Clinical trial NCT00412035: Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Unequal Length of Limbs; Congenital
Lower Extremity Deformities, Congenital
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2006-12-15
Enrollment: 125
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: average pain scores in 1st 4 days post op
timeFrame: 1st 4 days post op
measure: total amount of narcotic used in 1st 4 days post op
timeFrame: 1st 4 days post op
Secondary outcomes:
measure: Quality of life (PedsQL)
timeFrame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
measure: Active and passive range of motion
timeFrame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
measure: Muscle strength
timeFrame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
measure: Ambulation scores (FAQ)
timeFrame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Alfred I.duPont Hospital for Children
state: Delaware
city: Honolulu
country: United States
facility: Shriners Hospital for Children
state: Hawaii
city: Portland
country: United States
facility: Shriners Hospital for Children
state: Oregon
city: Philadelphia
country: United States
facility: Shriners Hospital for Children
state: Pennsylvania
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Shriners Hospital for Children
state: Quebec
Study officials:
affiliation: Shriners Hospital for Children-Canadian Unit, Montreal, Quebec
name: Reggie Hamdy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.