Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-25 @ 3:53 AM
Study NCT ID:
NCT04175535
Status:
UNKNOWN
Last Update Posted:
2020-12-29
First Post:
2019-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparative Study of Full-Endoscopic Cervical Posterior Discectomy and Anterior Cervical Decompression and Fusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D050939', 'term': 'Gene Fusion'}], 'ancestors': [{'id': 'D011995', 'term': 'Recombination, Genetic'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants were unaware of the grouping process. The surgeons were unaware of the grouping process. The follow-up recorders were unaware of the grouping process.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 308}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-27', 'studyFirstSubmitDate': '2019-10-17', 'studyFirstSubmitQcDate': '2019-11-22', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement rate', 'timeFrame': 'Follow up for 5 years', 'description': 'M-JOA Scoring'}], 'secondaryOutcomes': [{'measure': 'Basic information of participants', 'timeFrame': 'Follow up for 5 years', 'description': 'Age in year, gender in male or female, occupation'}, {'measure': 'Basic information of participants', 'timeFrame': 'Follow up for 5 years', 'description': 'weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Imaging examination', 'timeFrame': 'Follow up for 5 years', 'description': 'Cervical cobb angle change i'}, {'measure': 'Pain Assessment', 'timeFrame': 'Follow up for 5 years', 'description': 'VAS Score'}, {'measure': 'Operation duration', 'timeFrame': 'intraoperative', 'description': 'Operation duration in minute'}, {'measure': 'Amount of bleeding during operation', 'timeFrame': 'Follow up for 5 years', 'description': 'Amount of bleeding during operation in milliliter'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical disc herniation', 'endoscope', 'posterior', 'minimally invasive spine surgery'], 'conditions': ['M-JOA Score']}, 'descriptionModule': {'briefSummary': 'Anterior cervical decompression and fusion is the standard procedure for operation of cervical disc herniations. Mobility-preserving Full-Endoscopic Cervical Posterior discectomy is the most common alternative in the case of soft localization of the pathology. Endoscopic techniques are considered standard in many areas, since they may offer advantages in surgical technique and rehabilitation. These days, all disc herniations can be operated in full-endoscopic technique. With the full-endoscopic posterior cervical discectomy a procedures is available for cervical disc operations.', 'detailedDescription': "Investigators conducted a differential, randomized, 1:1, double-blind clinical control trial to compare the clinical effect, safety and feasibility of Full-Endoscopic Cervical Posterior discectomy and Anterior cervical decompression and fusion. The study was conducted in three centers at the same time, including the Second Affiliated Hospital of Zhejiang University Medical College, Zhejiang Provincial People's Hospital and Ningbo University Medical College Affiliated Hospital. This study is expected to include 308 patients with single level soft cervical disc herniation.Participants were randomly assigned to different groups for corresponding surgical intervention after complete preoperative evaluation.Participants received a standard 5-year follow-up procedure"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Single cervical intervertebral dis herniation wih symptoms of radicular pain or spinal cord compression ; 2) the herniated lesions had no obvious calcification; 3) conservative treatment fails ; 4) mild myelopathy (Nurick grade 3 or blow. (6) patients agree to participate in this study.\n\nExclusion Criteria:\n\n1. cervical segmental instability or deformity (cervical spondylolisthesis or Cobb Angle greater than 25°); 2) multisegmental lesions (≥2); 3) tumor, infection or other unknown space occupying in cervical vertebra; 4) surgical history of the target segment; 5) severe myelopathy (Nurick grade 4 or above); 6) the patients were not suitable for surgery, had poor medical management or did not agree to participate in this study.'}, 'identificationModule': {'nctId': 'NCT04175535', 'acronym': 'PPECD', 'briefTitle': 'The Comparative Study of Full-Endoscopic Cervical Posterior Discectomy and Anterior Cervical Decompression and Fusion', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'The Comparative Study of Full-Endoscopic Cervical Posterior Discectomy and Anterior Cervical Decompression and Fusion for the Operation of Soft Cervical Disc Herniation.', 'orgStudyIdInfo': {'id': 'zeyy1985811'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'The experimental group', 'description': 'PPECD was performed in the experimental group', 'interventionNames': ['Procedure: Percutaneous Posterior Endoscopic Cervical Discectomy']}, {'type': 'OTHER', 'label': 'control group', 'description': 'ACDF was performed in the control group', 'interventionNames': ['Procedure: Anterior cervical decompression and fusion']}], 'interventions': [{'name': 'Percutaneous Posterior Endoscopic Cervical Discectomy', 'type': 'PROCEDURE', 'description': 'The most common alternative in the case of soft cervical disc herniations.', 'armGroupLabels': ['The experimental group']}, {'name': 'Anterior cervical decompression and fusion', 'type': 'PROCEDURE', 'description': 'The standard procedure for operation of cervical disc herniations.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongjian Zhu, PhD', 'role': 'CONTACT', 'email': 'Neurosurgery@zju.edu.cn', 'phone': '13588881949'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}