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NCT01103752 Clinical Trial

Postoperative Cognitive Dysfunction After Total Knee or Hip Replacement Surgery in Fast-track Set-up

Postoperative Cognitive Dysfunction Clinical Trial

Official title:
Postoperative Cognitive Dysfunction After Total Knee or Hip Replacement Surgery in Fast-track Set-up

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01103752
Other study ID # H-3-2009-096
Secondary ID
Status Completed
Phase N/A
First received April 13, 2010
Last updated December 13, 2011
Start date October 2009
Est. completion date December 2011

Study information
Verified date December 2011
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial Summary

The aim of this study is to quantify the incidence of postoperative cognitive dysfunction in the elderly patient (>60y) after total hip or knee replacement surgery. The hypothesis is that the fast-track methodology with a mean hospital stay less than 3 days will help to minimize this reduction in memory and concentration.

Recruitment information / eligibility
Status Completed
Enrollment 225
Est. completion date December 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- 60 years of age or above

- ASA classification 1-4

- undergoing fast-track hip or knee replacement

Exclusion Criteria:

- anaesthesia within the past 90 days

- daily consumption of sleep or anxiety medication

- more than 35 units of alcohol per week

- lack of proper verbal and reading skills, Danish

- Serious hearing or visual impairment

- Mini mental status evaluation (MMSE) < 24

- Parkinsons Disease or other neurological disease causing functional impairment

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• no intervention, descriptive study
no intervention, descriptive study

Locations
Country Name City State
Denmark The Lundbeck Centre for fast-track hip/knee surgery Copenhagen

Sponsors (2)
Lead Sponsor Collaborator
Lene Krenk Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

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