Recruiting

Observational Study

Sponsor:

McMaster University

Code:

NCT05614271

Conditions

Postoperative Cognitive Dysfunction

Chronic Post Operative Pain

Satisfaction, Patient

Coping Behavior

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

"Brain damage" and "memory loss" are main concerns of people undergoing surgery. In fact, many older people undergoing different types of non-cardiac surgeries (including orthopedic surgeries) present a significant decline in their cognition (i.e. the way people use their brain to think, take action, make decision, and remember) 1 year after surgery. This is called postoperative cognitive dysfunction (POCD), and is significantly more frequent (as many as 30% of patients aged 65 or older) than what we would expect in non-surgical patients with similar age and comorbidities. Causes and mechanisms of POCD are poorly understood. Pain after surgery is also very frequent and can persist for a long time (i.e. persistent postsurgical pain, PPSP), requiring chronic medications including narcotics. Knee surgery is more often offered as a treatment in older patients with osteoarthritis, who often come to surgery after a long history of pain and impaired mobility, and who often experience PPSP. The investigators proposed to conduct a study in 200 people 55 years old or older (expected age range 55-85) who are undergoing their elective knee surgery, to evaluate the association between PPSP (and its treatment) and POCD. How cognition can interfere with resilience (coping strategies and expectations), which are also thought to influence the persistence of pain, satisfaction, and functional recovery after surgery, will also be explored. Patients will be enrolled before their surgery and followed over time, to collect data on their social and clinical characteristics, measure copying/expectations before and after surgery, and assess pain and pain medications, satisfaction and functional recovery, and cognitive performance. The study will also explore hypotheses of possible mechanisms underlying the association between PPSP and POCD, and will include interviews with a subset of the participants to explore lived experiences of pain, mobility and aging, including resilience, expectations and satisfaction with surgery.

Conditions

Postoperative Cognitive Dysfunction

Chronic Post Operative Pain

Satisfaction, Patient

Coping Behavior

Study ID

NCT05614271

Start date

Oct 1, 2021

Status verified date

Nov, 2022

Completion date

Jul 31, 2024

Anticipated

Primary completion date

Apr 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. aged 50 years or older,
2. scheduled for elective TKA or THA for osteoarthritis
3. able to provide informed consent.

Exclusion Criteria:

1. known history of dementia,
2. unavailability of tablet or computer with an internet connection for remote assessment,
3. patient unable to interact with a tablet or computer due to language, visual, or hearing impairment, or any severely limited mobility of the upper limb joints, OR
4. patient unable to understand spoken or written English.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Incidence of postoperative cognitive dysfunction (binary outcome) [ Time Frame: 6 and 12 months postoperative ]

Central Contacts and Locations

Central contacts

Maram Khaled, MBBCh, MSc

9059220293khalem3@mcmaster.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S 4L8

Contacts

Maram Khaled, MBBCh, MSc

9059220293khalem3@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Nov 14, 2022

Last verified

Nov, 2022

Keywords

  • Older adults
  • Total knee arthroplasty
  • Total hip arthroplasty
  • Postoperative cognitive dysfunction
  • chronic postsurgical pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2022-11-14.