Cognition Following Computer Assisted Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-03-31

Brief Summary

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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.

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Detailed Description

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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

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Cognition Embolism, Fat

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Computer Assisted Total Knee Arthroplasty

Total Knee Arthroplasty Implant (Scorpio®)

Intervention Type DEVICE

Implantation of a Total Knee Arthroplasty using a Computer Assisted Software, without Intramedullary Instrumentation

2

Conventional Instrumented Total Knee Arthroplasty

Total Knee Arthroplasty Implant (Scorpio®)

Intervention Type DEVICE

Implantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation

Interventions

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Total Knee Arthroplasty Implant (Scorpio®)

Implantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation

Intervention Type DEVICE

Total Knee Arthroplasty Implant (Scorpio®)

Implantation of a Total Knee Arthroplasty using a Computer Assisted Software, without Intramedullary Instrumentation

Intervention Type DEVICE

Other Intervention Names

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Scorpio Total Knee Arthroplasty Scorpio Total Knee Arthroplasty

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No