Postoperative Cognitive DysfunctionNCT01103752
Postoperative Cognitive Dysfunction After Total Knee or Hip Replacement Surgery in Fast-track Set-up
An observational study of Postoperative Cognitive Dysfunction, run by Lene Krenk at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- How many people
- 225 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients undergoing fast-track knee or hip replacement surgery at one of the hospitals participating (Hidovre, Holstebro, Hørsholm, Århus)
Who may be able to join
- 60 years of age or above
- ASA classification 1-4
- undergoing fast-track hip or knee replacement
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- no intervention, descriptive study
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, descriptive studyOther
no intervention, descriptive study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: no intervention, descriptive study |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lene Krenk
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Sponsor-investigator, Lene Krenk, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lene Krenk, Doctor, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103752
- Sponsor's protocol ID
- H-3-2009-096
- Status last verified
- Dec 2011
- First submitted
- 13 Apr 2010
- Last updated
- 14 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Cognitive Dysfunction After Total Knee or Hip Replacement Surgery in Fast-track Set-up
- ClinicalTrials.gov ID
- NCT01103752
- Acronym / sponsor ID
- H-3-2009-096
- Conditions
- Postoperative Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Lene KrenkUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Other: no intervention, descriptive studyThis 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing fast-track knee or hip replacement surgery at one of the hospitals participating (Hidovre, Holstebro, Hørsholm, Århus)
Key inclusion criteria (3 listed)
- 60 years of age or above
- ASA classification 1-4
- undergoing fast-track hip or knee replacement
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention, descriptive studyno intervention, descriptive study | Other | Surgery |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene Krenk, Doctor principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction, run by Lene Krenk at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2011.