TABLE II.

Study Outcomes by Treatment Type

Outcome	Total* (N = 221)	Intramedullary Nailing* (N = 111)	External Fixator* (N = 110)	Relative Risk (95% CI)	P Value
Primary outcome	44 (19.9%)	20 (18.0%)	24 (21.8%)	0.83 (0.49 to 1.41)	0.505
Reoperation for deep infection	28 (12.7%)	15 (13.5%)	13 (11.8%)	1.14 (0.57 to 2.29)	0.840
Reoperation for nonunion	11 (5.0%)	3 (2.7%)	8 (7.3%)	0.37 (0.10 to 1.36)	0.135
Reoperation for malalignment	2 (0.9%)	1 (0.9%)	1 (0.9%)	0.99 (0.06 to 15.65)	1.000
Death	3 (1.4%)	1 (0.9%)	2 (1.8%)	0.50 (0.05 to 5.39)	0.622
Secondary events	28 (12.7%)	13 (11.7%)	15 (13.6%)	0.86 (0.43 to 1.72)	0.691
Superficial SSI†	18 (8.1%)	8 (7.2%)	10 (9.1%)	0.79 (0.33 to 1.93)	0.632
Delayed wound-healing	10 (4.5%)	5 (4.5%)	5 (4.5%)	0.99 (0.30 to 3.33)	1.000
Coronal malalignment >10°	10 (4.5%)‡	1 (0.9%)	9 (8.2%)	0.11 (0.01 to 0.85)	0.010
Sagittal malalignment >10°	7 (3.2%)‡	1 (0.9%)	6 (5.5%)	0.17 (0.02 to 1.35)	0.065
Secondary outcomes§
EQ-5D-3L index#	0.91 ± 0.1	0.90 ± 0.1	0.91 ± 0.1	—	0.634
EQ-VAS**	90.9 ± 9.4	91.2 ± 9.6	90.7 ± 9.3	—	0.711
mRUST††	12.5 ± 3.3	13.0 ± 3.0	12.1 ± 3.5	—	0.058

^*The data are given as the mean and the standard deviation or as the number of patients, with the percentage in parentheses.

^†Pin-site infections were not included as superficial surgical site infections (SSIs).

^‡Thirteen individuals had malalignment at 1 year, of whom 4 had biplanar deformity.

^§Secondary outcomes were compared between treatment groups at 1 year with use of the Student t test.

^#The EQ-5D-3L index measures health-related quality of life.

^**VAS = visual analog scale.

^††mRUST = modified Radiographic Union Scale for Tibial fractures.