Status:
COMPLETED
Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery
Lead Sponsor:
Shriners Hospitals for Children
Conditions:
Unequal Length of Limbs; Congenital
Lower Extremity Deformities, Congenital
Eligibility:
All Genders
5-21 years
Phase:
PHASE3
Brief 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 disc...
Detailed Description
The specific aims are to determine if BTX-A will: * 1a. Reduce pain post operatively and during the distraction and consolidation process, * 1b. Reduce the amount, frequency and duration of narcotics...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00412035
Start Date
January 1 2007
End Date
December 1 2012
Last Update
December 23 2014
Active Locations (6)
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1
Alfred I.duPont Hospital for Children
Wilmington, Delaware, United States, 19899
2
Shriners Hospital for Children
Honolulu, Hawaii, United States, 96826-1099
3
Shriners Hospital for Children
Portland, Oregon, United States, 97239-3095
4
Shriners Hospital for Children
Philadelphia, Pennsylvania, United States, 19140