Completed

NCT Number: NCT02964221

Cognitive Changes After Major Joint Replacement

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.

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Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Change Cognitive Deficit Cognitive Dysfunction Confusion Delirium Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications Signs and Symptoms Working Memory

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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:

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
To determine the sensitivity and accuracy of Cognigram (CogState Brief Battery - CBB) for detecting changes in cognitive function during the perioperative period
To determine whether pre-existing mild cognitive impairment (MCI), preoperative chronic inflammatory states, and acute postoperative complications affect changes in postoperative cognitive function

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive testing

Other

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. .

Primary outcomes

Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery

Time frame: 4.5 months after surgery

Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery

Secondary outcomes

Proportion of patients developing severe cognitive dysfunction at 4.5 months after surgery (defined as CBB score less than 80)

Time frame: 4.5 months after surgery

Proportion of patients developing severe cognitive dysfunction at 4.5 months after surgery (defined as CBB score less than 80)
Proportion of patients developing mild cognitive impairment at 4.5 months after surgery defined as CBB score between 81 and 90

Time frame: 4.5 months after surgery

Proportion of patients developing mild cognitive impairment at 4.5 months after surgery defined as CBB score between 81 and 90
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

Time frame: 4.5 months after surgery

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

Sponsors and collaborators

Lead sponsor

Dr. Stephen Choi

Other

Registry information

Official study title

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

Acronym: Cognigram

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Nov 16, 2016
Registry last updated: May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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