Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-03-10 @ 7:48 PM
Study NCT ID:
NCT03941028
Status:
UNKNOWN
Last Update Posted:
2019-05-07
First Post:
2019-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effects of Large Segmental Bone Defects With 3D Printed Titanium Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-05', 'studyFirstSubmitDate': '2019-04-15', 'studyFirstSubmitQcDate': '2019-05-05', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Questionnaire of patients' satisfaction degree", 'timeFrame': '1 year', 'description': 'VAS score is used to evaluate the satisfaction degree. The score ranges from 0 to 10, 0 means very dissatisfied and 10 means very satisfied.'}], 'primaryOutcomes': [{'measure': 'Bone reconstruction', 'timeFrame': '1 year', 'description': 'X-rays and CT scans are used to evaluate the bone reconstruction'}], 'secondaryOutcomes': [{'measure': 'Questionnaire of limb function', 'timeFrame': '1 year', 'description': 'Restoration of limb function.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Large Segmental Bone Defect']}, 'descriptionModule': {'briefSummary': 'The investigators apply 3D printed titanium implant to treat bone defects. Without using bone grafts and growth factors, the investigators anticipate the titanium implant alone can help bone reconstruction.', 'detailedDescription': "The investigators treat large segmental bone defects caused by three reasons, including trauma, infection and tumor. In this study, polyporous 3D printed titanium implant is applied to reconstruct the bone defects and the investigators will follow up patients' function and bone regeneration."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bone defects caused by trauma or infection or tumor\n* the length of bone defect is more than 6cm\n* more than 18 years old\n\nExclusion Criteria:\n\n* malignant tumor\n* patients with bad conditions failing to tolerate surgery'}, 'identificationModule': {'nctId': 'NCT03941028', 'briefTitle': 'Clinical Effects of Large Segmental Bone Defects With 3D Printed Titanium Implant', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Clinical Effects of Large Segmental Bone Defects Caused by Trauma, Infection and Tumor With 3D Printed Titanium Implant', 'orgStudyIdInfo': {'id': 'Z181100001718195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bone defects caused by trauma', 'description': 'Large bone defects (\\>6cm) caused by trauma', 'interventionNames': ['Device: 3D printed titanium implant']}, {'type': 'EXPERIMENTAL', 'label': 'bone defects caused by infection', 'description': 'Large bone defects caused by chronic osteomyelitis', 'interventionNames': ['Device: 3D printed titanium implant']}, {'type': 'EXPERIMENTAL', 'label': 'bone defects caused by tumor', 'description': 'Large bone defects caused by benign tumor', 'interventionNames': ['Device: 3D printed titanium implant']}], 'interventions': [{'name': '3D printed titanium implant', 'type': 'DEVICE', 'description': 'The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.', 'armGroupLabels': ['bone defects caused by infection', 'bone defects caused by trauma', 'bone defects caused by tumor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yun Tian, MD', 'role': 'CONTACT', 'email': 'tiany@bjmu.edu.cn', 'phone': '+8610-82267010'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Bingchuan Liu, MD', 'role': 'CONTACT', 'email': 'liubc@bjmu.edu.cn', 'phone': '+86-18310188678'}], 'overallOfficials': [{'name': 'Yun Tian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}