Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-30 @ 12:20 AM
Study NCT ID:
NCT05006495
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2021-07-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D017887', 'term': 'Ossification of Posterior Longitudinal Ligament'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009999', 'term': 'Ossification, Heterotopic'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'junhiya@snu.ac.kr', 'phone': '+821049051485', 'title': 'Researcher of Clinical Trials', 'organization': 'Seoul National University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.", 'eventGroups': [{'id': 'EG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.\n\nC3 laminoplasty: Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'C2-C7 Lordosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'OG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring C2-C7 lordosis angle by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.', 'unitOfMeasure': '°', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'the Neck Disability Index (NDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'OG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'scores from 0 to 50 with 50 being the worst performance status related to neck pain.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'C2-C3 Lordosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'OG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring C2-C3 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.', 'unitOfMeasure': '°', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'C4-C7 Lordosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'OG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring C4-C7 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.', 'unitOfMeasure': '°', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cervical Sagittal Vertical Axis (cSVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'OG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring cervical sagittal vertical axis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'T1 Slope', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'OG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring T1 slope by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.', 'unitOfMeasure': '°', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'T1 Slope Minus Cervical Lordosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'OG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring T1 slope minus cervical lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.', 'unitOfMeasure': '°', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'C2-C3 Interlaminar Spontaneous Fusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'OG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 2 year', 'description': 'Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EuroQol Five-dimensional Questionnaire (EQ-5D) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'OG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.661', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '0.743', 'spread': '0.024', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Responses on a questionnaire with five dimensions, each comprised of five levels. Scores are revised into an index with a range from -0.59-1, with 1.00 indicating full health. The 243 possible health states on the EQ-5D are evaluated against a normal population using the time trade off method (TTO).', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Posterior Neck With Numering Rating Scale (NRS-N)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'OG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring pain intensity of the posterior neck with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Upper Limb Pain With Numering Rating Scale (NRS-L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'OG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring pain intensity of the upper limb with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Estimated Intraoperative Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'OG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '169', 'spread': '145', 'groupId': 'OG000'}, {'value': '182', 'spread': '159', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative', 'description': 'Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists.', 'unitOfMeasure': 'cc', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'OG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.'}], 'classes': [{'categories': [{'measurements': [{'value': '126', 'spread': '42', 'groupId': 'OG000'}, {'value': '118', 'spread': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative', 'description': 'Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'who completed 1-year to 3-year follow-up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'FG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.\n\nC3 laminoplasty: Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'C3 Laminectomy With C4-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.\n\nC3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.'}, {'id': 'BG001', 'title': 'C3-6 Laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.\n\nC3 laminoplasty: Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.9', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '58.3', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Disease', 'classes': [{'title': 'Cerivcal spondylotic myelopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Ossification of posterior longitudinal ligament', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '25.5', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '25.3', 'spread': '3.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'patients with more than postoperative 1year follow up were analysed.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-05', 'size': 447103, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-09T01:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Using a generator of www.randomization.com, 100 subjects randomized into blocks of 50 and 50. To reproduce this plan, use the seed 3169 along with the number of subjects per block/number of blocks and (case-sensitive) treatment labels as entered originally.\n\nand (case-sensitive) treatment labels as entered originally. After randomization of 100 subjects, additional 26 subjects randomized into blocks of 13 and13. To reproduce this plan, use the seed 5134 along with the number of subjects per block/number of blocks and (case-sensitive) treatment labels as entered originally.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized controlled trial, assigning subjects to two groups: C3 laminectomy with laminoplasty and C3-6 laminoplasty'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-09', 'studyFirstSubmitDate': '2021-07-30', 'resultsFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2021-08-08', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-09', 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C2-C7 Lordosis', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring C2-C7 lordosis angle by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.'}, {'measure': 'the Neck Disability Index (NDI)', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'scores from 0 to 50 with 50 being the worst performance status related to neck pain.'}], 'secondaryOutcomes': [{'measure': 'C2-C3 Lordosis', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring C2-C3 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.'}, {'measure': 'C4-C7 Lordosis', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring C4-C7 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.'}, {'measure': 'Cervical Sagittal Vertical Axis (cSVA)', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring cervical sagittal vertical axis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.'}, {'measure': 'T1 Slope', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring T1 slope by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.'}, {'measure': 'T1 Slope Minus Cervical Lordosis', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring T1 slope minus cervical lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.'}, {'measure': 'C2-C3 Interlaminar Spontaneous Fusion', 'timeFrame': 'at 2 year', 'description': 'Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series.'}, {'measure': 'EuroQol Five-dimensional Questionnaire (EQ-5D) Scores', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Responses on a questionnaire with five dimensions, each comprised of five levels. Scores are revised into an index with a range from -0.59-1, with 1.00 indicating full health. The 243 possible health states on the EQ-5D are evaluated against a normal population using the time trade off method (TTO).'}, {'measure': 'Posterior Neck With Numering Rating Scale (NRS-N)', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring pain intensity of the posterior neck with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.'}, {'measure': 'Upper Limb Pain With Numering Rating Scale (NRS-L)', 'timeFrame': 'at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)', 'description': 'Measuring pain intensity of the upper limb with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.'}, {'measure': 'Estimated Intraoperative Blood Loss', 'timeFrame': 'Intraoperative', 'description': 'Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists.'}, {'measure': 'Operative Time', 'timeFrame': 'Intraoperative', 'description': 'Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laminoplasty', 'Laminectomy'], 'conditions': ['Myelopathy Cervical', 'Kyphosis Post Surgical', 'Neck Pain', 'Ossification of Posterior Longitudinal Ligament', 'Cervical Spondylosis With Myelopathy']}, 'referencesModule': {'references': [{'pmid': '32387294', 'type': 'BACKGROUND', 'citation': 'Chen C, Li J, Liao Z, Gao Y, Shao Z, Yang C. C3 laminectomy combined with modified unilateral laminoplasty and in situ reconstruction of the midline structures maintained cervical sagittal balance: a retrospective matched-pair case-control study. Spine J. 2020 Sep;20(9):1403-1412. doi: 10.1016/j.spinee.2020.04.023. Epub 2020 May 6.'}, {'pmid': '32941312', 'type': 'BACKGROUND', 'citation': 'Kudo H, Takeuchi K, Wada K, Kumagai G, Tanaka S, Asari T, Araki R, Yokoyama T, Ishibashi Y. Ten-Year Long-term Results of Modified Cervical Double-door Laminoplasty With C3 Laminectomy Preserving the Semispinalis Cervicis Inserted Into the Axis Compared With Those of Conventional Cervical Laminoplasty. Clin Spine Surg. 2021 Apr 1;34(3):E147-E153. doi: 10.1097/BSD.0000000000001068.'}, {'pmid': '33086255', 'type': 'BACKGROUND', 'citation': 'Nakajima K, Nakamoto H, Kato S, Doi T, Matsubayashi Y, Taniguchi Y, Yoshida Y, Kawamura N, Nakarai H, Higashikawa A, Tozawa K, Takeshita Y, Fukushima M, Iizuka M, Ono T, Shirokoshi T, Azuma S, Tanaka S, Oshima Y. A Multicenter Observational Study on the Postoperative Outcomes of C3 Laminectomy in Cervical Double-door Laminoplasty. Clin Spine Surg. 2021 May 1;34(4):146-152. doi: 10.1097/BSD.0000000000001100.'}, {'pmid': '27851661', 'type': 'BACKGROUND', 'citation': 'Lee GW, Cho CW, Shin JH, Ahn MW. Which Technique Is Better Option for C3 Segment in Multilevel Open-Door Laminoplasty of the Cervical Spine?: Laminectomy Versus Laminoplasty. Spine (Phila Pa 1976). 2017 Jul 15;42(14):E833-E840. doi: 10.1097/BRS.0000000000001974.'}, {'pmid': '16284593', 'type': 'BACKGROUND', 'citation': 'Takeuchi K, Yokoyama T, Aburakawa S, Saito A, Numasawa T, Iwasaki T, Itabashi T, Okada A, Ito J, Ueyama K, Toh S. Axial symptoms after cervical laminoplasty with C3 laminectomy compared with conventional C3-C7 laminoplasty: a modified laminoplasty preserving the semispinalis cervicis inserted into axis. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2544-9. doi: 10.1097/01.brs.0000186332.66490.ba.'}]}, 'descriptionModule': {'briefSummary': 'Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.', 'detailedDescription': "Cervical laminoplasty is widely performed surgical techniques to cervical myelopathy patients. But it is well known that C3-6 Cervical laminoplasty often results in injury of the semispinalis cervicis inserted into the axis, which possibly causes postoperative cervical kyphosis and neck pain. C3 laminectomy with cervical laminoplasty is the modified technique preserving the semispinalis cervicis to reduce such complications of conventional C3-6 laminoplasty.\n\nThere has been a number of retrospective studies comparing C3 laminectomy with laminoplasty and C3-6 laminoplasty, however, there's no prospective randomized controlled study yet. Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty. Primary end points include the C2-7 spine cobb anlge, Neck Disability Index(NDI) at postoperative 1\\~3 year"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cervical stenosis patients with or without cervical myelopathy.\n\nExclusion Criteria:\n\n* Metastatic cancer patients.\n* Any combined fracture.\n* Previous surgery to cervical spine.\n* inflammatory joint disease\n* psychiatric illness'}, 'identificationModule': {'nctId': 'NCT05006495', 'briefTitle': 'Comparison Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Open Door Laminoplasty and C3 Laminectomy With Cervical Laminoplasty', 'orgStudyIdInfo': {'id': '1610-136-804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C3 laminectomy with C4-6 laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.', 'interventionNames': ['Procedure: C3 laminectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C3-6 laminoplasty', 'description': 'Cervical myelopathy patients who underwent C3-6 laminoplasty.', 'interventionNames': ['Procedure: C3 laminoplasty']}], 'interventions': [{'name': 'C3 laminectomy', 'type': 'PROCEDURE', 'description': 'C3 laminectomy preserving semispinalis cervicis inserted into the axis.', 'armGroupLabels': ['C3 laminectomy with C4-6 laminoplasty']}, {'name': 'C3 laminoplasty', 'type': 'PROCEDURE', 'description': 'Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.', 'armGroupLabels': ['C3-6 laminoplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chun Kee Chung, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chun Kee Chung', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}