Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT05423561
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2022-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-14', 'studyFirstSubmitDate': '2022-06-09', 'studyFirstSubmitQcDate': '2022-06-14', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Provide Bone Union', 'timeFrame': '6 months', 'description': 'Achievement of bone union with detecting callus formation on radiography after passing the region of corticalisation with a longer and thicker nail'}, {'measure': 'Relieving pain in the nonunion area', 'timeFrame': '6 weeks', 'description': 'Detection of reduction of pain scores in the nonunion area and enabling patients to load on the extremity in the early period postoperatively'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertrophic pseudarthrosis', 'dynamization', 'corticalisation'], 'conditions': ['Pseudoarthrosis of Bone', 'Implant Breakage']}, 'descriptionModule': {'briefSummary': 'In 12 patients with corticalization and hypertrophic pseudarthrosis were present after dynamization, the old nail was removed and nail exchange was performed with a longer and larger diameter nail to pass the region formed in the cortex approximately 2-3cm inferior from the old nail.', 'detailedDescription': 'Corticalization is cortex-like sclerosis in the distal of the nail and it may indicate the early sign of dynamization treatment failure in hypertrophic nonunion after femoral transverse diaphyseal fractures. When corticalization is seen during follow-up after dynamization is performed because of non-union of a femoral transverse fracture, nail exchange should be performed without further delay. More rigid fixation should be applied with a longer and thicker nail crossing the area of corticalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '28 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subtrochanteric fractures\n* Nonunion with Pain\n\nExclusion Criteria:\n\n* Infection\n* Pathological Fracture (Tumor)'}, 'identificationModule': {'nctId': 'NCT05423561', 'briefTitle': 'Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions', 'organization': {'class': 'OTHER', 'fullName': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, 'officialTitle': 'Sclerotic Bone Formation (Corticalisation) on the Intramedullar Nail Tip in Hypertrophic Non-union Developing After Femoral Transverse Diaphyseal Fractures', 'orgStudyIdInfo': {'id': 'E-48670771-514.99'}, 'secondaryIdInfos': [{'id': '67', 'type': 'REGISTRY', 'domain': 'Desicion number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'hypertrophic non-union developing after femoral transverse diaphyseal fractures', 'interventionNames': ['Procedure: exchange nailing with larger, thicker nail crossing corticalization']}], 'interventions': [{'name': 'exchange nailing with larger, thicker nail crossing corticalization', 'type': 'PROCEDURE', 'description': 'exchange nailing with larger, thicker nail crossing corticalization', 'armGroupLabels': ['hypertrophic non-union developing after femoral transverse diaphyseal fractures']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'Ali Çağrı Tekin', 'investigatorAffiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}}}}