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

August 21, 2023 updated by: HealthPartners Institute
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55130
        • HealthPartners Neuroscience Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to Regions Hospital orthopedics center in Saint Paul, MN with a scheduled surgery fitting the diagnostic codes listed in the eligibility criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients having surgery
Older adults undergoing elective orthopedic surgery.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of post operative cognitive dysfunction (POCD)
Time Frame: 3 months
Defined as a 1.5 standard deviation decline 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Investigators

  • Principal Investigator: Michael H Rosenbloom, MD, HealthPartners Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2020

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 11, 2020

First Posted (Actual)

February 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A19-224

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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