Cognition Following Computer Assisted Total Knee Arthroplasty

Cognition Clinical Trial

— Minimental  

Official title:

Cognition Following Computer Assisted Total Knee Arthroplasty: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830986
• Other study ID #: RIUWHOZ 09-01
• 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

• Cognition
• Embolism
• Embolism, Fat

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