
Yes	27 (9.5)	32 (11.9)	0.372
No	210 (74.2)	194 (72.4)
Missing	46 (16.3)	42 (15.7)
Unable to complete test because of . . .
Non-weight-bearing	0	1 (0.3)	0.266
Declined to complete test	1 (0.3)	3 (1.0)
Other physical limitation	1 (0.3)	1 (0.3)
Other	13 (4.4)	22 (7.5)
Not applicable	283 (95.0)	268 (90.9)
Missing	0	0

TABLE 50

Range of injured ankle motion at the 6-week and 6-month follow-up (ITT)

Range of ankle motion	Treatment group		Unadjusted statistics (95% CI); p-value	Adjusted statistics (95% CI); p-value
Range of ankle motion	ORIF	CCC	Unadjusted statistics (95% CI); p-value	Adjusted statistics (95% CI); p-value
Angle of injured ankle dorsiflexion (°)
6 weeks
Mean	5.0	4.3	–0.77 (–2.26 to 0.71); 0.306	–0.98 (–2.27 to 0.31); 0.137
n	290	288
SD	8.68	9.46
Median	5	5
Missing	15	15
6 months
Mean	11.9	11.9	0.04 (–1.76 to 1.83); 0.968	0.28 (–1.39 to 1.94); 0.745
n	289	282
SD	10.31	11.49
Median	10	10
Missing	9	13
Angle of injured ankle plantar flexion (°)
6 weeks
Mean	24.5	22.5	–2.05 (–4.18 to 0.08); 0.059	–1.95 (–4.01 to 0.11); 0.064
n	290	288
SD	12.94	13.11
Median	24	20
Missing	15	15
6 months
Mean	33.7	31.3	–2.46 (–4.65 to –0.27); 0.028	–2.23 (–4.25 to –0.21); 0.030
n	289	282
SD	13.68	12.99
Median	35	30
Missing	9	13
Eversion of injured ankle (%)
6 weeks
Mean	49.4	50.2	0.82 (–7.26 to 8.89); 0.842	–0.15 (–8.26 to 7.95); 0.971
n	284	278
SD	40.56	55.84
Median	50	50
Missing	21	25
6 months
Mean	87.6	86.8	–0.79 (–12.30 to 10.71); 0.892	–0.70 (–12.10 to 10.70); 0.904
n	289	277
SD	82.40	53.22
Median	80	80
Missing	9	18
Inversion of injured ankle (%)
6 weeks
Mean	47.9	56.0	8.05 (0.51 to 15.59); 0.036	7.82 (0.16 to 15.47); 0.045
n	288	284
SD	36.21	54.00
Median	45.7	50
Missing	17	19
6 months
Mean	83.3	83.6	0.21 (–8.74 to 9.15); 0.964	0.42 (–8.53 to 9.37); 0.927
n	289	282
SD	64.06	42.29
Median	75	80
Missing	9	13
Started partial weight-bearing
6 weeks
Yes, n (%)	110 (36.1)	119 (39.3)	0.414
No, n (%)	195 (63.9)	184 (60.7)
Missing, n (%)	0	0

: Note: a negative value implies that the treatment effect is in favour of ORIF.

TABLE 51

Summary of the EQ-5D pain item and OMAS pain item at the 6-week and 6-month follow-up (ITT)

Pain outcomes	Treatment group		Unadjusted odds ratio (95% CI); p-value	Adjusted odds ratio (95% CI); p-value
Pain outcomes	ORIF, n (%)	CCC, n (%)	Unadjusted odds ratio (95% CI); p-value	Adjusted odds ratio (95% CI); p-value
EQ-5D pain/discomfort item
6 weeks
No pain/discomfort	132 (43.3)	137 (45.2)	0.90 (0.65 to 1.26); 0.555	0.92 (0.65 to 1.29); 0.622
Moderate pain/discomfort	137 (44.9)	136 (44.9)
Extreme pain/discomfort	6 (2.0)	2 (0.7)
Missing	30 (9.8)	28 (9.2)
6 months
No pain/discomfort	120 (40.3)	115 (39.0)	1.03 (0.73 to 1.44); 0.878	1.05 (0.74 to 1.49); 0.772
Moderate pain/discomfort	140 (47.0)	147 (49.8)
Extreme pain/discomfort	9 (3.0)	5 (1.7)
Missing	29 (9.7)	28 (9.5)
OMAS pain item
6 weeks
None	221 (72.5)	217 (71.6)	1.06 (0.75 to 1.50); 0.746	1.13 (0.78 to 1.62); 0.519
While walking on uneven surface	28 (9.2)	20 (6.6)
While walking on even surface outdoors	9 (2.9)	12 (3.9)
While walking indoors	37 (12.1)	37 (12.2)
Constant and severe	10 (3.3)	15 (5.0)
Missing	0	2 (0.7)
6 months
None	130 (43.6)	137 (46.4)	0.86 (0.64 to 1.16); 0.326	0.90 (0.66 to 1.22); 0.483
While walking on uneven surface	90 (30.2)	91 (30.9)
While walking on even surface outdoors	38 (12.8)	35 (11.9)
While walking indoors	31 (10.4)	20 (6.8)
Constant and severe	9 (3.0)	11 (3.7)
Missing	0	1 (0.3)

