Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery
NCT ID: NCT00412035
Last Updated: 2014-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
125 participants
INTERVENTIONAL
2007-01-31
2012-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Botox
Botulinum toxin A injection
Botulinum toxin A injection
10 units per kilo to maximum of 400 units
Placebo
saline injection
saline injection
10 units per kilo to maximum of 400 units
Interventions
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Botulinum toxin A injection
10 units per kilo to maximum of 400 units
saline injection
10 units per kilo to maximum of 400 units
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Associated neuromuscular conditions that may hinder weight bearing.
* Individuals on aminoglycosides, as aminoglycosides can potentiate the effect of Botulinum toxin A.
5 Years
21 Years
ALL
No
Sponsors
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Shriners Hospitals for Children
OTHER
Responsible Party
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Reggie Hamdy, MD
Principal Investigator
Principal Investigators
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Reggie Hamdy, MD
Role: PRINCIPAL_INVESTIGATOR
Shriners Hospital for Children-Canadian Unit, Montreal, Quebec
Locations
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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
Countries
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References
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Hamdy RC, Montpetit K, Ruck-Gibis J, Thorstad K, Raney E, Aiona M, Platt R, Finley A, Mackenzie W, McCarthy J, Narayanan U. Safety and efficacy of botox injection in alleviating post-operative pain and improving quality of life in lower extremity limb lengthening and deformity correction. Trials. 2007 Sep 28;8:27. doi: 10.1186/1745-6215-8-27.
Montpetit K, Hamdy RC, Dahan-Oliel N, Zhang X, Narayanan UG. Measurement of health-related quality of life in children undergoing external fixator treatment for lower limb deformities. J Pediatr Orthop. 2009 Dec;29(8):920-6. doi: 10.1097/BPO.0b013e3181c1e2e2.
Hamdy RC, Montpetit K, Raney EM, Aiona MD, Fillman RR, MacKenzie W, McCarthy J, Chafetz RS, Thomas SS, Tamayo CM, Littleton AG, Ruck-Gibis J, Takahashi SN, Rinaldi M, Finley GA, Platt RW, Dahan-Oliel N. Botulinum toxin type A injection in alleviating postoperative pain and improving quality of life in lower extremity limb lengthening and deformity correction: a pilot study. J Pediatr Orthop. 2009 Jul-Aug;29(5):427-34. doi: 10.1097/BPO.0b013e3181aad628.
Other Identifiers
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9142
Identifier Type: -
Identifier Source: org_study_id