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Cognition Following Computer Assisted Total Knee Arthroplasty (Minimental)

This study has been completed.
Sponsor:
Information provided by:
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT00830986
First received: January 26, 2009
Last updated: April 14, 2009
Last verified: January 2009
History of Changes

January 26, 2009
April 14, 2009
July 2005
March 2006   (final data collection date for primary outcome measure)
Folstein Mini Mental State Examination (MMSE) [ Time Frame: 6 Months Post-Operative ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00830986 on ClinicalTrials.gov Archive Site
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Cognition Following Computer Assisted Total Knee Arthroplasty
Cognition Following Computer Assisted Total Knee Arthroplasty: A Prospective Cohort Study

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.

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
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

100 Consecutive patients requiring a total knee arthroplasty for degenerative arthritis of the knee
  • Cognition
  • Embolism, Fat
  • Device: Total Knee Arthroplasty Implant (Scorpio®)
    Implantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation
    Other Name: Scorpio Total Knee Arthroplasty
  • Device: Total Knee Arthroplasty Implant (Scorpio®)
    Implantation of a Total Knee Arthroplasty using a Computer Assisted Software, without Intramedullary Instrumentation
    Other Name: Scorpio Total Knee Arthroplasty
  • 1
    Computer Assisted Total Knee Arthroplasty
    Intervention: Device: Total Knee Arthroplasty Implant (Scorpio®)
  • 2
    Conventional Instrumented Total Knee Arthroplasty
    Intervention: Device: Total Knee Arthroplasty Implant (Scorpio®)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2006
March 2006   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00830986
RIUWHOZ 09-01
No
Javad Parvizi, Rothman Institute of Orthopaedics
Rothman Institute Orthopaedics
Not Provided
Principal Investigator: Javad Parvizi, MD, FRCS Rothman Institute of Orthopaedics
Rothman Institute Orthopaedics
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP