An observational study in Post-Operative Cognitive Decline in Older Adults, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-08.
Sponsored by University of Florida · Observational
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.
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 147 is close to the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Two age-matched participant groups will be recruited. Healthy non-demented age matched patients undergoing elective total knee arthoplasty, and age, education, and diseased matched (osteoarthritis knee pain;) non-surgery peers.
Exclusion Criteria:
Underlying medical diseases likely to limit lifespan or confound outcome analyses:
Neurodegenerative Exclusions:
Psychiatric Exclusions:
Conditions or behaviors likely to affect imaging or cognitive testing:
80 patients will undergo total knee replacement surgery; two Magnetic Resonance Imaging scans; cognitive assessment testing.
Other: Magnetic Resonance Imaging · Behavioral: Cognitive assessment testing
80 non-surgery participants will be included as part of the control group; two Magnetic Resonance Imaging scans; cognitive assessment testing.
Other: Magnetic Resonance Imaging · Behavioral: Cognitive assessment testing
Both groups will undergo two MRIs at baseline and within 48 hours after surgery/non-surgery.
Also known as: MRI
Both groups will undergo in-person baseline assessment of cognitive functioning as well as assessments at three weeks, three months and one year.
Also known as: Cognitive assessement tests
Predicting Executive Decline
Severity of pre-surgical/baseline neuroimaging markers of cerebrovascular disease will predict post-operative executive decline at 3 weeks, 3 months and 1 year.
Time frame: baseline, 3 weeks, 3 months, 1 year
Predicting Memory Decline
Pre-surgical/baseline neuroimaging markers of entorhinal-hippocampal white matter connectivity will predict post-operative memory decline at 3 weeks, 3 months and 1 year.
Time frame: baseline, 3 weeks, 3 months, 1 year
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University of Florida