Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Unequal Length of Limbs; Congenital, Lower Extremity Deformities, Congenital

In brief

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.

Key facts

Study ID

NCT00412035

Run by

Shriners Hospitals for Children

People needed

125

Starts

2007-01-01

Expected to finish

2012-12-01

Last updated by the study team

2014-12-23

Who can join

Age: 5 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alfred I.duPont Hospital for Children — Wilmington, Delaware, United States
• Shriners Hospital for Children — Honolulu, Hawaii, United States
• Shriners Hospital for Children — Portland, Oregon, United States
• Shriners Hospital for Children — Philadelphia, Pennsylvania, United States
• The Hospital for Sick Children — Toronto, Ontario, Canada
• Shriners Hospital for Children — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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