Postoperative Cognitive Dysfunction After Total Knee or H... | NCT01103752

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

NCT01103752

Sponsor

Lene Krenk

Status

Completed

Last Update Posted

Dec 14, 2011Estimated

Enrollment

225Actual

Phase

Not provided

Conditions

Postoperative Cognitive Dysfunction

Interventions

no intervention, descriptive study

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Apr 13, 2010

First Submission Date that Met QC Criteria

Apr 13, 2010

First Posted Date

Apr 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2011

Last Update Posted Date

Dec 14, 2011Estimated

Name	Class
Lundbeck Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

225Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
no intervention, descriptive study	Other	no intervention, descriptive study	Surgery

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lene Krenk, Doctor	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Lundbeck Centre for fast-track hip/knee surgery		Copenhagen			Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000079690	Postoperative Cognitive Complications

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D060825	Cognitive Dysfunction

Browse Leaves

Not provided

Browse Branches

Not provided