Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery

NCT00412035 | Completed Phase 3 DMC

• 1 other identifier: 9142
• Study Type: interventional
• Target: 125
• Locations: 2 countries
• Sites: 6

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Botox

ACTIVE COMPARATOR

Botulinum toxin A injection

Drug: Botulinum toxin A injection

Placebo

PLACEBO COMPARATOR

saline injection

Drug: saline injection

Interventions

Botulinum toxin A injection DRUG

10 units per kilo to maximum of 400 units

Also known as: botox

Botox

saline injection DRUG

10 units per kilo to maximum of 400 units

Also known as: salt water

Placebo

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shriners Hospitals for Children: lead

Study Sites (6)

Alfred I.duPont Hospital for Children

Wilmington, Delaware, 19899, United States

Location

Shriners Hospital for Children

Honolulu, Hawaii, 96826-1099, United States

Location

Shriners Hospital for Children

Portland, Oregon, 97239-3095, United States

Location

Shriners Hospital for Children

Philadelphia, Pennsylvania, 19140, United States

Location

The Hospital for Sick Children

Toronto, Ontario, M5g 1X8, Canada

Location

Shriners Hospital for Children

Montreal, Quebec, H3G 1A6, Canada

Location

Related Publications (3)

• 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.

  PMID: 17903262 BACKGROUND

• 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.

  PMID: 19934710 BACKGROUND

• 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.

  PMID: 19568011 RESULT

MeSH Terms

Conditions

Lower Extremity Deformities, Congenital

Interventions

Botulinum Toxins, Type A; Sodium Chloride; Fluoridation

Condition Hierarchy (Ancestors)

Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health

Study Officials

• Reggie Hamdy, MD

  Shriners Hospital for Children-Canadian Unit, Montreal, Quebec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2006
• First Posted: December 15, 2006
• Study Start: January 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

CA (2); US (4)