Cognitive Changes After Major Joint Replacement (Cognigram)
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|ClinicalTrials.gov Identifier: NCT02964221|
Recruitment Status : Completed
First Posted : November 16, 2016
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment|
|Postoperative Cognitive Dysfunction Mild Cognitive Impairment Delirium Cognitive Deficit Cognitive Change Working Memory||Other: Cognitive Testing|
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.
- 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
|Study Type :||Observational|
|Actual Enrollment :||90 participants|
|Official Title:||Assessing Postoperative Cognitive Changes After Major Joint Arthroplasty: A Feasibility Study Using the CogState Brief Battery|
|Actual Study Start Date :||June 15, 2016|
|Actual Primary Completion Date :||May 1, 2017|
|Actual Study Completion Date :||May 1, 2017|
- 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. .
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964221
|Principal Investigator:||Stephen Choi, MD,FRCPC,MSc||Sunnybrook Health Sciences Centre|