Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery
- Conditions
- Unequal Length of Limbs; CongenitalLower Extremity Deformities, Congenital
- Interventions
- Drug: saline injection
- Registration Number
- NCT00412035
- Lead Sponsor
- Shriners Hospitals for Children
- 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 discrepancy or angular deformity undergoing limb lengthening or deformity correction.
- 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 taken in the postoperative period.
* 2. Improve the quality of life during the distraction and consolidation process.
* 3 Decrease muscular spasm and subsequent muscle contracture during the distraction and consolidation process and accelerate earlier return to pre-operative mobility function including earlier weight bearing.
* 4. To develop clinical practice guidelines for the interdisciplinary care of children undergoing limb lengthening or deformity correction.
Methodology: A randomization process for this one time injection will be used to determine who will receive the BTX-A or the placebo. 150 subjects will be recruited; 75 to the BTX-A group and 75 to the placebo group. There will be an equal number of subjects in each group at each site. The medication will be injected intraoperatively into specific major muscles in the lower limb adjacent to the bone or soft tissue being lengthened or corrected at a dose of 10 U/kg with a maximum of 50 U per site, not to exceed a total maximum dose of 400 units. Pain scores, medication dosages, range of motion and an ambulation scale will be measured post-operatively and during the distraction and consolidation phases.
In addition families will be asked to complete six different questionnaires related to pain, quality of life and psycho-social issues at various times during the process. The children will receive standard nursing care and physical therapy and will be followed for three months after the external fixator is removed, for a total time of approximately one year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Botox Botulinum toxin A injection Botulinum toxin A injection Placebo saline injection saline injection
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Quality of life (PedsQL) pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal Active and passive range of motion pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal Muscle strength pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal Ambulation scores (FAQ) pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
Trial Locations
- Locations (3)
Alfred I.duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Shriners Hospital for Children
🇨🇦Montreal, Quebec, Canada