Postoperative Cognitive DysfunctionArthroCaPNCT05614271
Chronic Postsurgical Pain, Postoperative Cognitive Dysfunction and Resilience
An observational study of Postoperative Cognitive Dysfunction and Chronic Post Operative Pain, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Chronic Post Operative Pain, Satisfaction, Patient
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2021to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 50 years or older undergoing elective total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis
Who may be able to join
- aged 50 years or older,
- scheduled for elective TKA or THA for osteoarthritis
- able to provide informed consent.
Who cannot join
- known history of dementia,
- unavailability of tablet or computer with an internet connection for remote assessment,
- 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
- patient unable to understand spoken or written English.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4L8
Maura Marcucci, MD, 9055274322 ext. 40594, marcum2@mcmaster.ca
Maram Khaled, MBBCh, MSc, 9059220293, khalem3@mcmaster.ca
About this study
Official title: A Prospective Cohort Study Exploring the Associations Between Chronic Postsurgical Pain and Postoperative Cognitive Dysfunction After Elective Knee or Hip Arthroplasty
"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.
Read the detailed description
The specific study objectives are to: 1- explore the association of CPSP, pain management (opioid use), and patient satisfaction, with postoperative cognitive dysfunction (POCD), measured both as change in the Montreal Cognitive Assessment (MoCA), and through a neuropsychological test battery, 2- explore whether postoperative cognitive changes are associated with changes in neurogenesis correlates and in neurotrophic factors levels, and whether this association is mediated by changes in pain, mobility, and satisfaction, and 3- explore the association between coping strategies/expectations as measured by the Somatic Preoccupation and Coping (SPOC) questionnaire and cognitive function, and in particular the relationship between changes in SPOC and cognitive changes from preoperative to 4-6 weeks after surgery.
Investigators will recruit 150 patients, 50 years or older scheduled for knee or hip arthroplasty 1-2 weeks before surgery (baseline) and collect information about their socio-demographics data, comorbidities, frailty, anxiety, pain, and pain medications. The SPOC questionnaire is administered at baseline and repeated at 4-6 weeks after surgery. CPSP (presence and severity) and satisfaction with surgery are measured at 3, 6, and 12 months. Cognitive / neuropsychological assessments will be administered at baseline, and 4-6 weeks, 6 months, and 12 months after surgery. Blood samples for serum and RNA expression analysis of biomarkers will be longitudinally collected with the same timeline.
- Conditions
- Postoperative Cognitive Dysfunction, Chronic Post Operative Pain, Satisfaction, Patient, Coping Behavior
- Keywords
- Older adults, Total knee arthroplasty, Total hip arthroplasty, Postoperative cognitive dysfunction, chronic postsurgical pain
- Medical subject headings
- Postoperative Cognitive Complications, Pain, Postoperative, Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative cognitive dysfunction (binary outcome)
defined as a >=2 point decline in MoCA scores.
Measured: 6 and 12 months postoperative
Secondary outcomes (5)
Changes in the Mnemonic Similarity Test scores
Participants are first engaged in an encoding phase then a subsequent recognition test with a 3-choice response; exact repetitions of earlier items, lures (similar but not identical to earlier items), and novel foils. During the test, participants are asked to identify each item as "Old," "Similar," or "New". The lure discrimination index (which measures mnemonic discrimination) is calculated as the difference between the rate of "Similar" responses given to the lure items minus "Similar" responses given to the foils. Typically, 'normal' aging is associated with a decline in mnemonic discrimination (identifying lure objects that are similar to memory set objects as "similar") with preserved recognition memory (identifying repeated memory set objects as "old"). The MST version used in the study is a validated modified online version of MST adapted to increase the efficiency of the test.
Measured: 4-6 weeks and 6 and 12 months
Changes in the Visual Paired Associates Learning (PAL) test
A computer task that assesses visual memory and new learning by testing a participant's memory for object location pairs. Boxes are displayed on the screen and are opened in a randomized order. One or more of them will contain a pattern. The patterns are then displayed in the middle of the screen, one at a time, and the participant must touch the box where the pattern was originally located. If the participant makes an error, the patterns are represented by their locations. The difficulty increases throughout the test. The average accuracy across the last two completed levels will be analyzed
Measured: 4-6 weeks and 6 and 12 months
Changes in the Rapid serial Visual Presentation (RVP) test
A white box is shown in the centre of the screen, inside which digits from 2 to 9 appear in a pseudo-random order, at the rate of 100 digits per minute. Participants are requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8). When the participant sees the target sequence they must respond by selecting the button in the centre of the screen as quickly as possible. The level of difficulty varies with either one- or three-target sequences that the participant must watch for at the same time. The average accuracy throughout the task will be analyzed.
