Cognitive Changes After Major Joint Replacement

NCT02964221 | Completed

• 1 other identifier: 045-2015
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

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; Mild Cognitive Impairment; Delirium; Cognitive Deficit; Cognitive Change; Working Memory

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery

  Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery

  4.5 months after surgery

Secondary Outcomes (3)

• Proportion of patients developing severe cognitive dysfunction at 4.5 months after surgery (defined as CBB score less than 80)

  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

  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

  4.5 months after surgery

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: Yes
• 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 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

MeSH Terms

Conditions

Postoperative Cognitive Complications; Cognitive Dysfunction; Delirium; Cognition Disorders

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Stephen Choi, MD,FRCPC,MSc

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, University of Toronto; Staff Anesthesiologist and Director of Clinical Research, Department of Anesthesia, Sunnybrook Health Sciences Centre

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 16, 2016
• Study Start: June 15, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05