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Psychiatric Disorder and Postoperative Morbidity in Hip and Knee Artroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02576405
Recruitment Status : Unknown
Verified September 2015 by Silas Hinsch Gylvin, Rigshospitalet, Denmark.
Recruitment status was:  Not yet recruiting
First Posted : October 15, 2015
Last Update Posted : October 15, 2015
Information provided by (Responsible Party):
Silas Hinsch Gylvin, Rigshospitalet, Denmark

Brief Summary:

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.

Recent 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.

Condition or disease
Focus is on Preoperative Psychiatric Charactarization of Elective Fast-track Hip and Knee Arthroplasty Patients

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Preoperative Psychiatric Disorder in Relation to Postoperative Morbidity in Elective Fast-Track Total Hip and Knee Arthroplasty
Study Start Date : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Psychological characterization of hip and knee arthroplasty patients using the validated SCL-92 questionnaire [ Time Frame: 90 days postoperatively ]

Secondary Outcome Measures :
  1. Length of stay [ Time Frame: 90 days postoperatively ]
  2. Readmissions [ Time Frame: 30 and 90 days postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Danish population sample (N=2000) of hip and knee arthroplasty patients in an elective fast-track setting.

Inclusion Criteria:

  • All patients planned for elective unilateral fast-track hip or knee arthroplasty.
  • Age > 18.
  • Can understand and read danish.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02576405

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Contact: Silas Gylvin, MD +45 51 29 68 05

Sponsors and Collaborators
Rigshospitalet, Denmark
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Responsible Party: Silas Hinsch Gylvin, Medical Doctor, Rigshospitalet, Denmark Identifier: NCT02576405    
Other Study ID Numbers: SG
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Mental Disorders
Problem Behavior
Behavioral Symptoms