Robert Jay Cummings1. 1. Department of Orthopaedics, Nemours Children's Clinic, Jacksonville, FL 32207, USA. jcumming@nemours.org
Abstract
BACKGROUND: The Ponseti method has been shown to be a highly effective way to correct congenital clubfeet nonoperatively. Children treated with the technique frequently require percutaneous Achilles tenotomies, however, and until recently have experienced frequent relapses of their deformity. The purpose of this study was to see if Botulinum a A toxin (BTX-A) (manufactured by Allergan, Irvine CA) and administered before starting treatment with the Ponseti method might decrease the time in cast to correction, reduce the need for percutaneous Achilles tenotomy, and reduce the frequency of relapse. METHODS: After IRB approval and informed consent, 20 newborns (age 0 to 30 d) with Dimeglio lll congenital clubfeet (N=32) were randomized into either BTX-A or placebo groups. All clubfeet underwent serial manipulation and casting according to the Ponseti technique. Outcomes measured were days in cast to correction of deformity (judged clinically and radiographically), and the need for percutaneous Achilles tenotomy to achieve correction. Recurrence requiring further treatment after initial correction was also recorded. RESULTS: We were unable to demonstrate a significant difference (t test and chi2 procedures) between the BTX-a group and the placebo group in the outcomes measured. CONCLUSIONS: We were not able to demonstrate that BTX-A as administered in this study speeds correction, reduces the need for percutaneous Achilles tenotomy, or decreases the chance of relapse after treatment when used as an adjunct to serial manipulation and casting for congenital clubfoot. It is possible that BTX-A could have a treatment effect that due to the power of our study would not have been detected by our study. LEVEL OF EVIDENCE: Level 1b.
RCT Entities:
BACKGROUND: The Ponseti method has been shown to be a highly effective way to correct congenital clubfeet nonoperatively. Children treated with the technique frequently require percutaneous Achilles tenotomies, however, and until recently have experienced frequent relapses of their deformity. The purpose of this study was to see if Botulinum a A toxin (BTX-A) (manufactured by Allergan, Irvine CA) and administered before starting treatment with the Ponseti method might decrease the time in cast to correction, reduce the need for percutaneous Achilles tenotomy, and reduce the frequency of relapse. METHODS: After IRB approval and informed consent, 20 newborns (age 0 to 30 d) with Dimeglio lll congenital clubfeet (N=32) were randomized into either BTX-A or placebo groups. All clubfeet underwent serial manipulation and casting according to the Ponseti technique. Outcomes measured were days in cast to correction of deformity (judged clinically and radiographically), and the need for percutaneous Achilles tenotomy to achieve correction. Recurrence requiring further treatment after initial correction was also recorded. RESULTS: We were unable to demonstrate a significant difference (t test and chi2 procedures) between the BTX-a group and the placebo group in the outcomes measured. CONCLUSIONS: We were not able to demonstrate that BTX-A as administered in this study speeds correction, reduces the need for percutaneous Achilles tenotomy, or decreases the chance of relapse after treatment when used as an adjunct to serial manipulation and casting for congenital clubfoot. It is possible that BTX-A could have a treatment effect that due to the power of our study would not have been detected by our study. LEVEL OF EVIDENCE: Level 1b.