Trial record 1 of 1 for:    Safety and Efficacy of BOTOX Injection in Alleviating Pain and Improving Quality of Life in Lower Extremity Lengthening
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Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery (BOLLD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Shriners Hospitals for Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00412035
First received: December 13, 2006
Last updated: June 11, 2008
Last verified: June 2008

December 13, 2006
June 11, 2008
January 2007
December 2009   (final data collection date for primary outcome measure)
  • average pain scores in 1st 4 days post op [ Time Frame: 1st 4 days post op ] [ Designated as safety issue: No ]
  • total amount of narcotic used in 1st 4 days post op [ Time Frame: 1st 4 days post op ] [ Designated as safety issue: No ]
  • average pain scores in 1st 4 days post op
  • total amount of narcotic used in 1st 4 days post op
Complete list of historical versions of study NCT00412035 on ClinicalTrials.gov Archive Site
  • Quality of life (PedsQL) [ Time Frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal ] [ Designated as safety issue: No ]
  • Active and passive range of motion [ Time Frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal ] [ Designated as safety issue: No ]
  • Muscle strength [ Time Frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal ] [ Designated as safety issue: No ]
  • Ambulation scores (FAQ) [ Time Frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal ] [ Designated as safety issue: No ]
  • Quality of life (PedsQL)
  • Active and passive range of motion
  • Muscle strength
  • Ambulation scores (FAQ)
  • Impact on family scores
Not Provided
Not Provided
 
Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery
Safety and Efficacy of Botox Injection in Alleviating Post-Operative Pain and Improving Quality of Life in Lower Extremity Limb Lengthening and Deformity Correction

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Lower Limb Length Discrepancy
  • Lower Limb Angular Deformity
  • Drug: Botulinum toxin A injection
    10 units per kilo to maximum of 400 units
    Other Name: botox
  • Drug: saline injection
    10 units per kilo to maximum of 400 units
    Other Name: salt water
  • Active Comparator: 1
    Botulinum toxin A injection
    Intervention: Drug: Botulinum toxin A injection
  • Placebo Comparator: 2
    saline injection
    Intervention: Drug: saline injection
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
5 Years to 21 Years
No
Contact: Reggie Hamdy, MD 514-282-7150 rhamdy@shriners.mcgill.ca
Contact: Kathleen Montpetit, MScOT 514-282-6962 kmontpetit@shrinenet.org
United States,   Canada
 
NCT00412035
9055
Not Provided
Michael Aiona, MD, Shriners Hospital for Children Portland
Shriners Hospitals for Children
Not Provided
Principal Investigator: Reggie Hamdy, MD Shriners Hospital for Children-Canadian Unit, Montreal, Quebec
Shriners Hospitals for Children
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP