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
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Sponsor:
Rothman Institute Orthopaedics
Information provided by:
Rothman Institute Orthopaedics
Tracking Information | ||||
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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 |
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
Exclusion criteria
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Study Type | Observational | |||
Study Design | Observational Model: Case Control Time Perspective: Prospective |
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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 |
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Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Rothman Institute Orthopaedics | |||
Verification Date | January 2009 |