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Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery

NCT00412035 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2014-12-23

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Botulinum toxin A injection

10 units per kilo to maximum of 400 units

DRUG

saline injection

10 units per kilo to maximum of 400 units

Sponsors & Collaborators

  • Shriners Hospitals for Children

    lead OTHER

Principal Investigators

  • Reggie Hamdy, MD · Shriners Hospital for Children-Canadian Unit, Montreal, Quebec

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00412035 on ClinicalTrials.gov