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OpenTrials
Completed

NCT Number: NCT04267328

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

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.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elective Orthopedic Surgery

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.

Primary outcomes

  1. Presence of Post Operative Cognitive Dysfunction (POCD)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Acronym: POCD

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2020
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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