Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-07-08 @ 6:18 PM
Study NCT ID:
NCT02845960
Status:
UNKNOWN
Last Update Posted:
2016-07-27
First Post:
2016-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Rapid Recovery on Sleep Quality Following Total Knee Replacement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-07-26', 'studyFirstSubmitDate': '2016-07-23', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC score', 'timeFrame': '1 mounth'}, {'measure': 'GAD-7', 'timeFrame': '1 mounth'}, {'measure': 'PSQI index', 'timeFrame': '1 mounth'}, {'measure': 'Insomnia severity index', 'timeFrame': '1 mounth'}, {'measure': 'polysomnographic measurement', 'timeFrame': '1 mounth'}, {'measure': 'VAS', 'timeFrame': '1 mounth'}, {'measure': 'Range of motion', 'timeFrame': '1 mounth'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthroplasty, Replacement, Knee', 'Recovery of Function', 'Arthritis, Rheumatoid']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the influence of rapid recovery on sleep quality following total knee replacement surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Primary unilateral total knee artropasty;\n2. Patients with Knee osteoartritis or Rheumatoid arthritis;\n3. Able and willing to provide signed informed consent.\n\nExclusion Criteria:\n\n1. Simultaneously bilateral total knee artropasty or revision case;\n2. Surgical History of the knee joint;\n3. Knee joint cavity paracentesis in recent 3 months;\n4. Stiffness with knee;\n5. Blood coagulation disorders;\n6. History of deep venous thrombosis;\n7. Concomitant medical problems such as uncontrolled hypertention, severe cardiovascular disorder, chronic obstructive pulmonary disease, liver or renal failure\n8. allergic to NSAIDs, opioid analgesics, zolpidem\n9. sleep apnea, Parkinson disease, dementia, depression\n10. use of sedatives or hypnotics\n11. inability to comply with polysomnographic measurement'}, 'identificationModule': {'nctId': 'NCT02845960', 'briefTitle': 'The Influence of Rapid Recovery on Sleep Quality Following Total Knee Replacement Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'orgStudyIdInfo': {'id': 'Southwest Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group', 'description': 'rapid recovery', 'interventionNames': ['Behavioral: rapid recovery']}, {'label': 'Controlled group', 'description': 'no rapid recovery'}], 'interventions': [{'name': 'rapid recovery', 'type': 'BEHAVIORAL', 'description': 'rapid recovery', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weinan Zeng, doctor', 'role': 'CONTACT', 'email': 'weinanzeng@163.com', 'phone': '+8615023100103'}], 'facility': 'Southwest Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'WEINAN ZENG, Doctor', 'role': 'CONTACT', 'email': 'weinanzeng@163.com', 'phone': '+8615023100103'}, {'name': 'JUNLI LIU, Doctor', 'role': 'CONTACT', 'email': 'tmmuljl@163.com', 'phone': '8613452067520'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Liu Yang', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}