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

NCT04267328 | Completed Results

• 1 other identifier: A19-224
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients having surgery

Older adults undergoing elective orthopedic surgery.

Procedure: Elective Orthopedic Surgery

Interventions

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.

Patients having surgery

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

Results Point of Contact

• Title: Clinical Research Coodinator
• Organization: HealthPartners Institute - Neuroscience

clincialtrials@HealthPartners.com

651-495-6360

Study Officials

• Michael H Rosenbloom, MD

  HealthPartners Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 12, 2020
• Study Start: January 6, 2020
• Primary Completion: May 9, 2023
• Study Completion: June 14, 2023
• Last Updated: April 19, 2024
• Results First Posted: April 19, 2024

Record last verified: 2022-09

Locations

US (1)