Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-29 @ 11:19 PM
Study NCT ID:
NCT04133103
Status:
UNKNOWN
Last Update Posted:
2019-12-11
First Post:
2019-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Mobilisation in the Surgical Robot Assisted Spinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2019-10-13', 'studyFirstSubmitQcDate': '2019-10-17', 'lastUpdatePostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'preoperative', 'description': 'Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain.'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '4 hours postoperatively', 'description': 'Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain.'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '24 hours postoperatively', 'description': 'Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain.'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '3 months postoepratively', 'description': 'Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain.'}], 'secondaryOutcomes': [{'measure': 'Japanese Orthopedic Association', 'timeFrame': 'preoperative', 'description': 'The Japanese Orthopedic Association score was used to evaluate the neurological function of patients with lumbar degeneration and treatment effectiveness. The highest possible total score from categories for a normal person is 29 points. Therefore, treatment improvement rate = \\[(post-treatment score - pre-treatment score) / (29 - pre-treatment score)\\] × 100%, and ≥75% means excellent; 50%-74% means good; 25%-49% means fair; 0-24% means poor.'}, {'measure': 'Japanese Orthopedic Association', 'timeFrame': '3 months postoperatively', 'description': 'The Japanese Orthopedic Association score was used to evaluate the neurological function of patients with lumbar degeneration and treatment effectiveness. The highest possible total score from categories for a normal person is 29 points. Therefore, treatment improvement rate = \\[(post-treatment score - pre-treatment score) / (29 - pre-treatment score)\\] × 100%, and ≥75% means excellent; 50%-74% means good; 25%-49% means fair; 0-24% means poor.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': 'preoperative', 'description': 'The Oswestry Disability Index is one of the principal condition-specific outcome measures used in the management of spinal disorders. Rounding the percentage to a whole number is suggested for convenience. So the final score may be summarized as: \\[total score / (5 × number of questions answered)\\] × 100%. It is suggested rounding the percentage to a whole number for convenience. We defined that 0-20% means mild; 21%-40% means moderate; 41%-60% means severe; 61%-80% means very severe；80%-100% means patients very exaggerated symptoms.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '3 months postoperatively', 'description': 'The Oswestry Disability Index is one of the principal condition-specific outcome measures used in the management of spinal disorders. Rounding the percentage to a whole number is suggested for convenience. So the final score may be summarized as: \\[total score / (5 × number of questions answered)\\] × 100%. It is suggested rounding the percentage to a whole number for convenience. We defined that 0-20% means mild; 21%-40% means moderate; 41%-60% means severe; 61%-80% means very severe；80%-100% means patients very exaggerated symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early mobilisation', 'robot', 'spine', 'enhanced recovery'], 'conditions': ['Degenerative Disease', 'Fracture']}, 'descriptionModule': {'briefSummary': 'In this study, patients who underwent lumbar spine surgery in our hospital were included. A prospective study was conducted to investigate the effects of early mobilisation on postoperative complications, functual outcomes and patient satisfaction after robotic assisted lumbar spinal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of degenerative diseases or spinal fracture\n* single level instrumentation sugery\n* sign informed consent\n\nExclusion Criteria:\n\n* multilevel instrumentaion surgery\n* diagnosis of severe osteoperosis (BMD \\< 60mg/cm3) by QCT\n* coagulant function abnormality\n* severe internal disease\n* not suitable for inclusion'}, 'identificationModule': {'nctId': 'NCT04133103', 'briefTitle': 'Early Mobilisation in the Surgical Robot Assisted Spinal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Jishuitan Hospital'}, 'officialTitle': 'A Prospective Study of Early Mobilisation in the Surgical Robot Assisted Spinal Surgery', 'orgStudyIdInfo': {'id': 'Jilunke201909-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'First ambulation at 24 hours after operation'}, {'type': 'EXPERIMENTAL', 'label': 'First ambulation at 4 hours after operation', 'interventionNames': ['Procedure: first ambulation at 4 hour after operation']}], 'interventions': [{'name': 'first ambulation at 4 hour after operation', 'type': 'PROCEDURE', 'description': 'Two groups were conducted for first ambulation at 4 or 24 hours aftër operation', 'armGroupLabels': ['First ambulation at 4 hours after operation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100035', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Tian', 'role': 'CONTACT', 'email': 'tianwei2019@yeah.net'}], 'facility': 'Wei Tian', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wei Tian, MD', 'role': 'CONTACT', 'email': 'tianwei2019@yeah.net'}, {'name': 'Wei Tian', 'role': 'CONTACT', 'email': 'tianwei2019@yeah.net', 'phone': '010-58516959'}], 'overallOfficials': [{'name': 'Wei Tian', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijng Jishuitan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Jishuitan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of spine department', 'investigatorFullName': 'Wei Tian', 'investigatorAffiliation': 'Beijing Jishuitan Hospital'}}}}