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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
  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:

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

Further study details as provided by Rothman Institute Orthopaedics:

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

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830986

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

No publications provided

Responsible Party: Javad Parvizi, Rothman Institute of Orthopaedics
ClinicalTrials.gov Identifier: NCT00830986     History of Changes
Other Study ID Numbers: RIUWHOZ 09-01
Study First Received: January 26, 2009
Last Updated: April 14, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 18, 2012