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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox | Active Comparator | Botulinum toxin A injection |
|
| Placebo | Placebo Comparator | saline injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin A injection | Drug | 10 units per kilo to maximum of 400 units |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reggie Hamdy, MD | Shriners Hospital for Children-Canadian Unit, Montreal, Quebec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred I.duPont Hospital for Children | Wilmington | Delaware | 19899 | United States | ||
| Shriners Hospital for Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17903262 | Background | 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. | |
| 19934710 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 26, 2017 | |
| Reset | May 30, 2017 |
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| saline injection | Drug | 10 units per kilo to maximum of 400 units |
|
|
| 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 |
| Honolulu |
| Hawaii |
| 96826-1099 |
| United States |
| Shriners Hospital for Children | Portland | Oregon | 97239-3095 | United States |
| Shriners Hospital for Children | Philadelphia | Pennsylvania | 19140 | United States |
| The Hospital for Sick Children | Toronto | Ontario | M5g 1X8 | Canada |
| Shriners Hospital for Children | Montreal | Quebec | H3G 1A6 | Canada |
| 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. |
| 19568011 | Result | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 26, 2017 | May 30, 2017 |
| ID | Term |
|---|---|
| D038061 | Lower Extremity Deformities, Congenital |
| ID | Term |
|---|---|
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D012965 | Sodium Chloride |
| D005457 | Fluoridation |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
| D011636 | Public Health Dentistry |
| D004778 | Environment and Public Health |
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