CompletedPhase 3

Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery

United States, Canada125 participantsStarted 2007-01

Plain-language 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.

Who can participate

Age range5 Years – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

average pain scores in 1st 4 days post op

Timeframe: 1st 4 days post op

total amount of narcotic used in 1st 4 days post op

Timeframe: 1st 4 days post op

Trial details

NCT IDNCT00412035

SponsorShriners Hospitals for Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

View on ClinicalTrials.gov More Unequal Length of Limbs; Congenital trials