Post Operative Cognitive Dysfunction
Conditions
Brief summary
Post-operative cognitive dysfunction (POCD) is a common concern for aging patients undergoing elective orthopedic surgery and significantly effects health outcomes. This study aims to evaluate the incidence of and risk factors associated with post-operative cognitive dysfunction in aging patients without prior history for mild cognitive impairment or dementia.
Interventions
Patients having knee (unilateral primary osteoarthritis or bilateral primary osteoarthritis) surgery, hip (unilateral primary osteoarthritis or bilateral primary osteoarthritis) or shoulder (primary osteoarthritis) elective surgery.
Sponsors
Study design
Eligibility
Inclusion criteria
* Age ≥50 and ≤90 * Any patient undergoing elective orthopedic surgery for hip, knee, or shoulder replacement (as defined by diagnostic codes: M16.0, M16.12, M16.11, M17.0, M17.12, M17.11, M19.011, M19.012)
Exclusion criteria
* History of cognitive impairment of dementia * Montreal cognitive assessment (MoCA) \<26 * History of Parkinson's disease, progressive supranuclear palsy, corticobasal degeneration, normal pressure hydrocephalus, Huntington's disease, stroke, seizure disorder, brain tumor, or brain surgery * History of surgery requiring anesthesia within the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Post Operative Cognitive Dysfunction (POCD) | 3 months | Defined as a decline of 1.5 or greater standard deviation on any one of the cognitive test performed from baseline to three-months post surgery. Score range: 0-100. A higher score indicates more cases of incident of POCD. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Having Surgery Older adults undergoing elective orthopedic surgery.
Elective Orthopedic Surgery: Patients having knee (unilateral primary osteoarthritis or bilateral primary osteoarthritis) surgery, hip (unilateral primary osteoarthritis or bilateral primary osteoarthritis) or shoulder (primary osteoarthritis) elective surgery. | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Patients Having Surgery |
|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Region of Enrollment United States | 47 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Presence of Post Operative Cognitive Dysfunction (POCD)
Defined as a decline of 1.5 or greater standard deviation on any one of the cognitive test performed from baseline to three-months post surgery. Score range: 0-100. A higher score indicates more cases of incident of POCD.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Having Surgery | Presence of Post Operative Cognitive Dysfunction (POCD) | 15 Participants |