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.
TABLE 47
Summary of SF-12 and EQ-5D outcomes at the 6-week and 6-month assessments (ITT)
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Outcome | Treatment group | Unadjusted statistics (95% CI); p-value | Adjusted statistics (95% CI); p-value |
---|
ORIF | CCC |
---|
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)
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Timed up and go test (seconds) | Treatment group | p-valuea |
---|
ORIF | CCC |
---|
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)
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Additional timed up and go walking test details | Treatment group | p-value |
---|
ORIF, n (%) | CCC, n (%) |
---|
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)
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Range of ankle motion | Treatment group | Unadjusted statistics (95% CI); p-value | Adjusted statistics (95% CI); p-value |
---|
ORIF | CCC |
---|
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)
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Pain outcomes | Treatment group | Unadjusted odds ratio (95% CI); p-value | Adjusted odds ratio (95% CI); p-value |
---|
ORIF, n (%) | CCC, n (%) |
---|
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)
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Patient satisfaction | Treatment group | Unadjusted odds ratio (95% CI); p-value | Adjusted odds ratio (95% CI); p-value |
---|
ORIF, n (%) | CCC, n (%) |
---|
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)
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Malunion typea | Treatment group | Total (N = 556), n (%) |
---|
ORIF (N = 281), n (%) | CCC (N = 275), 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)
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Radiological assessment | Treatment group | p-value |
---|
ORIF (N = 281), n (%) | CCC (N = 275), n (%) |
---|
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)
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Radiological assessment | Treatment group | p-value |
---|
ORIF (N = 281), n (%) | CCC (N = 274), n (%) |
---|
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)
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OMAS | Treatment group | Unadjusted odds ratio (95% CI); p-value | Adjusted odds ratio (95% CI); p-valuea |
---|
ORIF, n (%) | CCC, n (%) |
---|
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)
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Treatment received | Blinded assessors guess | Total | James’ Blinding Index (95% CI) |
---|
CCC | ORIF | Don’t know |
---|
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)
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Event | Number of participants experiencing an event, n (%) | Unadjusted analysis | Adjusted analysis |
---|
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)
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Process variable | Treatment group | Total | p-value |
---|
ORIF | CCC |
---|
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 theatrea 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)
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Time between events | Treatment group | p-value |
---|
ORIF | CCC |
---|
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)
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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)
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Complication type | Treatment group |
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ORIF (n = 309) | CCC (n = 311) |
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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 |
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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 |
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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 |