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Completed

NCT Number: NCT00830986

Cognition Following Computer Assisted Total Knee Arthroplasty

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.

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Key information

Conditions

Cognition Cardiovascular Diseases Embolism Embolism and Thrombosis Embolism, Fat Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Knee Arthroplasty Implant (Scorpio®)

Device

Implantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation

Other names: Scorpio Total Knee Arthroplasty

Primary outcomes

  1. Folstein Mini Mental State Examination (MMSE)

    Time frame: 6 Months Post-Operative

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Official study title

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

Acronym: Minimental

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 28, 2009
Registry last updated
Apr 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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