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Clinical Trial Summary

The purpose of the study is to examine specific neuroimaging predictors of memory and executive decline in older adults at various stages after total knee replacement surgery.


Clinical Trial Description

Cognitive impairment after major cardiac or non-cardiac surgery occurs in a high rate for older adults. The results of previous studies indicate that certain neuro-imaging markers can determine which individuals pose a greater risk for memory and thinking changes after surgery. Based on a pilot study, there is evidence that pre-surgical neuroimaging biomarkers associate with memory and executive decline after a well controlled surgical procedure (total knee antroplasty). In this study, researchers will use brain imaging studies to determine which patients are most likely to be affected by cognitive changes after this type of surgery. The use of Magnetic Resonance Imaging (MRI) will help investigators identify brain biomarkers that are associated with cognitive problems, such as white matter abnormalities and changes to small blood vessels. Patients undergoing total knee replacement surgery, as well as a group of non-surgery participants of similar age, education and health status,will receive cognitive testing and MRI brain scans before and after surgery/non-surgery. Researchers will compare and monitor both groups up to one year after surgery/non-surgery.

Prior to enrollment, participants will be asked to review the informed consent and provide written consent to participate in the study. The enrollment phase will involve in-person baseline assessment of cognitive functioning within two weeks of the scheduled surgery/non-surgery in order to rule out exclusion criteria. Testing will be in cooperation with the University of Florida General Clinical Research Center. Post-baseline MRI will be conducted on all participants (surgery/control) within 48 hours of the surgery/pseudo-surgery date to identify acute stroke differences from baseline. Cognitive assessments will be conducted for each participant at three-weeks, three-months, and one-year after surgery.

The research is highly significant because it will be the first study to use in-vivo diffusion imaging methods to examine the contribution of specific presurgical neuroanatomical vulnerabilities on executive and memory cognitive decline after one of the most common orthopedic surgeries sought by older adults. Additionally, it will be the first study to examine how specific neuroimaging biomarkers interact negatively with specific peri-operative variables including emboli number during surgery, embolic changes to the brain, anesthesia depth, and cerebral oxygenation.

The findings of the study will improve pre-surgery screening procedures for older adults and assist with the development of peri-operative interventions that will prevent neurodegenerative disease acceleration. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01786577
Study type Observational
Source University of Florida
Contact
Status Completed
Phase
Start date March 19, 2013
Completion date July 21, 2018