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

NCT ID: NCT04267328

Last Updated: 2024-04-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-06

Study Completion Date

2023-06-14

Brief Summary

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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.

Detailed Description

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Conditions

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Post Operative Cognitive Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients having surgery

Older adults undergoing elective orthopedic surgery.

Elective Orthopedic Surgery

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael H Rosenbloom, MD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Neurology

Locations

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HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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A19-224

Identifier Type: -

Identifier Source: org_study_id

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