Cognition Clinical Trial
— MinimentalOfficial title:
Cognition Following Computer Assisted Total Knee Arthroplasty: A Prospective Cohort Study
Verified date | January 2009 |
Source | Rothman Institute Orthopaedics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 2006 |
Est. primary completion date | March 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rothman Institute Orthopaedics |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Folstein Mini Mental State Examination (MMSE) | 6 Months Post-Operative | Yes |
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