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Clinical Trials/NCT04267328
NCT04267328
Completed
N/A

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

HealthPartners Institute1 site in 1 country47 target enrollmentJanuary 6, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post Operative Cognitive Dysfunction
Sponsor
HealthPartners Institute
Enrollment
47
Locations
1
Primary Endpoint
Presence of Post Operative Cognitive Dysfunction (POCD)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 6, 2020
End Date
June 14, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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