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

• ClinicalTrials.gov Identifier: NCT00412035
• Recruitment Status: Completed
• First Posted: December 15, 2006
• Last Update Posted: December 23, 2014
• Sponsor: Shriners Hospitals for Children
• Information provided by (Responsible Party): Reggie Hamdy, MD, Shriners Hospitals for Children

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Unequal Length of Limbs; Congenital; Lower Extremity Deformities, Congenital	Drug: Botulinum toxin A injection; Drug: saline injection	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: January 2007
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

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 Name: botox
Placebo Comparator: Placebo; saline injection	Drug: saline injection; 10 units per kilo to maximum of 400 units; Other Name: salt water

Outcome Measures

Primary Outcome Measures :

1. average pain scores in 1st 4 days post op [ Time Frame: 1st 4 days post op ]
2. total amount of narcotic used in 1st 4 days post op [ Time Frame: 1st 4 days post op ]

Secondary Outcome Measures :

1. Quality of life (PedsQL) [ Time Frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal ]
2. Active and passive range of motion [ Time Frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal ]
3. Muscle strength [ Time Frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal ]
4. Ambulation scores (FAQ) [ Time Frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal ]

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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 of Results:

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.

Other 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.

• Responsible Party: Reggie Hamdy, MD, Principal Investigator, Shriners Hospitals for Children
• ClinicalTrials.gov Identifier: NCT00412035
• Other Study ID Numbers: 9142
• First Posted: December 15, 2006
• Last Update Posted: December 23, 2014
• Last Verified: December 2014

Additional relevant MeSH terms:

Lower Extremity Deformities, Congenital; Congenital Abnormalities; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents