Cognition Following Computer Assisted Total Knee Arthroplasty (Minimental)

Tracking Information
First Submitted Date	January 26, 2009
First Posted Date	January 28, 2009
Last Update Posted Date	April 16, 2009
Study Start Date	July 2005
Actual Primary Completion Date	March 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: January 26, 2009)	Folstein Mini Mental State Examination (MMSE) [ Time Frame: 6 Months Post-Operative ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT00830986 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Cognition Following Computer Assisted Total Knee Arthroplasty
Official Title	Cognition Following Computer Assisted Total Knee Arthroplasty: A Prospective Cohort Study
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.
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
Study Design	Observational Model: Case Control; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	100 Consecutive patients requiring a total knee arthroplasty for degenerative arthritis of the knee
Condition	Cognition; Embolism, Fat
Intervention	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
Study Groups/Cohorts	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®)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: January 26, 2009)	100
Original Actual Enrollment	Same as current
Actual Study Completion Date	March 2006
Actual Primary Completion Date	March 2006 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Not Provided
Removed Location Countries
Administrative Information
NCT Number	NCT00830986
Other Study ID Numbers	RIUWHOZ 09-01
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Javad Parvizi, Rothman Institute of Orthopaedics
Study Sponsor	Rothman Institute Orthopaedics
Collaborators	Not Provided
Investigators	Principal Investigator: Javad Parvizi, MD, FRCS Rothman Institute of Orthopaedics
PRS Account	Rothman Institute Orthopaedics
Verification Date	January 2009