Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-02 @ 3:55 AM
Study NCT ID:
NCT06959459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-06
First Post:
2025-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 156}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2025-05-05', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone graft fusion rate', 'timeFrame': '24weeks after surgery'}], 'secondaryOutcomes': [{'measure': 'Bone defect healing rate', 'timeFrame': '4 and 12 weeks after surgery'}, {'measure': 'New bone formation rate', 'timeFrame': '4, 12 and 24 weeks after surgery'}, {'measure': 'SF-36 scale', 'timeFrame': '24 weeks after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Defects of the Limbs']}, 'descriptionModule': {'briefSummary': 'Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities: A Prospective, Randomized Controlled, Single-Blind, Non-Inferiority Clinical Trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 60 years old, regardless of sex;\n2. Cavitary bone defects in the limbs requiring bone grafting treatment;\n3. Bone defect volume ≥ 1 cm³ and ≤ 8 cm³, with only one bone defect requiring intervention;\n4. Subjects or their legal guardians can understand the study objectives, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Open fractures with wound contamination;\n2. Repair of infectious bone defects;\n3. Structural bone grafting required at the defect site;\n4. Osteofascial compartment syndrome in the affected limb scheduled for surgery;\n5. Presence of systemic infection, uncontrolled local infection at the surgical site, malignant tumor (including metastatic tumors) at the defect site, osteonecrosis at the defect site, severe nerve/soft tissue/vascular injury at the defect site, confirmed severe malnutrition, or dysfunction/failure of other vital organs;\n6. Calcium and phosphorus metabolic abnormalities (calcium/phosphorus levels \\> 1.5 times the upper limit of normal values);\n7. History of diabetes with fasting blood glucose ≥ 6.1 mmol/L;\n8. Coagulation dysfunction (prothrombin time \\[PT\\] or activated partial thromboplastin time \\[APTT\\] \\> 2 times the upper limit of normal values);\n9. Use of chemotherapeutic agents or receipt of radiotherapy within 3 months prior to enrollment;\n10. Cumulative use of corticosteroids or growth factors for ≥ 14 days within 1 month prior to enrollment;\n11. Long-term use of sedative-hypnotic drugs (continuous use for \\> 3 months) or non-steroidal anti-inflammatory drugs (NSAIDs, continuous use for \\> 3 months);\n12. Known allergy to bovine-derived materials or collagen products;\n13. Pregnant or lactating females;\n14. Participation in other interventional clinical trials for drugs or medical devices within 1 month prior to enrollment;\n15. Any other conditions where investigators, in their professional judgment, deem the subject ineligible to participate in the trial for the subject's safety or benefit."}, 'identificationModule': {'nctId': 'NCT06959459', 'briefTitle': 'Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities: A Prospective, Randomized Controlled, Single-Blind, Non-Inferiority Clinical Trial', 'orgStudyIdInfo': {'id': '2024QX008-KS002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.', 'interventionNames': ['Device: Intervention Group:Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.', 'interventionNames': ['Device: Control group: Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.']}], 'interventions': [{'name': 'Intervention Group:Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.', 'type': 'DEVICE', 'description': 'Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Control group: Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.', 'type': 'DEVICE', 'description': 'Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Meng Li', 'role': 'CONTACT', 'email': 'limeng1@301.hospital.com.cn'}], 'facility': 'Chinese PLA General Hosptial', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wei Zhang', 'role': 'CONTACT', 'email': 'bszw@hotmail.com', 'phone': '+86 15334508850'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy head of orthopedics', 'investigatorFullName': 'Zhang Wei', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}