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

Post Operative Cognitive Dysfunction Clinical Trial

— POCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04267328
• Other study ID #: A19-224
• Status: Completed
• Start date: January 6, 2020
• Est. completion date: June 14, 2023

Study information

• Verified date: September 2022
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 14, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Post Operative Cognitive Dysfunction
• Postoperative Cognitive Complications

Intervention

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.

Locations

Country	Name	City	State
United States	HealthPartners Neuroscience Center	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 months