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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00830986
Other study ID # RIUWHOZ 09-01
Secondary ID
Status Completed
Phase N/A
First received January 26, 2009
Last updated April 14, 2009
Start date July 2005
Est. completion date March 2006

Study information

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

Clinical 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. 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.


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


Recruitment information / eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Total Knee Arthroplasty Implant (Scorpio®)
Implantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation
Total Knee Arthroplasty Implant (Scorpio®)
Implantation of a Total Knee Arthroplasty using a Computer Assisted Software, without Intramedullary Instrumentation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Outcome

Type Measure Description Time frame Safety issue
Primary Folstein Mini Mental State Examination (MMSE) 6 Months Post-Operative Yes
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