Cognitive Changes After Major Joint Replacement

Mild Cognitive Impairment Clinical Trial

— Cognigram  

Official title:

Assessing Postoperative Cognitive Changes After Major Joint Arthroplasty: A Feasibility Study Using the CogState Brief Battery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964221
• Other study ID #: 045-2015
• Status: Completed
• Phase: N/A
• First received: November 1, 2016
• Last updated: May 8, 2017
• Start date: June 15, 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: May 2017
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients assume that cognitive performance rapidly returns to baseline after anesthesia and surgery. Several studies have shown that one week after major non-cardiac surgery about 27% of patients have postoperative cognitive dysfunction (POCD) and 10% of patients at 3 months. Very few studies have assessed the incidence of POCD beyond 3 months. POCD significantly reduces quality of life. Identifying risk factors for POCD is important because it is associated with prolonged hospital stay, loss of independence, and premature retirement. There is an urgent need to measure and document the level of cognitive change associated with surgery with an easy to use tool, both prior to admission and after discharge. This information can be used to plan appropriate care paths and to identify or test the efficacy of potential new treatments to alter the negative trajectory.

Description:

Postoperative cognitive dysfunction (POCD) is thought to affect a significant proportion of patients after major surgery (up to 10% at 3 months). This is potentially a major public health issue because patients with POCD have prolonged hospital admission, loss of independence and mortality. Undoubtedly, if POCD is as prevalent and devastating as has been previously reported, the decision to undergo elective surgery should be influenced by the risk of developing POCD. Given the scope of the issue, the deficiencies in the literature surrounding POCD are concerning. There are many methodological issues with previous studies and the diagnosis of POCD in the perioperative period.

It is imperative that the true natures of postoperative cognitive changes are elucidated so that preoperative risk stratification can be appropriately determined. This will lead to care pathways and interventions that can modify any possible downward changes thereby reducing the negative impact on patients and the health care system.

Study Hypothesis: The incidence of postoperative cognitive changes in the joint arthroplasty population is influenced by postoperative complications, pre-existing mild cognitive impairment, and pre-existing comorbid conditions.

Study Objectives:

1. To conduct a pilot study for six to 12 months to assess both the rate of recruitment (goal of 15 participants/month) and postoperative in-person follow-up (at 6 weeks and 4.5 months), and determine if a large-scale study of 600 participants is feasible

2. To determine the sensitivity and accuracy of Cognigram (CogState Brief Battery - CBB) for detecting changes in cognitive function during the perioperative period

3. To determine whether pre-existing mild cognitive impairment (MCI), preoperative chronic inflammatory states, and acute postoperative complications affect changes in postoperative cognitive function

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• All patients = 50 years of age undergoing elective total hip or knee arthroplasty at Sunnybrook Health Sciences Centre

Exclusion Criteria:

• Lack of informed consent

• Inability to comply with study procedures or follow-up visits

• Patients with diagnosed dementia or those being treated with donepezil (Aricept®)

• Patients with severe cognitive impairment defined as baseline with a CBB score of equal to or less than 80 in at least one of the 4 CBB domains

• Patients with psychiatric diagnoses including schizophrenia, bipolar disorder, major depressive mood disorder

• Patients undergoing a second joint replacement & previously enrolled in this study within the past 6 months

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Change
• Cognitive Deficit
• Delirium
• Mild Cognitive Impairment
• Postoperative Cognitive Dysfunction
• Working Memory

Intervention

Other:
• Cognitive Testing
Computerized CogState Brief Battery (CBB), Cognigram, assesses changes in four cognitive domains including psychomotor function, attention, learning and memory, and working memory. The CBB is a computerized test based on card games that can be administered online. .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Stephen Choi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery	Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery	4.5 months after surgery
Secondary	Proportion of patients developing severe cognitive dysfunction at 4.5 months after surgery (defined as CBB score less than 80)	Proportion of patients developing severe cognitive dysfunction at 4.5 months after surgery (defined as CBB score less than 80)	4.5 months after surgery
Secondary	Proportion of patients developing mild cognitive impairment at 4.5 months after surgery defined as CBB score between 81 and 90	Proportion of patients developing mild cognitive impairment at 4.5 months after surgery defined as CBB score between 81 and 90	4.5 months after surgery
Secondary	The effect of pre-operative mild cognitive impairment, pre-operative chronic inflammatory states, postoperative delirium, and postoperative complications on the incidence of mild cognitive impairment and severe cognitive dysfunction at 4.5 months	The effect of pre-operative mild cognitive impairment, pre-operative chronic inflammatory states, postoperative delirium, and postoperative complications on the incidence of mild cognitive impairment and severe cognitive dysfunction at 4.5 months	4.5 months after surgery