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Cognition Following Computer Assisted Total Knee Arthroplasty (Minimental)

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ClinicalTrials.gov Identifier: NCT00830986
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : April 16, 2009
Sponsor:
Information provided by:
Rothman Institute Orthopaedics

Brief 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.

Condition or disease Intervention/treatment
Cognition Embolism, Fat Device: Total Knee Arthroplasty Implant (Scorpio®)

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

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cognition Following Computer Assisted Total Knee Arthroplasty: A Prospective Cohort Study
Study Start Date : July 2005
Primary Completion Date : March 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Group/Cohort Intervention/treatment
1
Computer Assisted 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
2
Conventional Instrumented Total Knee Arthroplasty
Device: Total Knee Arthroplasty Implant (Scorpio®)
Implantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation
Other Name: Scorpio Total Knee Arthroplasty



Primary Outcome Measures :
  1. Folstein Mini Mental State Examination (MMSE) [ Time Frame: 6 Months Post-Operative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100 Consecutive patients requiring a total knee arthroplasty for degenerative arthritis of the knee
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830986


Sponsors and Collaborators
Rothman Institute Orthopaedics
Investigators
Principal Investigator: Javad Parvizi, MD, FRCS Rothman Institute of Orthopaedics

Responsible Party: Javad Parvizi, Rothman Institute of Orthopaedics
ClinicalTrials.gov Identifier: NCT00830986     History of Changes
Other Study ID Numbers: RIUWHOZ 09-01
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: April 16, 2009
Last Verified: January 2009

Keywords provided by Rothman Institute Orthopaedics:
Mental Cognition Change
Fat Embolism
Bone Marrow Debris Emboli
Computer Assisted Total Knee Arthroplasty
Conventional Instrumented Total Knee Arthroplasty

Additional relevant MeSH terms:
Embolism
Embolism, Fat
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases