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

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.

Study Overview

• Status: Completed
• Conditions: Lower Extremity Deformities, Congenital; Unequal Length of Limbs; Congenital
• Intervention / Treatment: Drug: Botulinum toxin A injection; Drug: saline injection

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A6
      • Shriners Hospital for Children
• United States
  • Delaware
    • Wilmington, Delaware, United States, 19899
      • Alfred I.duPont Hospital for Children
  • Hawaii
    • Honolulu, Hawaii, United States, 96826-1099
      • Shriners Hospital for Children
  • Oregon
    • Portland, Oregon, United States, 97239-3095
      • Shriners Hospital for Children
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Shriners Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Botox; Botulinum toxin A injection	Drug: Botulinum toxin A injection; 10 units per kilo to maximum of 400 units; Other Names: botox
PLACEBO_COMPARATOR: Placebo; saline injection	Drug: saline injection; 10 units per kilo to maximum of 400 units; Other Names: salt water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shriners Hospitals for Children
• Investigators: Principal Investigator: Reggie Hamdy, MD, Shriners Hospital for Children-Canadian Unit, Montreal, Quebec

Publications and helpful links

General Publications

• 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. Erratum In: J Pediatr Orthop. 2010 Dec;30(8):944.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: December 13, 2006
• First Submitted That Met QC Criteria: December 13, 2006
• First Posted (ESTIMATE): December 15, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 22, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Congenital Abnormalities; Lower Extremity Deformities, Congenital; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 9142