Trials / Completed
CompletedNCT00830986
Cognition Following Computer Assisted Total Knee Arthroplasty
Cognition Following Computer Assisted Total Knee Arthroplasty: A Prospective Cohort Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Rothman Institute Orthopaedics · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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. 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Total Knee Arthroplasty Implant (Scorpio®) | Implantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation |
| DEVICE | Total Knee Arthroplasty Implant (Scorpio®) | Implantation of a Total Knee Arthroplasty using a Computer Assisted Software, without Intramedullary Instrumentation |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2006-03-01
- Completion
- 2006-03-01
- First posted
- 2009-01-28
- Last updated
- 2009-04-16
Source: ClinicalTrials.gov record NCT00830986. Inclusion in this directory is not an endorsement.