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Cognition Following Computer Assisted Total Knee Arthroplasty (Minimental)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00830986
First Posted: January 28, 2009
Last Update Posted: April 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rothman Institute Orthopaedics
  Purpose
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 Intervention
Cognition Embolism, Fat Device: Total Knee Arthroplasty Implant (Scorpio®)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cognition Following Computer Assisted Total Knee Arthroplasty: A Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by Rothman Institute Orthopaedics:

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

Enrollment: 100
Study Start Date: July 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility

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
  Contacts and Locations
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
  More Information

Responsible Party: Javad Parvizi, Rothman Institute of Orthopaedics
ClinicalTrials.gov Identifier: NCT00830986     History of Changes
Other Study ID Numbers: RIUWHOZ 09-01
First Submitted: January 26, 2009
First Posted: January 28, 2009
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