TABLE 52

Patient satisfaction at the 6-week and 6-month follow-up (ITT)

Patient satisfaction	Treatment group		Unadjusted odds ratio (95% CI); p-value	Adjusted odds ratio (95% CI); p-value
Patient satisfaction	ORIF, n (%)	CCC, n (%)	Unadjusted odds ratio (95% CI); p-value	Adjusted odds ratio (95% CI); p-value
6 weeks
Very dissatisfied	16 (5.2)	14 (4.6)	1.01 (0.68 to 1.49); 0.976	1.01 (0.68 to 1.50); 0.961
Somewhat dissatisfied	6 (2.0)	9 (3.0)
Neither satisfied nor dissatisfied	8 (2.6)	11 (3.6)
Somewhat satisfied	37 (12.1)	32 (10.6)
Very satisfied	192 (63.0)	193 (63.7)
Missing	46 (15.1)	44 (14.5)
6 months
Very dissatisfied	11 (3.7)	15 (5.1)	1.06 (0.71 to 1.57); 0.790	1.05 (0.69 to 1.59); 0.814
Somewhat dissatisfied	6 (2.0)	6 (2.0)
Neither satisfied nor dissatisfied	13 (4.4)	8 (2.7)
Somewhat satisfied	36 (12.1)	33 (11.2)
Very satisfied	186 (62.4)	188 (63.7)
Missing	46 (15.4)	45 (15.3)

TABLE 53

Summary of radiological malunion at the 6-month follow-up (ITT)

Malunion type^a	Treatment group		Total (N = 556), n (%)
Malunion type^a	ORIF (N = 281), n (%)	CCC (N = 275), n (%)	Total (N = 556), n (%)
No malunion	270 (96.1)	233 (84.7)	503 (90.5)
Talar shift	4 (1.4)	21 (7.6)	25 (4.5)
Talar tilt	1 (0.4)	0	1 (0.2)
Diastasis	0	0	0
Talar shift and talar tilt	3 (1.0)	15 (5.5)	18 (3.2)
Talar shift and diastasis	1 (0.4)	3 (1.1)	4 (0.7)
Talar tilt and diastasis	0	1 (0.4)	1 (0.2)
Talar shift, talar tilt and diastasis	2 (0.7)	2 (0.7)	4 (0.7)
Missing	28	36	64

a: Talar shift (talar subluxation > 2 mm); talar tilt of > 2°; and diastasis (tibiofibular clear space of ≥ 5 mm).

TABLE 54

Summary of radiological malunion and no malunion at the 6-month follow-up (ITT)

Radiological assessment	Treatment group		p-value
Radiological assessment	ORIF (N = 281), n (%)	CCC (N = 275), n (%)	p-value
No malunion	270 (96.1)	233 (84.7)	< 0.001
Malunion	11 (3.9)	42 (15.3)
Missing	28	36

TABLE 55

Summary of radiological non-union at the 6-month follow-up (ITT)

Radiological assessment	Treatment group		p-value
Radiological assessment	ORIF (N = 281), n (%)	CCC (N = 274), n (%)	p-value
Lateral malleolus
Radiologically fracture not united	0	8 (2.9)	0.003
Not injured/no issues with union identified	281 (100)	266 (97.1)
Missing	28	37
Medial malleolus
Radiologically fracture not united	3 (1.1)	20 (7.3)	< 0.001
Not injured/no issues with union identified	278 (98.9)	254 (92.7)
Missing	28	37

TABLE 56

Olerud–Molander Ankle Scores analysed as an ordinal outcome at 6 weeks and 6 months (ITT)

OMAS	Treatment group		Unadjusted odds ratio (95% CI); p-value	Adjusted odds ratio (95% CI); p-value^a
OMAS	ORIF, n (%)	CCC, n (%)	Unadjusted odds ratio (95% CI); p-value	Adjusted odds ratio (95% CI); p-value^a
6 weeks
Poor (0–30%)	98 (32.1)	105 (34.6)	0.94 (0.68 to 1.29); 0.686	0.91 (0.65 to 1.27); 0.561
Fair (31–60%)	193 (63.4)	179 (59.1)
Good (61–90%)	12 (3.9)	17 (5.6)
Excellent (91–100%)	1 (0.3)	0
Missing	1 (0.3)	2 (0.7)
6 months
Poor (0–30%)	19 (6.4)	25 (8.5)	0.90 (0.67 to 1.23); 0.520	0.97 (0.70 to 1.34); 0.854
Fair (31–60%)	95 (31.9)	101 (34.2)
Good (61–90%)	160 (53.7)	135 (45.8)
Excellent (91–100%)	24 (8.0)	33 (11.2)
Missing	0	1 (0.3)

a: Treatment effect estimate using ordinal logistic regression model adjusting for age, sex, hospital, baseline OMAS and AO classification.

