Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-04 @ 9:35 PM
Study NCT ID:
NCT02576405
Status:
UNKNOWN
Last Update Posted:
2015-10-15
First Post:
2015-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychiatric Disorder and Postoperative Morbidity in Hip and Knee Artroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-14', 'studyFirstSubmitDate': '2015-10-13', 'studyFirstSubmitQcDate': '2015-10-14', 'lastUpdatePostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological characterization of hip and knee arthroplasty patients using the validated SCL-92 questionnaire', 'timeFrame': '90 days postoperatively'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': '90 days postoperatively'}, {'measure': 'Readmissions', 'timeFrame': '30 and 90 days postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Focus is on Preoperative Psychiatric Charactarization of Elective Fast-track Hip and Knee Arthroplasty Patients']}, 'descriptionModule': {'briefSummary': "It has been established that patients with psychiatric disorders tend to do worse in a surgical setting. Some types of surgery with greater impact than others, including orthopedic surgery. In our research group the investigators have shown this to be the case for hip and knee replacements within the mentioned patient category. However, the role of psychiatric disorder and use of different psychopharmacological drugs in relation to perioperative morbidity and mortality have not been thoroughly examined. The objective of this study is to shed light on the issue.\n\nRecent studies have shown that different types of psychiatric disorder influence surgical outcome differently. This emphasizes the need for specific knowledge regarding psychiatric diagnoses preoperatively. In this study around 2000 patients with or without psychiatric disorder of any kind will be studied preoperatively, which according to our previous study will include more than 200 patients receiving psychopharmacological treatment. The specifics that characterize every patient's psychiatric trades will be included in a validated questionnaire constructed for that purpose. The questionnaire is called SCL-92 and has been chosen in collaboration with Professor in Psychiatry, Rigshospitalet Anders Fink-Jensen. Preoperative information regarding their mental condition and medicine will be linked to surgical outcome in order to identify potential hazards in the perioperative period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Danish population sample (N=2000) of hip and knee arthroplasty patients in an elective fast-track setting.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients planned for elective unilateral fast-track hip or knee arthroplasty.\n* Age \\> 18.\n* Can understand and read danish.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02576405', 'briefTitle': 'Psychiatric Disorder and Postoperative Morbidity in Hip and Knee Artroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Characterization of Preoperative Psychiatric Disorder in Relation to Postoperative Morbidity in Elective Fast-Track Total Hip and Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'SG'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Silas Gylvin, MD', 'role': 'CONTACT', 'email': 'silasgylvin@gmail.com', 'phone': '+45 51 29 68 05'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Silas Hinsch Gylvin', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}