Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 10:47 AM
Study NCT ID:
NCT05631951
Status:
UNKNOWN
Last Update Posted:
2023-01-09
First Post:
2022-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Transport Through Induced Membrane vs Conventional Bone Transport in Management of Bone Defects of Lower Limbs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '30 patients were included and divided randomly into two equal groups:\n\n* Group (A) will undergo BTM\n* Group (B) will undergo BT\n\nMethods:\n\nI. Preoperative evaluation\n\nII. Operative interventions:\n\nA. Pre-operative:\n\nB. Operative interventions\n\n* first step\n\n • resection of infected bone\n* Second step:\n\n(A) Group A cement spacer and external fixator were applied then removal of cement spacer and metaphyseal osteotomy done (B)Group B\n\n* external fixator was applied then metaphyseal osteotomy done C. Post-operative\n* bone transport was started after latency of 7 days (from osteotomy) at rate of 1mm per day in 4 increments per day (rhythm of 0.25 mm every 6 hours) until reaching docking site.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-06', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-20', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'External fixation time', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'time from the initial application of the fixator until removal of fixator (in months)'}, {'measure': 'External fixation index', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'calculated by dividing the EFT (months) by the bone defect size (centimeters)'}, {'measure': 'Docking time', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'time taken (months) from end of bone transport till union of docking site (both with and without bone graft)'}, {'measure': 'Association for the Study and Application of the Method of Ilizarov (ASAMI) Scoring System', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'scoring system for bone and functional results'}, {'measure': 'complications rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'number of complications in each group'}, {'measure': 'additional operations', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'number of additional operations in each group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Loss']}, 'referencesModule': {'references': [{'pmid': '25840909', 'type': 'BACKGROUND', 'citation': 'Marais LC, Ferreira N. Bone transport through an induced membrane in the management of tibial bone defects resulting from chronic osteomyelitis. Strategies Trauma Limb Reconstr. 2015 Apr;10(1):27-33. doi: 10.1007/s11751-015-0221-7. Epub 2015 Apr 4.'}, {'pmid': '20417920', 'type': 'BACKGROUND', 'citation': 'Uzel AP, Lemonne F, Casoli V. Tibial segmental bone defect reconstruction by Ilizarov type bone transport in an induced membrane. Orthop Traumatol Surg Res. 2010 Apr;96(2):194-8. doi: 10.1016/j.rcot.2010.02.001.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective randomised controlled comparative study comparing bone transport through induced membrane (BTM) and conventional bone transport (BT) in management of bone defects in infected non united fractures of long bones of lower limbs (femur, tibia) as regard clinical, functional outcomes and possible complications.', 'detailedDescription': 'A prospective randomised controlled study was conducted at Ain shams university hospitals. A total of 30 patients with infected non united fractures of long bones of lower limbs (femur and tibia) were divided randomly into 15 patients treated by bone transport through induced membrane technique (BTM) (Group A) and 15 patients treated by conventional bone transport technique (BT) (Group B)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sex: both sexes.\n* Age:18-60 yrs old.\n* Lesion: tibial or femoral bone defects (\\>4 cm)\n* Defects resulting from infected non-united fractures\n\nExclusion Criteria:\n\n* Pathological and congenital defects\n* Aseptic traumatic bone defects\n* Defects less than 4 cm\n* Multiple defects Pediatric age group'}, 'identificationModule': {'nctId': 'NCT05631951', 'briefTitle': 'Bone Transport Through Induced Membrane vs Conventional Bone Transport in Management of Bone Defects of Lower Limbs', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Bone Transport Through Induced Membrane Technique Versus Conventional Bone Transport Technique in Management of Bone Defects of Lower Limbs', 'orgStudyIdInfo': {'id': 'FMASU MD57/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bone transport through induced membrane', 'description': 'First stage\n\n1. antibiotic impregnated cement spacer was applied to the bone defect\n2. external fixator was applied for 6-8 weeks ϖ Second stage\n\n1.removal of cement spacer done 2.metaphyseal osteotomy done', 'interventionNames': ['Procedure: bone transport through induced membrane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bone transport', 'description': '1. removal of all hardware\n2. resection of infected bone segments\n3. external fixator was applied\n4. metaphyseal osteotomy done', 'interventionNames': ['Procedure: bone transport']}], 'interventions': [{'name': 'bone transport through induced membrane', 'type': 'PROCEDURE', 'description': 'Debridement done followed by external fixator and cement application to be followed by removal of cement (after 6 weeks) and start bone transport', 'armGroupLabels': ['bone transport through induced membrane']}, {'name': 'bone transport', 'type': 'PROCEDURE', 'description': 'Debridement done then external fixator was applied then bone transport started.', 'armGroupLabels': ['bone transport']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mootaz F Thakeb, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}