Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-04-03 @ 4:31 PM
Study NCT ID:
NCT02852460
Status:
UNKNOWN
Last Update Posted:
2016-08-02
First Post:
2016-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Rapid Recovery on Sleep Quality Following Total Hip Replacement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-07-28', 'studyFirstSubmitDate': '2016-07-24', 'studyFirstSubmitQcDate': '2016-07-28', 'lastUpdatePostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the pain, stiffness and joint function of operated limb by McMaster Universities Osteoarthritis Index(WOMAC)', 'timeFrame': '6 months', 'description': 'To evaluate the function and structure of hip joint from the aspect of pain, stiffness and joint function'}, {'measure': 'To evaluate the anxiety of patients post-operation by Generalized Anxiety Disorder scale-7 (GAD-7)', 'timeFrame': '6 months'}, {'measure': 'To evaluate the sleep quality of patients post-operation by Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '6 months'}, {'measure': 'Insomnia severity index', 'timeFrame': '6 months'}, {'measure': 'To evaluate the health related quality of life of patients post-operation by the 12-items Short Form Health Survey (SF-12)', 'timeFrame': '6 months'}, {'measure': 'To evaluate the pain severity of patients post-operation by Visual Analogue Scale (VAS) Pain Score', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'C Reactive Protein (CRP)', 'timeFrame': '6 months'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': '6 months'}, {'measure': 'To evaluate the quadriceps strength according to grade division standard published by British Medical Research Council', 'timeFrame': '6 months'}, {'measure': 'To evaluate the swelling of operated limb by measure the thigh girth increment', 'timeFrame': '6 months', 'description': 'Calculated by operated limb thigh girth increment post-operation'}, {'measure': 'To evaluate the operation satisfaction of patients by Visual Analogue Scale (VAS) Satisfaction Score', 'timeFrame': '6 months'}, {'measure': 'To evaluate the function of operated limb by Harris hip score (HHS)', 'timeFrame': '6 months'}, {'measure': 'To evaluate the range of motion (ROM) of operated hip', 'timeFrame': '6 months', 'description': 'ROM of operated hips post-operation'}, {'measure': 'Length of hospital stay', 'timeFrame': '3 months'}, {'measure': 'Number of dressing changes', 'timeFrame': '1 month', 'description': 'Number of dressing changes post-operation'}, {'measure': 'Hematocrit', 'timeFrame': '6 months', 'description': 'Pre-operation and post-operation hematocrit'}, {'measure': 'Haemoglobin', 'timeFrame': '6 months', 'description': 'Pre-operation and post-operation haemoglobin'}, {'measure': 'Number of Blood transfusion cases', 'timeFrame': '1 month'}, {'measure': 'Blood transfusion volume', 'timeFrame': '1 month'}]}, 'conditionsModule': {'conditions': ['Arthroplasty', 'Recovery of Function', 'Sleep Quality']}, 'descriptionModule': {'briefSummary': 'To evaluate the influence of rapid recovery on sleep quality following total hip replacement surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Primary unilateral total hip arthroplasty;\n* 2\\. Patients with hip osteoarthritis,rheumatoid arthritis or femoral head necrosis;\n* 3\\. Able and willing to provide signed informed consent.\n\nExclusion Criteria:\n\n* 1\\. Simultaneously bilateral total hip arthroplasty or revision case;\n* 2\\. Surgical History of the hip joint;\n* 3\\. Hip joint cavity paracentesis in recent 3 months;\n* 4\\. Stiffness with hip;\n* 5\\. Blood coagulation disorders;\n* 6\\. History of deep venous thrombosis;\n* 7\\. Concomitant medical problems such as uncontrolled hypertension, severe cardiovascular disorder, chronic obstructive pulmonary disease, liver or renal failure\n* 8\\. Allergic to NSAIDs, opioid analgesics, zolpidem\n* 9\\. Sleep apnea, Parkinson disease, dementia, depression\n* 10\\. Use of sedatives or hypnotics\n* 11\\. Unable to comply with polysomnographic measurement'}, 'identificationModule': {'nctId': 'NCT02852460', 'briefTitle': 'The Influence of Rapid Recovery on Sleep Quality Following Total Hip Replacement Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'orgStudyIdInfo': {'id': 'Rapid recovery'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'rapid recovery', 'interventionNames': ['Other: rapid recovery']}, {'type': 'NO_INTERVENTION', 'label': 'Controlled group', 'description': 'non-rapid recovery'}], 'interventions': [{'name': 'rapid recovery', 'type': 'OTHER', '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', 'role': 'CONTACT', 'email': 'weinanzeng@163.com', 'phone': '+8615023100103'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Liu Yang', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}