Clinical trial NCT02964221: Cognitive Changes After Major Joint Replacement
Official title: Assessing Postoperative Cognitive Changes After Major Joint Arthroplasty: A Feasibility Study Using the CogState Brief Battery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Cognitive Dysfunction
Mild Cognitive Impairment
Delirium
Cognitive Deficit
Cognitive Change
Working Memory
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA) at the Holland Orthopedic and Arthritic Centre (HOAC) at Sunnybrook Health Sciences Centre (SHSC).

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery
timeFrame: 4.5 months after surgery
Secondary outcomes:
measure: Proportion of patients developing severe cognitive dysfunction at 4.5 months after surgery (defined as CBB score less than 80)
timeFrame: 4.5 months after surgery
measure: Proportion of patients developing mild cognitive impairment at 4.5 months after surgery defined as CBB score between 81 and 90
timeFrame: 4.5 months after surgery
measure: 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
timeFrame: 4.5 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Stephen Choi, MD,FRCPC,MSc
role: PRINCIPAL_INVESTIGATOR
References: