Hard-Soled Shoe Versus Short Leg Cast for a Fifth Metatarsal Base Avulsion Fracture A Multicenter, Noninferiority, Randomized Controlled Trial

초록

Background: The purpose of this study was to determine whether tolerated weight-bearing in a hard-soled shoe was noninferior to the use of a short leg cast for the treatment of a fifth metatarsal base avulsion fracture, as assessed with use of a 100-mm visual analog scale (VAS) for pain at 6 months after the fracture. Methods: A total of 145 patients were assessed for eligibility. Of these, 96 patients were randomly assigned to either the hard-soled shoe group (46 patients) or the cast group (50 patients). The primary outcome measure was the mean difference on the 100-mm VAS between groups at 6 months after the fracture. Secondary outcome measures included the time to return to preinjury activity and patient-reported satisfaction. Analysis was performed according to both an intention-to-treat basis (i.e., patients were included in the assessment of their assigned treatment arm, even if they crossed over to the other treatment arm prior to completing the 6-month follow-up) and a per-protocol basis (i.e., patients who completed the 6-month follow-up were analyzed according to the treatment they received). Results: At 6 months after the fracture, the mean 100-mm VAS was 8.6 +/- 7.0 mm in the hard-soled shoe group and 9.8 +/- 7.3 mm in the cast group (p = 0.41) according to intention-to-treat analysis. The mean difference in 100-mm VAS between the 2 groups was -1.3 mm (95% confidence interval, -4.3 to 1.8 mm). The upper limit of the 95% confidence interval did not exceed the noninferiority margin of 10 mm, indicating that treatment with the hard-soled shoe was noninferior to treatment with the short leg cast. The proportion of patients who reported satisfaction with their treatment was similar between the hard-soled shoe and cast groups (89.5% compared with 87.5%, respectively; p = 0.79), but the time to return to preinjury activity was significantly shorter in the hard-soled shoe group (37.2 +/- 14.4 days compared with 43.0 +/- 11.1 days in the cast group; p = 0.04). There were no cases of nonunion in either group. Conclusions: Weight-bearing as tolerated in a hard-soled shoe for a fifth metatarsal base avulsion fracture was noninferior to the use of a short leg cast as assessed with use of a 100-mm VAS at 6 months after the fracture. Patient-reported satisfaction was similar between groups, but the time to return to preinjury activity was shorter in the hard-soled shoe group.