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

NCT03147937 | Active Not Recruiting

• 1 other identifier: 040-2017
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction; Cognitive Impairment; Mild Cognitive Impairment; Delirium; Cognitive Decline; Cognitive Change; Working Memory; Autoimmune Diseases; Inflammation

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with Cognigram score decreasing by > 2 SDs from baseline at 4.5

  Proportion of patients with Cognigram score decreasing by \> 2 SDs from baseline at 4.5

  4.5 months from baseline

Secondary Outcomes (5)

• 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

  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

  4.5 months from baseline

• Effect of postoperative complications on postoperative cognitive changes at 4.5 months

  4.5 months from baseline

Interventions

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• All patients ≥ 50 years of age undergoing elective total hip or knee arthroplasty at Sunnybrook Health Sciences Centre

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Stephen Choi: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• Choi S, Avramescu S, Orser BA, Au S. Protocol for a prospective cohort study of assessing postoperative cognitive changes after total hip and knee arthroplasty in the Greater Toronto area. BMJ Open. 2019 Feb 24;9(2):e024259. doi: 10.1136/bmjopen-2018-024259.

  PMID: 30804030 DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications; Cognitive Dysfunction; Delirium; Autoimmune Diseases; Inflammation

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Stephen Choi, MD,FRCPC,MSc

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, FRCPC, MSc

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: May 1, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

CA (1)