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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Lower Limb Length Discrepancy
Lower Limb Angular Deformity
 Drug: Botulinum toxin A injection
Drug: saline injection
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Botox Injection in Alleviating Post-Operative Pain and Improving Quality of Life in Lower Extremity Limb Lengthening and Deformity Correction

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: January 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Botulinum toxin A injection
 Drug: Botulinum toxin A injection
10 units per kilo to maximum of 400 units
Other Name: botox
Placebo Comparator: 2
saline injection
 Drug: saline injection
10 units per kilo to maximum of 400 units
Other Name: salt water

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.

  Eligibility

Ages Eligible for Study:   5 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412035

Contacts
Contact: Reggie Hamdy, MD 514-282-7150 rhamdy@shriners.mcgill.ca
Contact: Kathleen Montpetit, MScOT 514-282-6962 kmontpetit@shrinenet.org

Locations
United States, Delaware
Alfred I.duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19899
Contact: Aaron Littleton     302-651-5906     aalittle@nemours.org    
Contact: William MacKenzie, MD     (302) 651-4000     wmackenz@nemours.org    
Principal Investigator: William MacKenzie, MD            
United States, Hawaii
Shriners Hospital for Children Recruiting
Honolulu, Hawaii, United States, 96826-1099
Contact: Ramona Fillman     808-951-3693     rfillman@shrinenet.org    
Contact: Ellen Raney, MD     (808) 951-3640     eraney@shrinenet.org    
Principal Investigator: Ellen Raney, MD            
United States, Oregon
Shriners Hospital for Children Recruiting
Portland, Oregon, United States, 97239-3095
Contact: Susan Sienko     503-221-3481     sst@shcc.org    
Contact: Michael Aiona, MD     (503) 221-3424     maiona@shrinenet.org    
Principal Investigator: Michael Aiona, MD            
United States, Pennsylvania
Shriners Hospital for Children Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Ross Chafetz, MPH     215-430-4114     rchafetz@shrinenet.org    
Contact: James McCarthy, MD     (215) 430-4022     jmccarthy@shrinenet.org    
Principal Investigator: James McCarthy, MD            
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5g 1X8
Contact: Shannon Weir     416-813-6608     shannon.weir@sickkids.ca    
Contact: Unni Narayanan, MD     (416) 813-6432     unni.narayanan@sickkids.ca    
Principal Investigator: Unni Narayanan, MD            
Canada, Quebec
Shriners Hospital for Children Recruiting
Montreal, Quebec, Canada, H3G 1A6
Contact: Kathleen Montpetit, MScOT     514-282-6962     kmontpetit@shrinenet.org    
Contact: Reggie Hamdy, MD     514-282-7150     rhamdy@shriners.mcgill.ca    
Principal Investigator: Reggie Hamdy, MD            
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Principal Investigator: Reggie Hamdy, MD Shriners Hospital for Children-Canadian Unit, Montreal, Quebec
  More Information

Publications:

Responsible Party: Michael Aiona, MD, Shriners Hospital for Children Portland
ClinicalTrials.gov Identifier: NCT00412035     History of Changes
Other Study ID Numbers: 9055
Study First Received: December 13, 2006
Last Updated: June 11, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Congenital Abnormalities
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013