Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 1:29 PM
Study NCT ID:
NCT06249906
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Bioceramic Materials for Bone Defects Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-08', 'studyFirstSubmitDate': '2023-12-15', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain self-efficacy (PSEQ)', 'timeFrame': 'through study completion, about 12 months', 'description': 'The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire, developed in the 1980s by Michael Nicholas to assess the confidence people with ongoing pain have in performing activities while in pain. The PSEQ is applicable to all persisting pain presentations.'}, {'measure': 'Incidence of nonunion', 'timeFrame': 'through study completion, about 12 months', 'description': 'A nonunion is an arrest in the fracture repair process.'}, {'measure': 'Incidence of infections', 'timeFrame': 'through study completion, about 12 months', 'description': 'If any infections happen, the experiment would be stopped.'}], 'primaryOutcomes': [{'measure': 'Quality of life (SF-36)', 'timeFrame': '12 months', 'description': 'SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used.'}, {'measure': 'Level of bone healing', 'timeFrame': '12 months', 'description': 'X-ray, CT and MRI images would be used to evaluate the efficacy of bone healing.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Lesion', 'Cartilage Degeneration', 'Osteo Arthritis Knee', 'Bone Fracture', 'Bone Injury', 'Bone Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the effect of bioceramic implants on the repair of human bone defects, and to explore the application of bioceramic materials in bone defects, bone implantation, and bone fusion. The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.', 'detailedDescription': 'The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients who voluntarily take the test and sign the informed consent form;\n2. Patients aged 18-65 years old with no history of allergies;\n3. Patients able to communicate well with the investigator and follow the requirements of the entire trial.\n\nExclusion Criteria:\n\n1. Patients who refuse to sign the informed consent form to participate in the trial;\n2. Patients who are not in the age range of 18 to 65 years;\n3. Patients with diseases unsuitbale for the trial: history of allergies, severe cardiopulmonary disease, coagulation dysfunction, Alzheimer's disease, cerebral atrophy, acute phase or sequelae of cerebrovascular disease, cognitive impairment;\n4. Patients in the acute phase of local or systemic bacterial infections;\n5. Patients who cannot cooperate with the operation and evaluate the effect;\n6. Other conditions that are considered inappropriate by the investigator to participate in the study."}, 'identificationModule': {'nctId': 'NCT06249906', 'briefTitle': 'Efficacy of Bioceramic Materials for Bone Defects Repair', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Clinical Study of Bioceramic Materials in Bone Defect Repair', 'orgStudyIdInfo': {'id': 'KY20231109-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial bone implant product Group', 'description': 'Bone repair products in the market such as artificial bones and allogeneic bones.', 'interventionNames': ['Device: Commercial bone implant product Group']}, {'type': 'EXPERIMENTAL', 'label': 'Mirco-structured Bioceramic Group', 'description': 'β-Tricalcium phosphate (β-TCP) is a material with excellent biocompatibility and osteoinduction and bone guidance properties, which can provide mechanical strength equal to or better than that of human cancellous bone.', 'interventionNames': ['Device: Mirco-structured Bioceramic Group']}], 'interventions': [{'name': 'Commercial bone implant product Group', 'type': 'DEVICE', 'description': 'Commercial bone implant product Group with a smooth surface （without particular microstructures）.', 'armGroupLabels': ['Commercial bone implant product Group']}, {'name': 'Mirco-structured Bioceramic Group', 'type': 'DEVICE', 'description': 'β-tri-Calcium phosphate with microstructures such as grooves, patterns and so on.', 'armGroupLabels': ['Mirco-structured Bioceramic Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yufeng Wang, Master', 'role': 'CONTACT', 'email': 'wanyufeng2@126.com', 'phone': '+86 15895982668'}], 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Qingqiang Yao, phD', 'role': 'CONTACT', 'email': 'yaoqingqiang@126.com', 'phone': '15366155699'}], 'overallOfficials': [{'name': 'Qingqiang Yao, phD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}