- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03147937
Cognitive Changes After Major Joint Replacement - Full Trial (Cognigram 2)
Assessing Postoperative Cognitive Changes After Major Joint Arthroplasty: A Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Occurrence of major acute postoperative complications (e.g., cardiac event, pulmonary embolus, renal failure, pneumonia, prosthetic joint infection)
- Pre-existing mild cognitive impairment (MCI)
- Post-operative delirium
- 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:
- Establish cognitive trajectories after major lower extremity joint arthroplasty and the incidence of both post-operative delirium and POCD
- Test Main Study Hypothesis (see above)
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Stephen Choi, MD,FRCPC,MSc
- Phone Number: 4864 416-480-6100
- Email: stephen.choi@sunnybrook.ca
Study Contact Backup
- Name: Shelly Au, PhD, PMP
- Phone Number: 89607 416-480-6100
- Email: shelly.au@sunnybrook.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- SunnyBrook Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4.5 months from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4.5 months from baseline
|
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
|
4.5 months from baseline
|
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
|
4.5 months from baseline
|
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
|
4.5 months from baseline
|
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
|
4.5 months from baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephen Choi, MD,FRCPC,MSc, Sunnybrook Research Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 040-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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