CognitionMinimentalNCT00830986
Cognition Following Computer Assisted Total Knee Arthroplasty
An observational study of Cognition and Embolism, Fat, run by Rothman Institute Orthopaedics.
Trial summary
A significant number of patients experience postoperative cognitive changes following total joint arthroplasty. Among other causes, the mental status change may be the result of fat and bone marrow debris embolization. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cognition, Embolism, Fat
- What is being tested?
- Total Knee Arthroplasty Implant (Scorpio®)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Mar 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 100 Consecutive patients requiring a total knee arthroplasty for degenerative arthritis of the knee
Who may be able to join
- Primary, cemented knee arthroplasty
- Unilateral or bilateral TKA
Who cannot join
- Patient is unable to speak English
- Unable to read and write
- Patient with history of psychiatric disorders (Depression, Schizophrenia, anxiety, bipolar dis.)
- Patients with history of IV drug abuse
- Previous history of dementia
- Patients on mental status changing medications
About this study
Official title: Cognition Following Computer Assisted Total Knee Arthroplasty: A Prospective Cohort Study
A significant number of patients experience postoperative cognitive changes following total joint arthroplasty. Among other causes, the mental status change may be the result of fat and bone marrow debris embolization. We hypothesized that the use of computer assisted total knee arthroplasty, which does not utilize intramedullary alignment rods, would produce less fat and bone marrow debris embolization and, hence, fewer mental status changes.
Read the detailed description
Inclusion criteria
- Primary, cemented knee arthroplasty
- Unilateral or bilateral TKA
Exclusion criteria
- Patient is unable to speak English
- Unable to read and write
- Patient with history of psychiatric disorders (Depression, Schizophrenia, anxiety, bipolar dis.)
- Patients with history of IV drug abuse
- Previous history of dementia
- Patients on mental status changing medications
- Conditions
- Cognition, Embolism, Fat
- Being tested
- Total Knee Arthroplasty Implant (Scorpio®)
- Keywords
- Mental Cognition Change, Fat Embolism, Bone Marrow Debris Emboli, Computer Assisted Total Knee Arthroplasty, Conventional Instrumented Total Knee Arthroplasty
- Medical subject headings
- Embolism, Fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Arthroplasty Implant (Scorpio®)Device
Also called Scorpio Total Knee Arthroplasty
Implantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation
Total Knee Arthroplasty Implant (Scorpio®)Device
Also called Scorpio Total Knee Arthroplasty
Implantation of a Total Knee Arthroplasty using a Computer Assisted Software, without Intramedullary Instrumentation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Computer Assisted Total Knee Arthroplasty Receives: Device: Total Knee Arthroplasty Implant (Scorpio®) | |
| 2 | Conventional Instrumented Total Knee Arthroplasty Receives: Device: Total Knee Arthroplasty Implant (Scorpio®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Folstein Mini Mental State Examination (MMSE)
Measured: 6 Months Post-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJul 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Investigators
- Javad Parvizi, MD, FRCS, Principal investigator, Rothman Institute of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830986
- Sponsor's protocol ID
- RIUWHOZ 09-01
- Acronym
- Minimental
- Status last verified
- Jan 2009
- First submitted
- 26 Jan 2009
- Last updated
- 16 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition Following Computer Assisted Total Knee Arthroplasty: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT00830986
- Acronym / sponsor ID
- Minimental / RIUWHOZ 09-01
- Conditions
- Cognition, Embolism, Fat
- Keywords
- Mental Cognition Change, Fat Embolism, Bone Marrow Debris Emboli, Computer Assisted Total Knee Arthroplasty, Conventional Instrumented Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 28 Jan 2009 (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.
A significant number of patients experience postoperative cognitive changes following total joint arthroplasty. Among other causes, the mental status change may be the result of fat and bone marrow debris embolization. We hypothesized that the use of computer assisted total knee arthroplasty, which does not utilize intramedullary alignment rods, would produce less fat and bone marrow debris embolization and, hence, fewer mental status changes.
Detailed description
Inclusion criteria
- Primary, cemented knee arthroplasty
- Unilateral or bilateral TKA
Exclusion criteria
- Patient is unable to speak English
- Unable to read and write
- Patient with history of psychiatric disorders (Depression, Schizophrenia, anxiety, bipolar dis.)
- Patients with history of IV drug abuse
- Previous history of dementia
- Patients on mental status changing medications
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Total Knee Arthroplasty Implant (Scorpio®)Computer Assisted Total Knee Arthroplasty |
| 2 | – | Device: Total Knee Arthroplasty Implant (Scorpio®)Conventional Instrumented Total Knee Arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 100 Consecutive patients requiring a total knee arthroplasty for degenerative arthritis of the knee
Key inclusion criteria (2 listed)
- Primary, cemented knee arthroplasty
- Unilateral or bilateral TKA
Key exclusion criteria (6 listed)
- Patient is unable to speak English
- Unable to read and write
- Patient with history of psychiatric disorders (Depression, Schizophrenia, anxiety, bipolar dis.)
- Patients with history of IV drug abuse
- Previous history of dementia
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 |
|---|---|---|
| Total Knee Arthroplasty Implant (Scorpio®)Also: Scorpio Total Knee ArthroplastyImplantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation | Device | 2 |
| Total Knee Arthroplasty Implant (Scorpio®)Also: Scorpio Total Knee ArthroplastyImplantation of a Total Knee Arthroplasty using a Computer Assisted Software, without Intramedullary Instrumentation | Device | 1 |
Primary outcome
Folstein Mini Mental State Examination (MMSE)
Time frame: 6 Months Post-Operative
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 16 Apr 2009.
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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.
Javad Parvizi, MD, FRCS principal investigator
Rothman Institute of Orthopaedics
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition and Embolism, Fat, run by Rothman Institute Orthopaedics.
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 2 inclusion and 6 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 16 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Folstein Mini Mental State Examination (MMSE) (time frame: 6 Months Post-Operative). It is what the study was designed to measure, not a finding.
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 16 Apr 2009; AzTrials last refreshed its copy on 31 Oct 2026.