Cognition Following Computer Assisted Total Knee Arthroplasty - Full Text View

Sponsor:	Rothman Institute Orthopaedics
Information provided by:	Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:	NCT00830986

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:	Case Control, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
2 Conventional Instrumented Total Knee Arthroplasty	Device: Total Knee Arthroplasty Implant (Scorpio®) Implantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation

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:	Rothman Institute of Orthopaedics ( Javad Parvizi )
Study ID Numbers:	RIUWHOZ 09-01
Study First Received:	January 26, 2009
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00830986 History of Changes
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 and Thrombosis
Embolism
Vascular Diseases
Embolism, Fat
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010