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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014