NCT01103752

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 14, 2011

Status Verified

December 1, 2011

Enrollment Period

1.9 years

First QC Date

April 13, 2010

Last Update Submit

December 13, 2011

Conditions

Study Arms (1)

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

Interventions

no intervention, descriptive study

Surgery

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • years of age or above
  • ASA classification 1-4
  • undergoing fast-track hip or knee replacement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Lundbeck Centre for fast-track hip/knee surgery

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Lene Krenk, Doctor

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 15, 2010

Study Start

October 1, 2009

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

December 14, 2011

Record last verified: 2011-12

Locations