Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT04806360
Status:
UNKNOWN
Last Update Posted:
2022-05-09
First Post:
2021-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-04', 'studyFirstSubmitDate': '2021-02-16', 'studyFirstSubmitQcDate': '2021-03-18', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Japanese Orthopaedic Association Score (JOA)', 'timeFrame': 'baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment', 'description': 'Total score 0-17. The lower the score the more severe the deficits.'}, {'measure': 'Change of Neck Disability Index (NDI)', 'timeFrame': 'baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment', 'description': 'Ranging from 0%-100%. A higher score indicates more patient-rated disability.'}, {'measure': 'Change of Sagittal Lordosis Angle', 'timeFrame': 'baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment', 'description': 'Measured by lateral X-Ray image. The change of lordosis was calculated and compared.'}, {'measure': 'Change of Cross-sectional area of the spinal canal', 'timeFrame': 'baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment', 'description': 'Measured by MRI image. The change of cross-sectional area of the spinal canal was calculated and compared.'}], 'secondaryOutcomes': [{'measure': 'Reoperation rate', 'timeFrame': '1 month, 3 months, 6 months, 12 months and 24 months post-treatment', 'description': 'Any reoperation involving the same segments or adjacent segments will be calculated.'}, {'measure': 'Change of Pain Scores on the Visual Analog Scale (VAS)', 'timeFrame': 'baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment', 'description': 'Ranging from 0-10. A higher score indicates more severe pain.'}, {'measure': 'Change of Range of Motion', 'timeFrame': 'baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment', 'description': 'Measured by dynamic X-Ray image.'}, {'measure': 'Complication rate', 'timeFrame': 'baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment', 'description': 'Any complications related to surgery will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Degenerative Cervical Kyphosis With Stenosis']}, 'descriptionModule': {'briefSummary': 'Degenerative cervical kyphosis with stenosis (DCKS) is a common cervical spine degenerative disease, causing pain, numbness, and weakness of limbs, which seriously affect the quality of life of the patient. Surgery is an effective way to treat this condition, however, the best surgical procedure is still controversial. Anterior spinal canal reconstruction and fusion surgery (ACRF) is a new surgical procedure that previously proposed by our team, it combines the advantages of both the conventional anterior and posterior approach. The purpose of this study is to evaluate the safety and effectiveness of ACRF surgery for treating DCKS. A multicenter prospective randomized controlled trial was designed. Eligible patients will be randomly divided into three groups, including the ACRF group, the conventional anterior surgery group, and the conventional posterior surgery group. Demographic data, surgery Information, and follow-up results will be collected and compared between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are diagnosed with degenerative cervical kyphosis with stenosis\n* Patients aged between 30 and 70 years\n* Patients meet the indications for surgery\n* Patients submitted written informed consent\n\nExclusion Criteria:\n\n* Tumor, infection, or trauma of the cervical spine\n* Severe cervical kyphosis that greater than 50°\n* Severe ossification of the posterior longitudinal ligament of the cervical spine\n* Patients with ankylosing spondylitis\n* Previous surgery of the cervical spine'}, 'identificationModule': {'nctId': 'NCT04806360', 'briefTitle': 'Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'Application of Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis：a Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2020YLCYJ-Y09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACRF group', 'description': 'ACRF is a new surgical procedure that previously proposed by our team, it combines the advantages of both the conventional anterior and posterior approach. Eligible patients in this group will receive ACRF surgery.', 'interventionNames': ['Procedure: ACRF surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional anterior surgery group', 'description': 'Eligible patients in this group will receive conventional anterior surgery, including anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.', 'interventionNames': ['Procedure: conventional anterior surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional posterior surgery group', 'description': 'Eligible patients in this group will receive conventional posterior surgery, including laminectomy and fusion surgery or laminoplasty surgery.', 'interventionNames': ['Procedure: conventional posterior surgery']}], 'interventions': [{'name': 'ACRF surgery', 'type': 'PROCEDURE', 'description': 'A new surgical procedure that previously proposed by our team.', 'armGroupLabels': ['ACRF group']}, {'name': 'conventional anterior surgery', 'type': 'PROCEDURE', 'description': 'Anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.', 'armGroupLabels': ['conventional anterior surgery group']}, {'name': 'conventional posterior surgery', 'type': 'PROCEDURE', 'description': 'Laminectomy and fusion surgery or laminoplasty surgery.', 'armGroupLabels': ['conventional posterior surgery group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200003', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Changzheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xuhua Lu, M.D.', 'role': 'CONTACT', 'email': 'xuhualu@hotmail.com', 'phone': '+862181885793'}, {'name': 'Bangke Zhang, M.D.', 'role': 'CONTACT', 'email': 'zbk12345@163.com', 'phone': '+8618301783716'}], 'overallOfficials': [{'name': 'Xuhua Lu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Changzheng Hospotal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Naval Specialty Medical Center, China', 'class': 'UNKNOWN'}, {'name': 'The NO.72 Army Hospital of Huzhou, China', 'class': 'UNKNOWN'}, {'name': "903 Hospital of Chinese People's Liberation Army", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Traumatic Orthopaedic Department', 'investigatorFullName': 'Xuhua Lu', 'investigatorAffiliation': 'Shanghai Changzheng Hospital'}}}}