Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this six site multi-center study is to determine if BTX-A can alleviate the post-operative pain and improve the functional and quality of life outcomes of children with limb length discrepancy or angular deformity undergoing limb lengthening or deformity correction.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shriners Hospitals for Children
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Age: 5 to 21 years.

• Aetiology of the deformity: congenital or acquired.

• Amount of lengthening or deformity correction: any amount.

• Site of lengthening or deformity correction: lower extremity.

• Type of fixator: circular or uniplanar.

Exclusion Criteria:

• Children younger than 5 years of age.

• Associated neuromuscular conditions that may hinder weight bearing.

• Individuals on aminoglycosides, as aminoglycosides can potentiate the effect of Botulinum toxin A.