Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT01328418
Status:
COMPLETED
Last Update Posted:
2011-04-04
First Post:
2011-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004392', 'term': 'Dwarfism'}], 'ancestors': [{'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-01', 'studyFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2011-04-01', 'lastUpdatePostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Paley's functional scoring system", 'timeFrame': 'Minimum 2 year follow-up', 'description': "Paley's functional scoring system evaluates the results after lengthening or deformity correction procedures: residual limb length discrepancy, any brace or other aid usage, joint contracture, pain, soft tissue dystrophism"}]}, 'conditionsModule': {'keywords': ['Lengthening'], 'conditions': ['SHOX Gene With Short Stature']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether lengthening of both the tibiae and femora in achondroplastic patients is safe and provides reproducible outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Achondroplasia, first lengthening period\n\nExclusion Criteria:\n\n* Previous lengthening'}, 'identificationModule': {'nctId': 'NCT01328418', 'briefTitle': 'Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients', 'organization': {'class': 'INDIV', 'fullName': 'Bilen, Fikri Erkal, M.D.'}, 'officialTitle': 'Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients', 'orgStudyIdInfo': {'id': 'Akondroplazi - Bilen'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Achondroplasia lengthening', 'interventionNames': ['Procedure: Lengthening over nail']}], 'interventions': [{'name': 'Lengthening over nail', 'type': 'PROCEDURE', 'description': 'External fixator is used to lengthen either the femur or the tibia over an intramedullary nail', 'armGroupLabels': ['Achondroplasia lengthening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34390', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medical School', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bilen, Fikri Erkal, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'oldNameTitle': 'Mehmet Kocaoglu, MD, Professor', 'oldOrganization': 'Istanbul Medical School'}}}}