TABLE 57

Assessment of the blinding strategy at the 6-month follow-up (ITT)

Treatment received	Blinded assessors guess			Total	James’ Blinding Index (95% CI)
Treatment received	CCC	ORIF	Don’t know	Total	James’ Blinding Index (95% CI)
CCC	38	24	174	236	0.82 (0.79 to 0.84)
ORIF	11	50	180	241
Total	49	74	354	477

TABLE 58

Summary of unadjusted and adjusted time-to-event analyses looking at time to discharge and time to first readmission (ITT)

Event	Number of participants experiencing an event, n (%)	Unadjusted analysis		Adjusted analysis
Event	Number of participants experiencing an event, n (%)	Hazard ratio (95% CI)	p-value	Hazard ratio (95% CI)	p-value
Time to discharge (days)	613 (98.9)	0.97 (0.83 to 1.14)	0.726	1.11 (0.94 to 1.31)	0.230
Time to readmission (days)	89 (14.4)	1.32 (0.82 to 2.11)	0.249	2.05 (1.14 to 3.72)	0.017

TABLE 59

Process variables summarised by treatment group (ITT)

Process variable	Treatment group		Total	p-value
Process variable	ORIF	CCC	Total	p-value
Randomisation
Time from injury to randomisation (days)
Mean	2.8	2.8	2.8	0.804
n	309	311	620
SD	2.66	2.97	2.82
Median	2	2	2
IQR	1–4	1–3.4	1–3.7
Minimum	0	0	0
Maximum	15	28	28
Missing	0	0	0
Randomisation/theatre
Time from randomisation to theatre procedure (days)
Mean	2.2	2.1	2.2	0.789
n	309	306	615
SD	2.55	2.24	2.40
Median	1.0	2.0	1.4
IQR	0–3.4	0–3	0–3
Minimum	0	0	0
Maximum	17	14.4	17
Missing	0	5	5
Treatment
Time from injury to primary treatment (days)
Mean	5.0	4.9	5.0	0.519
n	309	306	615
SD	3.49	3.30	3.39
Median	5.0	4.4	4.4
IQR	2–7	2–7	2–7
Minimum	0	0	0
Maximum	19	18	19
Missing	0	5	5
Theatre
Time from entry into anaesthetic room to start time in theatre (minutes)
Mean	29.2	18.0	23.6	< 0.001
n	306	306	612
SD	14.78	10.74	14.06
Median	27.0	16.0	21.0
IQR	18–37	10–24	14–30
Minimum	0	0	0
Maximum	90	100	100
Missing	3	5	8
Time from start to end of procedure in theatre (minutes)
Mean	78.9	30.3	54.7	< 0.001
n	307	305	612
SD	29.88	24.18	36.49
Median	78	25.0	45.0
IQR	60–96	20–32	24–80.5
Minimum	0	0	0
Maximum	211	216	216
Missing	2	6	8
Additional theatre^a procedure
Time from primary procedure to additional procedure in theatre (days)
Mean	4.9	10.4	8.2	0.009
n	15	23	38
SD	1.99	11.11	9.08
Median	5.0	7.0	6.0
IQR	3–6	5–12.4	4–9
Minimum	2	1	1
Maximum	8.4	56.9	56.9
Missing	0	0	0
Time from entry into anaesthetic room to start time in theatre (minutes)
Mean	33.3	29.0	30.7	0.419
n	15	23	38
SD	12.27	17.83	15.83
Median	33	22.0	27.5
IQR	20–45	15–42	19–43
Minimum	15	4	4
Maximum	50	62	62
Missing	0	0	0
Time from start to end of procedure in theatre (minutes)
Mean	79.7	76.3	77.6	0.530
n	15	23	38
SD	36.42	46.83	42.52
Median	80.0	70.0	77.5
IQR	56–94	44–90	50–90
Minimum	21	18	18
Maximum	180	225	225
Missing	0	0	0
Theatre/hospital discharge
Time from theatre to hospital discharge
Mean	5.3	5.9	5.6	0.021
n	309	304	613
SD	5.84	9.17	7.68
Median	3.0	2.5	3.0
IQR	2–6.4	1–7	1–7
Minimum	0	0	0
Maximum	39.9	74.3	74.3
Missing	0	7	7
Hospital discharge/hospital readmission
Time from hospital discharge to readmission (days)
Mean	62.4	46.8	51.7	0.054
n	32	70	102
SD	54.22	51.36	52.51
Median	44.7	14.7	26.2
IQR	17.2–101	9–75.9	10–95.3
Minimum	1	4	1
Maximum	161.2	174.6	174.6
Missing	0	0	0

: IQR, interquartile range.
a: Here ‘n’ is the number of additional theatre procedures/readmissions where a patient can have more than one additional procedure/readmission.

