Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-28 @ 12:45 AM
Study NCT ID:
NCT05616195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2022-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of 3D Printed Prosthesis in Limb Salvage Surgery for Bone Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2032-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complications', 'timeFrame': 'From surgery to 24 months after surgery', 'description': 'Complications were collected from patients who underwent 3D-printed bone prosthesis replacement surgery.'}, {'measure': 'Limb function', 'timeFrame': 'Patients were enrolled until 24 months after surgery', 'description': 'Limb function was assessed using the Musculoskeletal Oncology Society (MSTS) scoring scale for seven items, namely movement, pain, stability, deformity, strength, functional activity, and emotional receptiveness. The highest possible score is 35, with 5 points allocated to each project.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Tumor']}, 'descriptionModule': {'briefSummary': 'To report the patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital in the next 10 years, and collect the postoperative complications and limb function of these patients.', 'detailedDescription': 'To report the patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital in the next 10 years. The basic data, treatment methods, postoperative complications and limb function of these patients were collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing 3D-printed bone prosthesis replacement surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMen and women of all ages are welcome.\n\nPathologically confirmed in our hospital as a subtype of malignant tumor.\n\nHe received 3D printed bone prosthesis replacement in our hospital.\n\nExclusion Criteria:\n\nNot applicable.'}, 'identificationModule': {'nctId': 'NCT05616195', 'briefTitle': 'Application of 3D Printed Prosthesis in Limb Salvage Surgery for Bone Tumors', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'Application of 3D Printed Bone Prosthesis in Limb Salvage Surgery for Bone Tumors: a Single-center, Real-world Prospective Observational Study', 'orgStudyIdInfo': {'id': 'ZZUSC-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3D printed bone prosthesis replacement surgery', 'description': 'Patients undergoing 3D-printed bone prosthesis replacement surgery', 'interventionNames': ['Other: 3D printed bone prosthesis replacement surgery']}], 'interventions': [{'name': '3D printed bone prosthesis replacement surgery', 'type': 'OTHER', 'description': 'To report the postoperative complications and limb function of patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital.', 'armGroupLabels': ['3D printed bone prosthesis replacement surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Tian Zhichao, Dr.', 'role': 'CONTACT', 'email': 'tianzhichhaoyy@163.com', 'phone': '+8618737187831'}], 'facility': 'Department of Bone and Soft Tissue ,Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate chief physician', 'investigatorFullName': 'Wang Jiaqiang', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}