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| Sponsored by: |
Shriners Hospitals for Children |
|---|---|
| Information provided by: | Shriners Hospitals for Children |
| ClinicalTrials.gov Identifier: | NCT00412035 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lower Limb Length Discrepancy Lower Limb Angular Deformity |
Drug: Botulinum toxin A injection Drug: saline injection |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Botulinum toxin A injection
|
Drug: Botulinum toxin A injection
10 units per kilo to maximum of 400 units
|
|
2: Placebo Comparator
saline injection
|
Drug: saline injection
10 units per kilo to maximum of 400 units
|
The specific aims are to determine if BTX-A will:
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| Ages Eligible for Study: | 5 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Reggie Hamdy, MD | 514-282-7150 | rhamdy@shriners.mcgill.ca |
| Contact: Kathleen Montpetit, MScOT | 514-282-6962 | kmontpetit@shrinenet.org |
| United States, Delaware | |
| Alfred I.duPont Hospital for Children | Recruiting |
| Wilmington, Delaware, United States, 19899 | |
| Contact: Aaron Littleton 302-651-5906 aalittle@nemours.org | |
| Contact: William MacKenzie, MD (302) 651-4000 wmackenz@nemours.org | |
| Principal Investigator: William MacKenzie, MD | |
| United States, Hawaii | |
| Shriners Hospital for Children | Recruiting |
| Honolulu, Hawaii, United States, 96826-1099 | |
| Contact: Ramona Fillman 808-951-3693 rfillman@shrinenet.org | |
| Contact: Ellen Raney, MD (808) 951-3640 eraney@shrinenet.org | |
| Principal Investigator: Ellen Raney, MD | |
| United States, Oregon | |
| Shriners Hospital for Children | Recruiting |
| Portland, Oregon, United States, 97239-3095 | |
| Contact: Susan Sienko 503-221-3481 sst@shcc.org | |
| Contact: Michael Aiona, MD (503) 221-3424 maiona@shrinenet.org | |
| Principal Investigator: Michael Aiona, MD | |
| United States, Pennsylvania | |
| Shriners Hospital for Children | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Ross Chafetz, MPH 215-430-4114 rchafetz@shrinenet.org | |
| Contact: James McCarthy, MD (215) 430-4022 jmccarthy@shrinenet.org | |
| Principal Investigator: James McCarthy, MD | |
| Canada, Ontario | |
| The Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5g 1X8 | |
| Contact: Shannon Weir 416-813-6608 shannon.weir@sickkids.ca | |
| Contact: Unni Narayanan, MD (416) 813-6432 unni.narayanan@sickkids.ca | |
| Principal Investigator: Unni Narayanan, MD | |
| Canada, Quebec | |
| Shriners Hospital for Children | Recruiting |
| Montreal, Quebec, Canada, H3G 1A6 | |
| Contact: Kathleen Montpetit, MScOT 514-282-6962 kmontpetit@shrinenet.org | |
| Contact: Reggie Hamdy, MD 514-282-7150 rhamdy@shriners.mcgill.ca | |
| Principal Investigator: Reggie Hamdy, MD | |
| Principal Investigator: | Reggie Hamdy, MD | Shriners Hospital for Children-Canadian Unit, Montreal, Quebec |
More Information
| Responsible Party: | Shriners Hospital for Children Portland ( Michael Aiona, MD ) |
| Study ID Numbers: | 9055 |
| Study First Received: | December 13, 2006 |
| Last Updated: | June 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00412035 |
| Health Authority: | United States: Food and Drug Administration |
|
Botulinum Toxins Quality of Life Pain |
Botulinum Toxin Type A Congenital Abnormalities Pain, Postoperative |
|
Anti-Dyskinesia Agents Therapeutic Uses Central Nervous System Agents Pharmacologic Actions |