TABLE 60

Summary of the duration from randomisation and injury to the date allocated treatment received (ITT)

Time between events	Treatment group		p-value
Time between events	ORIF	CCC	p-value
Time from injury to allocated treatment received (days)
Mean	5.2	4.8	0.186
n	302	277
SD	3.73	3.26
Median	5	4
IQR	2–7	2–7
Minimum	0	0
Maximum	27	18
Missing	7	34
Time from randomisation to allocated treatment received (days)
Mean	2.4	2.0	0.326
n	302	277
SD	2.97	2.10
Median	1	2
IQR	0–4	0–3
Minimum	0	0
Maximum	26	10
Missing	7	34

: IQR, interquartile range.

TABLE 61

Summary of reported adverse events (ITT)

Complication type	Treatment group
	ORIF (n = 309)			CCC (n = 311)
	Number of participants experiencing an event once (%)	Number of participants experiencing an event twice (%)	Absolute number of events	Number of participants experiencing an event once (%)	Number of participants experiencing an event twice (%)	Absolute number of events
Interoperative fracture	1 (0.3)	0	1	0	0	0
Imperfect reduction reported	0	0	0	4 (1.3)	0	4
Compartment syndrome	0	0	0	0	0	0
Vascular injury	1 (0.3)	0	1	1 (0.3)	0	1
Nerve palsy	2 (0.6)	0	2	2 (0.6)	0	2
Wound breakdown	20 (6.5)	1 (0.3)	22	5 (1.6)	0	5
Infection	7 (2.3)	1 (0.3)	9	2 (0.6)	0	2
Septicaemia	0	0	0	0	0	0
Other clinical issue with wound (not breakdown or infection)	6 (1.9)	0	6	1 (0.3)	0	1
Clinical issue with metalwork	4 (1.3)	0	4	0	0	0
Implant failure	5 (1.6)	0	5	0	0	0
Non-wound skin problem	13 (4.2)	0	13	12 (3.9)	0	12
Pain from cast	12 (3.9)	0	12	16 (5.1)	0	16
Plaster sore	15 (4.9)	0	15	22 (7.1)	0	22
Plaster saw laceration	1 (0.3)	0	1	5 (1.6)	0	5
DVT	3 (1.0)	0	3	6 (1.9)	0	6
PE	1 (0.3)	0	1	6 (1.9)	0	6
Refracture of ankle	0	0	0	0	0	0
Fall postoperatively	3 (1.0)	0	3	4 (1.3)	0	4
Other fracture sustained	1 (0.3)	0	1	0	0	0
Poor bone quality encountered	4 (1.3)	0	4	0	0	0
Poor skin condition encountered	3 (1.0)	0	3	6 (1.9)	0	6
Non-union	0	0	0	2 (0.6)	0	2

TABLE 62

Summary of the additional procedures in theatre (ITT)

Complication type	Treatment group
	ORIF (n = 309)			CCC (n = 311)
	Number of participants experiencing an event once (%)	Number of participants experiencing an event twice (%)	Absolute number of events	Number of participants experiencing an event once (%)	Number of participants experiencing an event twice (%)	Absolute number of events
Remanipulation and traditional cast	1 (0.3)	0	1	0	0	0
Convert to external fixation	0	0	0	0	0	0
Convert to retrograde nail	0	0	0	0	0	0
Revision of ORIF	3 (1.0)	0	3	1 (0.3)	0	1
Wound washout	2 (0.7)	0	2	1 (0.3)	0	1
Delayed wound closure	0	0	0	0	0	0
Wound debridement	1 (0.3)	0	1	0	0	0
Incision and drainage of haematoma	1 (0.3)	0	1	0	0	0
Amputation	0	0	0	0	0	0
Removal of syndesmotic screws	6 (1.9)	0	6	1 (0.3)	0	1
Removal of other metalwork
Because of infection	1 (0.3)	1 (0.3)	3	0	0	0
With washout	0	0	0	2 (0.6)	0	2
Because of pain	0	0	0	0	0	0
Because of poor position of implant	1 (0.3)	0	1	0	0	0
Other reason	1 (0.3)	0	1	0	0	0

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