Ignite Creation Date:
2025-12-24 @ 12:33 PM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT05251961
Status:
UNKNOWN
Last Update Posted:
2022-03-10
First Post:
2022-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use Of Growing Rods In Pediatric Long Bones Deformity Correction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-22', 'studyFirstSubmitDate': '2022-02-11', 'studyFirstSubmitQcDate': '2022-02-11', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Use Of Growing Rods In Pediatric Long Bones Deformity Correction', 'timeFrame': '2 years', 'description': '\\- Evaluation of deformity angles correction after use of growing rods in comparison with preoperative angle'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deformity of Limb']}, 'referencesModule': {'references': [{'pmid': '30216208', 'type': 'BACKGROUND', 'citation': 'Sarikaya I, Seker A, Erdal OA, Gunay H, Inan M, Guler B. Using a corkscrew-tipped telescopic nail in the treatment of osteogenesis imperfecta: a biomechanical study and preliminary results of 17 consecutive cases. J Pediatr Orthop B. 2019 Mar;28(2):173-178. doi: 10.1097/BPB.0000000000000537.'}, {'pmid': '30212425', 'type': 'BACKGROUND', 'citation': "Persiani P, Ranaldi FM, Martini L, Zambrano A, Celli M, D'Eufemia P, Villani C. Treatment of tibial deformities with the Fassier-Duval telescopic nail and minimally invasive percutaneous osteotomies in patients with osteogenesis imperfecta type III. J Pediatr Orthop B. 2019 Mar;28(2):179-185. doi: 10.1097/BPB.0000000000000536."}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the value of growing rods for the correction of long bone deformities in pediatric cases attending Sohag University Hospital and follow up aiming at determining benefits and obstacles to this technique', 'detailedDescription': '* The participants will be subjected to surgical correction using growing rods as a novel technique for their long bone deformities.\n* Procedure will be done under anaesethia\n* Osteotomy , fracture reduction , deformity correction will be done , then introduction of the growing rod'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cases of osteogenesis imperfecta\n* metabolic bone deformities\n* cases of hemimelia\n* traumatic bone deformities\n* complex or simple deformities\n\nExclusion Criteria:\n\n* adult deformities\n* short bone deformities\n* very narrow medulla\n* osteopetrosis'}, 'identificationModule': {'nctId': 'NCT05251961', 'briefTitle': 'The Use Of Growing Rods In Pediatric Long Bones Deformity Correction', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'The Use Of Growing Rods In Pediatric Long Bones Deformity Correction', 'orgStudyIdInfo': {'id': 'pediatric deformity correction'}}, 'armsInterventionsModule': {'interventions': [{'name': 'operative deformity correction', 'type': 'PROCEDURE', 'description': '* The participants will be subjected to surgical correction using growing rods as a novel technique for their long bone deformities.\n* Procedure will be done under anaesethia\n* Osteotomy , fracture reduction , deformity correction will be done , then introduction of the growing rod'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abdelmageed Aboelabbas', 'role': 'CONTACT', 'email': 'abdelmageed.ortho87@yahoo.com', 'phone': '00201002711810'}, {'name': 'Ahmad Addosooki', 'role': 'CONTACT', 'email': 'addosooki@gmail.com', 'phone': '00201011110232'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Abdelmajeed Aboelabaas Abdelmajeed', 'investigatorAffiliation': 'Sohag University'}}}}