Measured: 4-6 weeks and 6 and 12 months
Changes in the Stroop color word color interference task CWIT
CWIT has the standard color naming, word reading, and color-word interference trials,in addition to additional trial requiring the examinee to switch between inhibitory and non-inhibitory responses. Process measures enable assessment of general difficulties. Condition 1: Color Naming, Condition 2: Word Reading, Condition 3: Inhibition, Condition 4: Inhibition/ Switching requires adequate naming speed, reading speed, verbal inhibition, and cognitive flexibility.and Scores will include the time needed to complete each condition, the number of errors and the number of self-corrected errors
Measured: 4-6 weeks and 6 and 12 months
Changes in the N-back test
Participants are shown a series of numbers on the screen and are asked to enter the number they saw two numbers ago. The outcome measures are correct detection and reaction times.
Measured: 4-6 weeks and 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Oct 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- The McMaster Institute for Research on Aging (MIRA), Michael G. DeGroote Institute for Pain Research and Care (IPRC)
- Responsible party
- Principal investigator, Maura Marcucci, McMaster University
- Investigators
- Maura Marcucci, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614271
- Sponsor's protocol ID
- 13598
- Acronym
- ArthroCaP
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study Exploring the Associations Between Chronic Postsurgical Pain and Postoperative Cognitive Dysfunction After Elective Knee or Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05614271
- Acronym / sponsor ID
- ArthroCaP / 13598
- Conditions
- Postoperative Cognitive Dysfunction, Chronic Post Operative Pain, Satisfaction, Patient, Coping Behavior
- Keywords
- Older adults, Total knee arthroplasty, Total hip arthroplasty, Postoperative cognitive dysfunction, chronic postsurgical pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- The McMaster Institute for Research on Aging (MIRA), Michael G. DeGroote Institute for Pain Research and Care (IPRC)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
Detailed description
The specific study objectives are to: 1- explore the association of CPSP, pain management (opioid use), and patient satisfaction, with postoperative cognitive dysfunction (POCD), measured both as change in the Montreal Cognitive Assessment (MoCA), and through a neuropsychological test battery, 2- explore whether postoperative cognitive changes are associated with changes in neurogenesis correlates and in neurotrophic factors levels, and whether this association is mediated by changes in pain, mobility, and satisfaction, and 3- explore the association between coping strategies/expectations as measured by the Somatic Preoccupation and Coping (SPOC) questionnaire and cognitive function, and in particular the relationship between changes in SPOC and cognitive changes from preoperative to 4-6 weeks after surgery.
Investigators will recruit 150 patients, 50 years or older scheduled for knee or hip arthroplasty 1-2 weeks before surgery (baseline) and collect information about their socio-demographics data, comorbidities, frailty, anxiety, pain, and pain medications. The SPOC questionnaire is administered at baseline and repeated at 4-6 weeks after surgery. CPSP (presence and severity) and satisfaction with surgery are measured at 3, 6, and 12 months. Cognitive / neuropsychological assessments will be administered at baseline, and 4-6 weeks, 6 months, and 12 months after surgery. Blood samples for serum and RNA expression analysis of biomarkers will be longitudinally collected with the same timeline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 50 years or older undergoing elective total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis
Key inclusion criteria (3 listed)
- aged 50 years or older,
- scheduled for elective TKA or THA for osteoarthritis
- able to provide informed consent.
Key exclusion criteria (4 listed)
- known history of dementia,
- unavailability of tablet or computer with an internet connection for remote assessment,
- 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
- patient unable to understand spoken or written English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative cognitive dysfunction (binary outcome)
Time frame: 6 and 12 months postoperative
defined as a >=2 point decline in MoCA scores.
5 secondary outcomes
Changes in the Mnemonic Similarity Test scores
Time frame: 4-6 weeks and 6 and 12 months
Changes in the Visual Paired Associates Learning (PAL) test
Time frame: 4-6 weeks and 6 and 12 months
Changes in the Rapid serial Visual Presentation (RVP) test
Time frame: 4-6 weeks and 6 and 12 months
Changes in the Stroop color word color interference task CWIT
Time frame: 4-6 weeks and 6 and 12 months
Changes in the N-back test
Time frame: 4-6 weeks and 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maura Marcucci, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction and Chronic Post Operative Pain, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maura Marcucci, MD (9055274322 ext. 40594, marcum2@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative cognitive dysfunction (binary outcome) (time frame: 6 and 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022; AzTrials last refreshed its copy on 31 Oct 2026.