Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-02 @ 1:39 PM
Study NCT ID:
NCT00412035
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2006-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-05-30', 'releaseDate': '2017-04-26'}], 'estimatedResultsFirstSubmitDate': '2017-04-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D038061', 'term': 'Lower Extremity Deformities, Congenital'}], 'ancestors': [{'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D005457', 'term': 'Fluoridation'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D011636', 'term': 'Public Health Dentistry'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-22', 'studyFirstSubmitDate': '2006-12-13', 'studyFirstSubmitQcDate': '2006-12-13', 'lastUpdatePostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'average pain scores in 1st 4 days post op', 'timeFrame': '1st 4 days post op'}, {'measure': 'total amount of narcotic used in 1st 4 days post op', 'timeFrame': '1st 4 days post op'}], 'secondaryOutcomes': [{'measure': 'Quality of life (PedsQL)', 'timeFrame': 'pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal'}, {'measure': 'Active and passive range of motion', 'timeFrame': 'pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal'}, {'measure': 'Muscle strength', 'timeFrame': 'pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal'}, {'measure': 'Ambulation scores (FAQ)', 'timeFrame': 'pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Unequal Length of Limbs; Congenital', 'Lower Extremity Deformities, Congenital']}, 'referencesModule': {'references': [{'pmid': '17903262', 'type': 'BACKGROUND', '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. doi: 10.1186/1745-6215-8-27.'}, {'pmid': '19934710', 'type': 'BACKGROUND', '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.'}, {'pmid': '19568011', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The specific aims are to determine if BTX-A will:\n\n* 1a. Reduce pain post operatively and during the distraction and consolidation process,\n* 1b. Reduce the amount, frequency and duration of narcotics taken in the postoperative period.\n* 2\\. Improve the quality of life during the distraction and consolidation process.\n* 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.\n* 4\\. To develop clinical practice guidelines for the interdisciplinary care of children undergoing limb lengthening or deformity correction.\n\nMethodology: 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 5 to 21 years.\n* Aetiology of the deformity: congenital or acquired.\n* Amount of lengthening or deformity correction: any amount.\n* Site of lengthening or deformity correction: lower extremity.\n* Type of fixator: circular or uniplanar.\n\nExclusion Criteria:\n\n* Children younger than 5 years of age.\n* Associated neuromuscular conditions that may hinder weight bearing.\n* Individuals on aminoglycosides, as aminoglycosides can potentiate the effect of Botulinum toxin A.'}, 'identificationModule': {'nctId': 'NCT00412035', 'acronym': 'BOLLD', 'briefTitle': 'Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Shriners Hospitals for Children'}, 'officialTitle': 'Safety and Efficacy of Botox Injection in Alleviating Post-Operative Pain and Improving Quality of Life in Lower Extremity Limb Lengthening and Deformity Correction', 'orgStudyIdInfo': {'id': '9142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Botox', 'description': 'Botulinum toxin A injection', 'interventionNames': ['Drug: Botulinum toxin A injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'saline injection', 'interventionNames': ['Drug: saline injection']}], 'interventions': [{'name': 'Botulinum toxin A injection', 'type': 'DRUG', 'otherNames': ['botox'], 'description': '10 units per kilo to maximum of 400 units', 'armGroupLabels': ['Botox']}, {'name': 'saline injection', 'type': 'DRUG', 'otherNames': ['salt water'], 'description': '10 units per kilo to maximum of 400 units', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I.duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '96826-1099', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Shriners Hospital for Children', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '97239-3095', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Shriners Hospital for Children', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Shriners Hospital for Children', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': 'M5g 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3G 1A6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Shriners Hospital for Children', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Reggie Hamdy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shriners Hospital for Children-Canadian Unit, Montreal, Quebec'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shriners Hospitals for Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Reggie Hamdy, MD', 'investigatorAffiliation': 'Shriners Hospitals for Children'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-04-26', 'type': 'RELEASE'}, {'date': '2017-05-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Reggie Hamdy, MD, Principal Investigator, Shriners Hospitals for Children'}}}}