Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery (BOLLD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reggie Hamdy, MD, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00412035
First received: December 13, 2006
Last updated: December 22, 2014
Last verified: December 2014
  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
Unequal Length of Limbs; Congenital
Lower Extremity Deformities, Congenital
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:


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 ]

Enrollment: 125
Study Start Date: January 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Botox
Botulinum toxin A injection
Drug: Botulinum toxin A injection
10 units per kilo to maximum of 400 units
Other Name: botox
Placebo Comparator: Placebo
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Delaware
Alfred I.duPont Hospital for Children
Wilmington, Delaware, United States, 19899
United States, Hawaii
Shriners Hospital for Children
Honolulu, Hawaii, United States, 96826-1099
United States, Oregon
Shriners Hospital for Children
Portland, Oregon, United States, 97239-3095
United States, Pennsylvania
Shriners Hospital for Children
Philadelphia, Pennsylvania, United States, 19140
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5g 1X8
Canada, Quebec
Shriners Hospital for Children
Montreal, Quebec, Canada, H3G 1A6
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: Reggie Hamdy, MD, Principal Investigator, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00412035     History of Changes
Other Study ID Numbers: 9142
Study First Received: December 13, 2006
Last Updated: December 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Congenital Abnormalities
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 26, 2015