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Post-Operative Cognitive Dysfunction in Normal Aging Patients Undergoing Elective Orthopedic Surgery

Post-Operative Cognitive Dysfunction in Normal Aging Patients Undergoing Elective Orthopedic Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04267328
Acronym
POCD
Enrollment
47
Registered
2020-02-12
Start date
2020-01-06
Completion date
2023-06-14
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Cognitive Dysfunction

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

HealthPartners Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Presence of Post Operative Cognitive Dysfunction (POCD)3 monthsDefined 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

ArmCount
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
Total47

Baseline characteristics

CharacteristicPatients Having Surgery
Age, Continuous69 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 typeEG000
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

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients Having SurgeryPresence of Post Operative Cognitive Dysfunction (POCD)15 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026