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Trial Outcomes & Findings for Post-Operative Cognitive Dysfunction in Normal Aging Patients Undergoing Elective Orthopedic Surgery (NCT NCT04267328)

NCT ID: NCT04267328

Last Updated: 2024-04-19

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

47 participants

Primary outcome timeframe

3 months

Results posted on

2024-04-19

Participant Flow

Participant milestones

Participant milestones
Measure
Patients Having Surgery
Older adults undergoing elective orthopedic surgery. 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.
Overall Study
STARTED
47
Overall Study
COMPLETED
47
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Patients Having Surgery
n=47 Participants
Older adults undergoing elective orthopedic surgery. 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.
Age, Continuous
69 years
STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male
Female
32 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
46 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
47 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
47 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Patients Having Surgery
n=47 Participants
Older adults undergoing elective orthopedic surgery. 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.
Presence of Post Operative Cognitive Dysfunction (POCD)
15 Participants

Adverse Events

Patients Having Surgery

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Coodinator

HealthPartners Institute - Neuroscience

Phone: 651-495-6360

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place