Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT04883502
Status:
RECRUITING
Last Update Posted:
2022-12-21
First Post:
2021-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* 1 blood sample\n* 3 fragments of induced membrane\n* 1 fragment of periosteum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histological profile of induced membrane fragments', 'timeFrame': 'Through study completion, an average of 6,5 years', 'description': 'Presence of abnormalities in the organization of connective fibers. The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.'}, {'measure': 'Cellular profile of induced membrane fragments', 'timeFrame': 'Through study completion, an average of 6,5 years', 'description': 'Presence of mesenchymal stromal cells, ability of these cells to differentiate into osteoblasts, presence of other cell types (such as adipocytes and osteoclasts).\n\nThe profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.'}, {'measure': 'Secretory profile of induced membrane fragments', 'timeFrame': 'Through study completion, an average of 6,5 years', 'description': 'Determination of proteins secreted by the induced membrane fragments by mass spectrometry or by enzyme-linked immunosorbent assay.\n\nThe profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.'}, {'measure': 'Gene expression profile of induced membrane fragments', 'timeFrame': 'Through study completion, an average of 6,5 years', 'description': 'Expression of several genes of interest related to angiogenesis, mesenchymal stromal cells mobilization, bone formation or resorption and extracellular matrix remodeling.\n\nThe profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Masquelet technique', 'Induced membrane technique'], 'conditions': ['Bone Loss']}, 'descriptionModule': {'briefSummary': 'Masquelet\'s induced membrane technique is a two-stage reconstructive surgery for severe bone fractures commonly used by military orthopedists. The particularity of this technique relies on the synthesis of a biological membrane induced by the transient implantation of a surgical cement (= 1st stage surgery). The presence of the induced membrane in the reconstruction space defines a microenvironment or "biological chamber" favourable to osteogenesis, positively influencing the repair of the lesion after implantation of an autologous bone graft (= 2nd stage of surgery).\n\nIn view of the excellent clinical results obtained with this procedure, the Masquelet technique has gradually become a reference treatment in the field of orthopedic and trauma surgery.\n\nHowever, orthopedic surgeons sometimes observe failures in bone consolidation. To our knowledge, the role played by induced membrane in these therapeutic failures has never been studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is composed of patients with traumatic bone loss who are eligible for the induced membrane technique.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient with traumatic bone loss\n* Patient eligible for the induced membrane technique\n\nExclusion Criteria:\n\n* Patients with post-tumor bone loss\n* Patients who are immunocompromised or under immunosuppressive treatment\n* Patients with chronic inflammatory disease (diabetes, inflammatory bowel disease)\n* Patients with collagenosis\n* Patient with a contraindication to sampling\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT04883502', 'acronym': 'MEMBRAN', 'briefTitle': 'Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs', 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': 'Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs', 'orgStudyIdInfo': {'id': '2019PPRC03'}, 'secondaryIdInfos': [{'id': '2021-A00561-40', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood sample collection', 'type': 'BIOLOGICAL', 'description': 'A blood sample will be collected at enrollment.'}, {'name': 'Other biological sample collection', 'type': 'BIOLOGICAL', 'description': 'The following biological samples will be collected during the first surgery:\n\n* 1 blood sample\n* 3 fragments of induced membrane\n* 1 fragment of periosteum'}, {'name': 'Surgical waste collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'The pieces of polymethylmethacrylate surgical cement will be collected during the second surgery.'}, {'name': 'Radiological examination and functional exploration', 'type': 'DIAGNOSTIC_TEST', 'description': 'A radiological examination and a functional exploration will be performed 6 weeks, 3 months and 6 months after the first surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92140', 'city': 'Clamart', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent MATHIEU, MD, PhD', 'role': 'CONTACT', 'email': 'laurent-m2.mathieu@intradef.gouv.fr', 'phone': '141466157', 'phoneExt': '+33'}], 'facility': "Hôpital d'Instruction des Armées Percy", 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '94160', 'city': 'Saint-Mandé', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas DEMOURES, MD', 'role': 'CONTACT', 'email': 'thomas.demoures@intradef.gouv.fr', 'phone': '140514103', 'phoneExt': '+33'}], 'facility': "Hôpital d'Instruction des Armées Bégin", 'geoPoint': {'lat': 48.83864, 'lon': 2.41579}}], 'centralContacts': [{'name': 'Marjorie DURAND, PhD', 'role': 'CONTACT', 'email': 'marjorie1.durand@intradef.gouv.fr', 'phone': '178651146', 'phoneExt': '+33'}, {'name': 'Laurent MATHIEU, MD, PhD', 'role': 'CONTACT', 'email': 'laurent-m2.mathieu@intradef.gouv.fr', 'phone': '141466157', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}