CognitionNCT01079468
Cognition in Postoperative Total Hip Arthroplasty and Total Hip Resurfacing Patients
An observational study of Cognition, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Transient cognitive changes after surgery may be due to many different factors. It is estimated that between 5-29% of patients undergoing orthopedic surgery experience a transient decline in their cognition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognition
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing either Total Hip Arthroplasty or Total Hip Resurfacing Arhtroplasty at our Institution
Who may be able to join
- Male and non-pregnant, non-lactating, female subjects who are 18 and older
- Subjects who are able and willing to provide informed consent
- Subjects deemed able to comply with study schedule visits and procedures
- Subjects undergoing elective THA procedures
- Subjects undergoing elective total hip resurfacing arthroplasty
- Subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination.
Who cannot join
- Subjects with or with a history of Parkinson's Disease
- Subjects with a history of depression as reported in their past medical history
- Subjects with a history of dementia as reported in their past medical history
- Subjects currently using antidepressants
- Subjects currently using antipsychotic medications
Trial locations and contacts
1 site in 1 country.
About this study
Transient cognitive changes after surgery may be due to many different factors. It is estimated that between 5-29% of patients undergoing orthopedic surgery experience a transient decline in their cognition. Fat and bone marrow debris embolization can cause cognitive changes if they enter the cerebral circulation in significant numbers. During total hip arthroplasty the placement of the femoral stem leads to a rise in intramedullary pressure which can cause fat and bone marrow debris to embolize into the systemic circulation. Total hip resurfacing arthroplasty avoids entrance into the femoral canal. The purpose of this study is to assess transient cognitive changes after total hip arthroplasty and compare them to patients undergoing total hip resurfacing arthroplasty. We hypothesize that patients undergoing total hip resurfacing arthroplasty will experience less transient cognitive changes due to the avoidance of violating the femoral canal during the procedure.
- Conditions
- Cognition
- Keywords
- Transient cognitive decline following orthopaedic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total Hip Arthroplasty | Not described | |
| Total Hip Resurfacing Arthroplasty | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of transient cognitive changes postoperatively as measured by the Folstein mini-mental examination
Secondary outcomes (1)
Percentage of patient who experience transient cognitive decline following Total Hip Arthroplasty or total hip resurfacing arthroplasty as measured by the Folstein mini-mental examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079468
- Sponsor's protocol ID
- RIUHOZ 10-01
- Status last verified
- Nov 2011
- First submitted
- 1 Mar 2010
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Koch S, Forteza A, Lavernia C, Romano JG, Campo-Bustillo I, Campo N, Gold S. Cerebral fat microembolism and cognitive decline after hip and knee replacement. Stroke. 2007 Mar;38(3):1079-81. doi: 10.1161/01.STR.0000258104.01627.50. Epub 2007 Jan 25.
PubMed 17255544Koessler MJ, Pitto RP. Fat embolism and cerebral function in total hip arthroplasty. Int Orthop. 2002;26(5):259-62. doi: 10.1007/s00264-002-0380-2. Epub 2002 Jun 25. No abstract available.
PubMed 12378348
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition in Postoperative Total Hip Arthroplasty and Total Hip Resurfacing Patients
- ClinicalTrials.gov ID
- NCT01079468
- Acronym / sponsor ID
- RIUHOZ 10-01
- Conditions
- Cognition
- Keywords
- Transient cognitive decline following orthopaedic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Mar 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.
Transient cognitive changes after surgery may be due to many different factors. It is estimated that between 5-29% of patients undergoing orthopedic surgery experience a transient decline in their cognition. Fat and bone marrow debris embolization can cause cognitive changes if they enter the cerebral circulation in significant numbers. During total hip arthroplasty the placement of the femoral stem leads to a rise in intramedullary pressure which can cause fat and bone marrow debris to embolize into the systemic circulation. Total hip resurfacing arthroplasty avoids entrance into the femoral canal. The purpose of this study is to assess transient cognitive changes after total hip arthroplasty and compare them to patients undergoing total hip resurfacing arthroplasty. We hypothesize that patients undergoing total hip resurfacing arthroplasty will experience less transient cognitive changes due to the avoidance of violating the femoral canal during the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Hip Arthroplasty | – | – |
| Total Hip Resurfacing Arthroplasty | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing either Total Hip Arthroplasty or Total Hip Resurfacing Arhtroplasty at our Institution
Key inclusion criteria (6 listed)
- Male and non-pregnant, non-lactating, female subjects who are 18 and older
- Subjects who are able and willing to provide informed consent
- Subjects deemed able to comply with study schedule visits and procedures
- Subjects undergoing elective THA procedures
- Subjects undergoing elective total hip resurfacing arthroplasty
Key exclusion criteria (5 listed)
- Subjects with or with a history of Parkinson's Disease
- Subjects with a history of depression as reported in their past medical history
- Subjects with a history of dementia as reported in their past medical history
- Subjects currently using antidepressants
- Subjects currently using antipsychotic medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Degree of transient cognitive changes postoperatively as measured by the Folstein mini-mental examination
1 secondary outcome
Percentage of patient who experience transient cognitive decline following Total Hip Arthroplasty or total hip resurfacing arthroplasty as measured by the Folstein mini-mental examination
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 8 Nov 2011.
- Background: PubMed 17255544Koch S, Forteza A, Lavernia C, Romano JG, Campo-Bustillo I, Campo N, Gold S. Cerebral fat microembolism and cognitive decline after hip and knee replacement. Stroke. 2007 Mar;38(3):1079-81. doi: 10.1161/01.STR.0000258104.01627.50. Epub 2007 Jan 25.
- Background: PubMed 12378348Koessler MJ, Pitto RP. Fat embolism and cerebral function in total hip arthroplasty. Int Orthop. 2002;26(5):259-62. doi: 10.1007/s00264-002-0380-2. Epub 2002 Jun 25. No abstract available.
Related trials for Cognition
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cognition, run by Rothman Institute Orthopaedics at 1 site in United States.
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 6 inclusion and 5 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 8 Nov 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 United States. 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.
What does the primary outcome measure?
Degree of transient cognitive changes postoperatively as measured by the Folstein mini-mental examination. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01079468, which also lists 2 linked publications.
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 8 Nov 2011.