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

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Lene Krenk, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01103752
First received: April 13, 2010
Last updated: December 13, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Postoperative Cognitive Dysfunction
 Other: no intervention, descriptive study

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Postoperative Cognitive Dysfunction After Total Knee or Hip Replacement Surgery in Fast-track Set-up

Resource links provided by NLM:

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Enrollment: 225
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Surgery
This group (n=220) consist of patients undergoing hip or knee replacement in a fast-track setup and they are tested 3 times for postoperative cognitive dysfunction.
 Other: no intervention, descriptive study
no intervention, descriptive study

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients undergoing fast-track knee or hip replacement surgery at one of the hospitals participating (Hidovre, Holstebro, Hørsholm, Århus)

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103752

Locations
Denmark
The Lundbeck Centre for fast-track hip/knee surgery
Copenhagen, Denmark
Sponsors and Collaborators
Lene Krenk
Lundbeck Foundation
Investigators
Principal Investigator: Lene Krenk, Doctor Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Lene Krenk, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01103752     History of Changes
Other Study ID Numbers: H-3-2009-096
Study First Received: April 13, 2010
Last Updated: December 13, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013