Safety and Efficacy of Botox Injection in Alleviating Post-Operative Pain and Improving Quality of Life in Lower Extremity Limb Lengthening and Deformity Correction (BOLLD)

NCT00412035 Phase 3 COMPLETED

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.

Details

Lead sponsor	Shriners Hospitals for Children
Phase	Phase 3
Status	COMPLETED
Enrolment	125
Start date	2007-01
Completion	2012-12

Conditions

• Unequal Length of Limbs; Congenital
• Lower Extremity Deformities, Congenital

Interventions

• Botulinum toxin A injection
• saline injection

Primary outcomes

• average pain scores in 1st 4 days post op — 1st 4 days post op
• total amount of narcotic used in 1st 4 days post op — 1st 4 days post op

Countries

United States, Canada