TABLE III.
Secondary Outcomes by Treatment Type
| Secondary Outcomes | Intramedullary Nailing | External Fixation | Difference (95% CI) | P Value for Adjusted Analysis | |||
| Mean and Standard Deviation | No. of Patients | Mean and Standard Deviation | No. of Patients | Unadjusted* | Adjusted† | ||
| EQ-5D-3L index‡ | |||||||
| At 2 wk | 0.59 ± 0.11 | 83 | 0.59 ± 0.09 | 84 | −0.01 (−0.01 to 0.00) | 0.00 (−0.04 to 0.03) | 0.829 |
| At 6 wk | 0.65 ± 0.11 | 86 | 0.58 ± 0.17 | 84 | 0.07 (0.05 to 0.08) | 0.07 (0.03 to 0.11) | <0.001 |
| At 12 wk | 0.69 ± 0.15 | 76 | 0.66 ± 0.16 | 84 | 0.03 (0.03 to 0.03) | 0.03 (−0.01 to 0.07) | 0.118 |
| At 26 wk | 0.78 ± 0.18 | 71 | 0.74 ± 0.22 | 64 | 0.04 (0.03 to 0.05) | 0.04 (−0.02 to 0.10) | 0.195 |
| At 52 wk | 0.90 ± 0.12 | 106 | 0.91 ± 0.12 | 98 | −0.01 (−0.01 to −0.01) | −0.01 (−0.02 to 0.02) | 0.542 |
| EQ-VAS§ | |||||||
| At 2 wk | 58.8 ± 13.0 | 81 | 57.9 ± 11.5 | 84 | 0.9 (0.5 to 1.3) | 1.0 (−2.3 to 4.3) | 0.561 |
| At 6 wk | 67.7 ± 13.9 | 86 | 62.7 ± 13.3 | 85 | 5.0 (4.9 to 5.1) | 4.7 (1.7 to 7.8) | 0.002 |
| At 12 wk | 76.7 ± 14.9 | 76 | 72.6 ± 13.5 | 84 | 4.1 (3.4 to 4.5) | 3.4 (−0.4 to 7.2) | 0.076 |
| At 26 wk | 83.1 ± 13.0 | 71 | 80.2 ± 12.4 | 64 | 2.9 (2.8 to 2.9) | 2.5 (−0.4 to 5.5) | 0.096 |
| At 52 wk | 91.2 ± 9.6 | 107 | 90.7 ± 9.3 | 100 | 0.5 (0.5 to 0.5) | 0.5 (−1.9 to 2.8) | 0.695 |
| mRUST# | |||||||
| At 6 wk | 6.8 ± 2.0 | 61 | 5.6 ± 1.8 | 66 | 1.3 (1.2 to 1.3) | 1.2 (0.4 to 2.0) | 0.005 |
| At 12 wk | 8.9 ± 2.6 | 63 | 7.7 ± 2.2 | 73 | 1.2 (1.0 to 1.3) | 1.0 (0.3 to 1.7) | 0.005 |
| At 26 wk | 11.3 ± 2.3 | 56 | 10.8 ± 2.1 | 59 | 0.4 (0.4 to 0.5) | 0.4 (−0.2 to 1.1) | 0.207 |
| At 52 wk | 13.0 ± 3.0 | 93 | 12.1 ± 3.5 | 92 | 0.9 (0.8 to 1.0) | 0.8 (0.2 to 1.5) | 0.013 |
The values are calculated as the mean value for the intramedullary nailing group minus the mean value for the external fixation group. A positive score indicates that treatment favors intramedullary nailing.
Linear mixed-effects regression model of complete-case data with a time-by-treatment interaction as a fixed effect and patient as the random intercept.
The EQ-5D-3L index measures health-related quality of life on the basis of a descriptive system, with 0 indicating death and 1 indicating perfect health. The minimum clinically important difference is 0.08 point.
The EQ-VAS measures health-related quality of life on a visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
The mRUST quantifies radiographic fracture-healing, with a possible range of 4 to 16.