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Cognitive Changes After Major Joint Replacement - Full Trial (Cognigram 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03147937
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Stephen Choi, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment
Postoperative Cognitive Dysfunction Cognitive Impairment Mild Cognitive Impairment Delirium Cognitive Decline Cognitive Change Working Memory Autoimmune Diseases Inflammation Other: Cognitive Testing

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.

Main Study Hypothesis: The incidence of postoperative cognitive changes in the joint arthroplasty population is influenced by:

  1. Occurrence of major acute postoperative complications (e.g., cardiac event, pulmonary embolus, renal failure, pneumonia, prosthetic joint infection)
  2. Pre-existing mild cognitive impairment (MCI)
  3. Post-operative delirium
  4. Pre-existing comorbid conditions with inflammatory states such as auto-immune disorders, coronary artery disease, obstructive sleep apnea, and auto-immune disorders

Study Objectives:

In patients undergoing primary total hip or knee arthroplasty the goals of this project are to:

  1. Establish cognitive trajectories after major lower extremity joint arthroplasty and the incidence of both post-operative delirium and POCD
  2. Test Main Study Hypothesis (see above)

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Study Type : Observational
Estimated Enrollment : 505 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Postoperative Cognitive Changes After Major Joint Arthroplasty: A Prospective Cohort Study
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : October 2021

Intervention Details:
  • 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


Primary Outcome Measures :
  1. Proportion of patients with Cognigram score decreasing by > 2 SDs from baseline at 4.5 [ Time Frame: 4.5 months from baseline ]
    Proportion of patients with Cognigram score decreasing by > 2 SDs from baseline at 4.5


Secondary Outcome Measures :
  1. Proportion of patients with Cognigram score decreasing between 1 and 2 standard deviations from baseline at 4.5 months [ Time Frame: 4.5 months from baseline ]
    Proportion of patients with Cognigram score decreasing between 1 and 2 standard deviations from baseline at 4.5 months

  2. Effect of pre-operative MCI on postoperative cognitive changes at 4.5 months [ Time Frame: 4.5 months from baseline ]
    Effect of pre-operative MCI on postoperative cognitive changes at 4.5 months

  3. Effect of pre-operative chronic inflammatory states on postoperative cognitive changes at 4.5 months [ Time Frame: 4.5 months from baseline ]
    Effect of pre-operative chronic inflammatory states on postoperative cognitive changes at 4.5 months

  4. Effect of postoperative delirium on postoperative cognitive changes at 4.5 months [ Time Frame: 4.5 months from baseline ]
    Effect of postoperative delirium on postoperative cognitive changes at 4.5 months

  5. Effect of postoperative complications on postoperative cognitive changes at 4.5 months [ Time Frame: 4.5 months from baseline ]
    Effect of postoperative complications on postoperative cognitive changes at 4.5 months



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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 uncontrolled 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

Information from the National Library of Medicine

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): NCT03147937


Contacts
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Contact: Stephen Choi, MD,FRCPC,MSc 416-480-6100 ext 4864 stephen.choi@sunnybrook.ca
Contact: Shelly Au, PhD, PMP 416-480-6100 ext 89607 shelly.au@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Lilia Kaustov, PhD    416-480-6100 ext 89607    lilia.kaustov@sunnybrook.ca   
Principal Investigator: Stephen Choi, MD,FRCPC,MSc         
Sub-Investigator: Sinziana Avramescu, MD,FRCPC,PhD         
Sub-Investigator: Beverley A. Orser, MD,FRCPC,PhD         
Sub-Investigator: Benjamin Goldstein, MD,FRCPC,PhD         
Sub-Investigator: Damon Scales, MD,FRCPC,PhD         
Sub-Investigator: Mario Masellis, MD,FRCPC,PhD         
Sub-Investigator: Sara Mitchell, MD         
Sub-Investigator: Kevin Thorpe, M.Math         
Sub-Investigator: Bheeshma Ravi, MD,FRCPC,PhD         
Sponsors and Collaborators
Dr. Stephen Choi
Investigators
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Principal Investigator: Stephen Choi, MD,FRCPC,MSc Sunnybrook Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Stephen Choi, MD, FRCPC, MSc, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03147937    
Other Study ID Numbers: 040-2017
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Autoimmune Diseases
Inflammation
Cognitive Dysfunction
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Immune System Diseases