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

• Sponsor: HealthPartners Institute (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04267328
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 34.8
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Cognitive Dysfunction	Procedure: Elective Orthopedic Surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-Operative Cognitive Dysfunction in Normal Aging Patients Undergoing Elective Orthopedic Surgery
• Actual Study Start Date: Jan 6, 2020
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Presence of post operative cognitive dysfunction (POCD) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HealthPartners Neuroscience Center	Saint Paul	Minnesota	United States	55130

Sponsors and Collaborators

• HealthPartners Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HealthPartners Institute
• ClinicalTrials.gov Identifier: NCT04267328
• Other Study ID Numbers: A19-224
• First Posted: Feb 12, 2020
• Last Update Posted: Feb 22, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction

Study Results

No Results Posted as of Feb 22, 2022