Hard-soled shoe was noninferior to short leg cast for avulsion fractures
Published results showed weight-bearing as tolerated in a hard-soled shoe was noninferior to use of a short leg cast for treatment of fifth metatarsal base avulsion fractures.
Noninferiority studies aim to demonstrate that the test product is not worse than the comparator by more than a small prespecified amount.
In their study, Young Rak Choi, MD, and his colleagues randomly assigned 96 patients with a fifth metatarsal base avulsion fracture to receive treatment with either a hard-soled shoe (n=46) or a short leg cast (n=50). Researchers considered the mean difference on the 100-mm VAS between the groups at 6 months after fracture as the primary outcome measure. Time to return to preinjury activity and patient-reported satisfaction were the secondary outcome measures. Researchers performed the analysis on an intention-to-treat basis, as well as a per-protocol basis.
Intention-to-treat analysis results showed a mean 100-mm VAS of approximately 8.6 mm in the hard-soled shoe group and 9.8 mm in the short leg cast group at 6 months after fracture. The mean difference between the two groups for 100-mm VAS was –1.3 mm.
Researchers found treatment with a hard-soled shoe was noninferior to treatment with a short leg cast, with the noninferiority margin of 10 mm not exceeded by the upper limit of the 95% confidence interval.
Both the intention-to-treat and per-protocol analyses showed patients in the hard-soled shoe group experienced a significantly shorter time to return to preinjury activity. Although patients in the hard-soled shoe group had significantly higher Olerud-Molander scores at the 4-week follow-up, researchers noted the differences in these scores between the two groups were not significant at the 8-week, 12-week and 6-month follow-up visits.
Results showed 89.5% of patients in the hard-soled shoe group and 87.5% of patients in the short leg cast group reported being either very satisfied or satisfied with their treatment. In the results, researchers reported no cases of fracture nonunion in either group.
“In the present study, the hard-soled shoe group had no cases of nonunion after initiation of tolerated weight-bearing, and had an earlier return to preinjury activity compared with the short leg cast group. The degree of displacement or comminution did not preclude recruitment into this trial,” the authors wrote. “With satisfactory clinical outcomes without nonunion, it may be reasonable to suggest that nonoperative treatment provides acceptable outcomes even for a displaced comminuted fracture.”
- For more information:
- Young Rak Choi, MD, can be reached at Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea; email: firstname.lastname@example.org.