Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery

Lower Extremity Deformities, Congenital Clinical Trial

— BOLLD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412035
• Other study ID #: 9142
• Status: Completed
• Phase: Phase 3
• First received: December 13, 2006
• Last updated: December 22, 2014
• Start date: January 2007
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Lower Extremity Deformities, Congenital
• Unequal Length of Limbs; Congenital

Intervention

Drug:
• Botulinum toxin A injection
10 units per kilo to maximum of 400 units
• saline injection
10 units per kilo to maximum of 400 units

Locations

Country	Name	City	State
Canada	Shriners Hospital for Children	Montreal	Quebec
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	Shriners Hospital for Children	Honolulu	Hawaii
United States	Shriners Hospital for Children	Philadelphia	Pennsylvania
United States	Shriners Hospital for Children	Portland	Oregon
United States	Alfred I.duPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

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 post — View 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. — View 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. Erratum in: J Pediatr Orthop. 2010 Dec;30(8):944. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average pain scores in 1st 4 days post op		1st 4 days post op
Primary	total amount of narcotic used in 1st 4 days post op		1st 4 days post op
Secondary	Quality of life (PedsQL)		pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
Secondary	Active and passive range of motion		pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
Secondary	Muscle strength		pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal
Secondary	Ambulation scores (FAQ)		pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal