Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2026-02-27 @ 12:24 PM
Study NCT ID:
NCT02416934
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dysphagia Following Anterior Cervical Spine Surgery; Steroid vs Saline
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'semery@hsc.wvu.edu', 'phone': '304-293-1170', 'title': 'Dr. Sanford Emery', 'organization': 'West Virginia University Department of Orthopaedics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 1 year', 'description': 'Other not including serious adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment 1; Dexamethasone', 'description': "Swallowing difficulty. Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score is calculated by summing up the points given for each item to a maximum of 18 points, where lower scores represent milder symptoms (zero indicates no symptoms) and vice versa. For the Bazaz score, symptoms are measured as 'none', 'mild', 'moderate', or 'severe'. Zero indicates none or no symptoms, 1 indicates mild, 2 indicates moderate, 3 indicates severe. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are reported.", 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment 0; Saline Placebo', 'description': "Swallowing difficulty. Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score is calculated by summing up the points given for each item to a maximum of 18 points, where lower scores represent milder symptoms (zero indicates no symptoms) and vice versa. For the Bazaz score, symptoms are measured as 'none', 'mild', 'moderate', or 'severe'. Zero indicates none or no symptoms, 1 indicates mild, 2 indicates moderate, 3 indicates severe. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are reported.", 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'intraoperative musculoskeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'intraoperative neurological injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Swallowing Difficulty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone DSQ', 'description': 'Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.\n\nPatients were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone.\n\nTreatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.'}, {'id': 'OG001', 'title': 'Saline Placebo DSQ', 'description': 'Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.\n\nPatients were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline.\n\nTreatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.'}, {'id': 'OG002', 'title': 'Dexamethasone Bazaz', 'description': 'Treatment 1; Dexamethasone. Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.\n\nPatients were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone.\n\nTreatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.'}, {'id': 'OG003', 'title': 'Saline Placebo Bazaz', 'description': 'Treatment 0; Saline Placebo. Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.\n\nPatients were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline.\n\nTreatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.'}], 'classes': [{'title': 'Difficulty swallowing Baseline', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Difficulty swallowing day 1', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}, {'title': 'Difficulty swallowing day 2', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'Difficulty swallowing Week 1', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}, {'title': 'Difficulty swallowing Week 2', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': 'Difficulty swallowing Month 1', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Difficulty swallowing Month 3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Difficulty swallowing Month 6', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Difficulty swallowing Month 12', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5392', 'ciLowerLimit': '-2.9761', 'ciUpperLimit': '-.1022', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.7176', 'groupDescription': 'Comparing DSQ between Dexamethasone and Saline at Day 1 post-op', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.6040', 'ciLowerLimit': '-1.1151', 'ciUpperLimit': '-.0930', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.2543', 'groupDescription': 'Comparing Bazaz between Dexamethasone and Saline at 6 months post-op', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months', 'description': 'Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score of zero indicates no symptoms. Any number above zero indicates difficulty swallowing. The Bazaz score of Zero indicates no symptoms. Any number above zero indicates difficulty swallowing. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are listed below associated with the randomization assignment and survey used.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment 1; Dexamethasone or Treatment 0; Saline placebo. Treatment 1 received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. Dosage was approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 0 received similar volume of saline on same schedule for three doses.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Change in Quality of Life Dexamethasone', 'description': 'Change in quality of life from baseline to 1 year (or last visit as appropriate). Not all subjects came for 1 year follow up.'}, {'id': 'OG001', 'title': 'Change in Quality of Life Saline Placebo', 'description': 'Change in quality of life from baseline to 1 year (or last visit as appropriate.) Not all subjects came for 1 year follow up.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.1208', 'spread': '3.1273', 'groupId': 'OG000'}, {'value': '-7.9082', 'spread': '3.1273', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7874', 'ciLowerLimit': '-4.5153', 'ciUpperLimit': '8.0902', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.1273', 'groupDescription': 'Comparing the changes in VNDI between Dexamethasone and Saline from baseline to last visit', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year.', 'description': 'Change in Quality of life measured by the Neck Disability Index (NDI) from baseline and 1 year for Treatment 1; Dexamethasone and Treatment 0; Saline placebo. The NDI measures self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is 50. The higher the score the more disability. The scale is 0 - 4 = no disability; 5 - 14 = mild;15 - 24 = moderate; 25 - 34 = severe; above 34 = complete disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Neck Disability Index change from baseline to 1 year or last visit as appropriate. Not all subjects followed up at 1 year.'}, {'type': 'SECONDARY', 'title': 'Fusion Rate Steroid vs Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Fusion', 'description': 'Fused if radiographs demonstrated less than 1 millimeter of interspinous motion between flexion and extension,7 or if CT/MRI demonstrated clear evidence of bone bridging from endplate to endplate.'}, {'id': 'OG001', 'title': 'Saline Fusion', 'description': 'Fused if radiographs demonstrated less than 1 millimeter of interspinous motion between flexion and extension,7 or if CT/MRI demonstrated clear evidence of bone bridging from endplate to endplate.'}], 'classes': [{'categories': [{'title': 'unknown', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'fused', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'not fused', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.375', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "Fisher's Exact Test", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Participants were considered fused if radiographs demonstrated less than 1 millimeter of interspinous motion between flexion and extension,7 or if CT/MRI demonstrated clear evidence of bone bridging from endplate to endplate.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment 1; Dexamethasone', 'description': 'Swallowing difficulty at various time points as measured by the DSQ and Bazaz for subjects randomized to Treatment 1; Dexamethasone'}, {'id': 'FG001', 'title': 'Treatment 0; Saline Placebo', 'description': 'Swallowing difficulty at various time points as measured by the DSQ and Bazaz for subjects randomized to Treatment 0; Saline placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Double Blind (0-52 Weeks)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Last Participant Completed 1 yr', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'given steroids', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'recruited during continuing renewal proc', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'surgery started late', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 're-operation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Potential participants undergoing elective anterior cervical spine surgery will be seen by spine surgeons at the WVU Spine Center. Participants will be told about the study and given the opportunity to consent. Consented participants will be randomized to either the steroid administration group or the saline administration group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment 1; Dexamethasone', 'description': 'Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.\n\nPatients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.\n\nTreatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.'}, {'id': 'BG001', 'title': 'Treatment 0; Saline Placebo', 'description': 'Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.\n\nPatients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.\n\nTreatment 0; Saline placebo: Saline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Ten total subjects were removed from the study for various reasons.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz) were administered in person at baseline and Day 1, via phone call Day 2, Week 1,2; 1,3, 6 months, and 1 year.', 'unitOfMeasure': 'participants'}], 'populationDescription': "Ten participant's data was not analyzed for various reasons."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-05-28', 'size': 151219, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-27T12:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-15', 'studyFirstSubmitDate': '2015-01-09', 'resultsFirstSubmitDate': '2017-12-06', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-28', 'studyFirstPostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Swallowing Difficulty', 'timeFrame': '1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months', 'description': 'Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score of zero indicates no symptoms. Any number above zero indicates difficulty swallowing. The Bazaz score of Zero indicates no symptoms. Any number above zero indicates difficulty swallowing. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are listed below associated with the randomization assignment and survey used.'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year.', 'description': 'Change in Quality of life measured by the Neck Disability Index (NDI) from baseline and 1 year for Treatment 1; Dexamethasone and Treatment 0; Saline placebo. The NDI measures self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is 50. The higher the score the more disability. The scale is 0 - 4 = no disability; 5 - 14 = mild;15 - 24 = moderate; 25 - 34 = severe; above 34 = complete disability.'}, {'measure': 'Fusion Rate Steroid vs Placebo', 'timeFrame': '1 year', 'description': 'Participants were considered fused if radiographs demonstrated less than 1 millimeter of interspinous motion between flexion and extension,7 or if CT/MRI demonstrated clear evidence of bone bridging from endplate to endplate.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dysphagia']}, 'referencesModule': {'references': [{'pmid': '20407354', 'type': 'BACKGROUND', 'citation': 'Riley LH 3rd, Vaccaro AR, Dettori JR, Hashimoto R. Postoperative dysphagia in anterior cervical spine surgery. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S76-85. doi: 10.1097/BRS.0b013e3181d81a96.'}, {'pmid': '18091507', 'type': 'BACKGROUND', 'citation': 'Fountas KN. Re: Papavero L, Heese O, Klotz-Regener V, et al. The impact of esophagus retraction on early dysphagia after anterior cervical surgery. Spine 2007;32:1089-93. Spine (Phila Pa 1976). 2007 Dec 15;32(26):3090. doi: 10.1097/BRS.0b013e31815cd40f. No abstract available.'}, {'pmid': '18245583', 'type': 'BACKGROUND', 'citation': 'Mendoza-Lattes S, Clifford K, Bartelt R, Stewart J, Clark CR, Boezaart AP. Dysphagia following anterior cervical arthrodesis is associated with continuous, strong retraction of the esophagus. J Bone Joint Surg Am. 2008 Feb;90(2):256-63. doi: 10.2106/JBJS.G.00258.'}, {'pmid': '19929356', 'type': 'BACKGROUND', 'citation': 'Cavusoglu H, Tuncer C, Tanik C, Mutlu Z, Zengin E, Karabagli M, Aydin Y. The impact of automatic retractors on the esophagus during anterior cervical surgery: an experimental in vivo study in a sheep model. J Neurosurg Spine. 2009 Nov;11(5):547-54. doi: 10.3171/2009.6.SPINE09216.'}, {'pmid': '17321961', 'type': 'BACKGROUND', 'citation': 'Lee MJ, Bazaz R, Furey CG, Yoo J. Risk factors for dysphagia after anterior cervical spine surgery: a two-year prospective cohort study. Spine J. 2007 Mar-Apr;7(2):141-7. doi: 10.1016/j.spinee.2006.02.024. Epub 2007 Jan 22.'}, {'pmid': '21140251', 'type': 'BACKGROUND', 'citation': 'Rihn JA, Kane J, Albert TJ, Vaccaro AR, Hilibrand AS. What is the incidence and severity of dysphagia after anterior cervical surgery? Clin Orthop Relat Res. 2011 Mar;469(3):658-65. doi: 10.1007/s11999-010-1731-8.'}, {'pmid': '21785303', 'type': 'BACKGROUND', 'citation': 'Siska PA, Ponnappan RK, Hohl JB, Lee JY, Kang JD, Donaldson WF 3rd. Dysphagia after anterior cervical spine surgery: a prospective study using the swallowing-quality of life questionnaire and analysis of patient comorbidities. Spine (Phila Pa 1976). 2011 Aug 1;36(17):1387-91. doi: 10.1097/BRS.0b013e31822340f2.'}, {'pmid': '21798743', 'type': 'BACKGROUND', 'citation': 'Kang SH, Kim DK, Seo KM, Kim KT, Kim YB. Multi-level spinal fusion and postoperative prevertebral thickness increase the risk of dysphagia after anterior cervical spine surgery. J Clin Neurosci. 2011 Oct;18(10):1369-73. doi: 10.1016/j.jocn.2011.02.033. Epub 2011 Jul 27.'}, {'pmid': '12435974', 'type': 'BACKGROUND', 'citation': 'Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. doi: 10.1097/00007632-200211150-00007.'}, {'pmid': '16284596', 'type': 'BACKGROUND', 'citation': 'Riley LH 3rd, Skolasky RL, Albert TJ, Vaccaro AR, Heller JG. Dysphagia after anterior cervical decompression and fusion: prevalence and risk factors from a longitudinal cohort study. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2564-9. doi: 10.1097/01.brs.0000186317.86379.02.'}, {'pmid': '12592551', 'type': 'BACKGROUND', 'citation': 'Pedram M, Castagnera L, Carat X, Macouillard G, Vital JM. Pharyngolaryngeal lesions in patients undergoing cervical spine surgery through the anterior approach: contribution of methylprednisolone. Eur Spine J. 2003 Feb;12(1):84-90. doi: 10.1007/s00586-002-0495-6. Epub 2002 Dec 4.'}, {'pmid': '19148042', 'type': 'BACKGROUND', 'citation': 'Emery SE, Akhavan S, Miller P, Furey CG, Yoo JU, Rowbottom JR, Bohlman HH. Steroids and risk factors for airway compromise in multilevel cervical corpectomy patients: a prospective, randomized, double-blind study. Spine (Phila Pa 1976). 2009 Feb 1;34(3):229-32. doi: 10.1097/BRS.0b013e318193a287.'}, {'pmid': '22020609', 'type': 'BACKGROUND', 'citation': 'Lee SH, Kim KT, Suk KS, Park KJ, Oh KI. Effect of retropharyngeal steroid on prevertebral soft tissue swelling following anterior cervical discectomy and fusion: a prospective, randomized study. Spine (Phila Pa 1976). 2011 Dec 15;36(26):2286-92. doi: 10.1097/BRS.0b013e318237e5d0.'}]}, 'descriptionModule': {'briefSummary': 'This prospective, randomized, double blind, controlled study evaluates the effect of perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.', 'detailedDescription': 'This investigation is a prospective, randomized, double-blind, controlled trial testing peri-operative steroids versus saline and the effect on swallowing after anterior cervical spine surgery. Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale and the Dysphagia Short Questionnaire (DSQ). Swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. Patient clinical outcomes will be captured using web-based progress reports. Patients will complete the Quality of Life (QoL-12), Neck Disability Index (NDI), and Visual Analog Scale (VAS) questionnaires electronically pre-operatively and at one year post-operatively. This outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective anterior approach to subaxial cervical spine (C3 - T1);\n* ages 18-80\n\nExclusion Criteria:\n\n* Traumatic or tumor etiologies\n* undergoing anterior-posterior operations\n* neoplastic, or infectious conditions requiring surgery\n* a history of previous anterior cervical spine surgery\n* any patient requiring a halo vest\n* patients on chronic steroids\n* patients remaining intubated post-operatively (please see more under risks below)\n* less than 18 years of age\n* pregnant women\n* no phone'}, 'identificationModule': {'nctId': 'NCT02416934', 'acronym': 'DysDexVSSal', 'briefTitle': 'Dysphagia Following Anterior Cervical Spine Surgery; Steroid vs Saline', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': 'The Effects of Perioperative Steroids on Dysphagia Following Anterior Cervical Spine Surgery: A Randomized, Prospective, Double-Blind Study.', 'orgStudyIdInfo': {'id': '1405296745'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment 1; Dexamethasone', 'description': 'Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.\n\nPatients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.', 'interventionNames': ['Drug: Treatment 1; Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment 0; Saline placebo', 'description': 'Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.\n\nPatients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.', 'interventionNames': ['Drug: Treatment 0; Saline placebo']}], 'interventions': [{'name': 'Treatment 1; Dexamethasone', 'type': 'DRUG', 'otherNames': ['Steroid'], 'description': 'Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.', 'armGroupLabels': ['Treatment 1; Dexamethasone']}, {'name': 'Treatment 0; Saline placebo', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Saline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.', 'armGroupLabels': ['Treatment 0; Saline placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Sanford E Emery, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Virginia University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Within one year of study completion', 'ipdSharing': 'YES', 'description': 'Group data will be available via publication. Participants are told their randomization assignment at one year, or up to two year, follow up post surgery, dependent on their return to clinic.', 'accessCriteria': 'Through a published manuscript and to participants via phone call or clinic visit when the participants return for regularly scheduled follow up visits.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Virginia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair West Virginia University Department of Orthopaedics', 'investigatorFullName': 'Sanford E Emery, MD, MBA', 'investigatorAffiliation': 'West Virginia University'}}}}