Clinical Trials Directory

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

TypeNameDescription
DEVICETotal Knee Arthroplasty Implant (Scorpio®)Implantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation
DEVICETotal 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.