Odense University Hospital, Svendborg Hospital
Svendborg, 5700, Denmark
Location status: Recruiting
Location contact
Abdullahi Abdirisak Hirsi, MD
CONTACT
Abdullahi Abdirisak Hirsi, MD
PRINCIPAL_INVESTIGATOR
Martin Lindberg-Larsen, Professor
CONTACT
NCT Number: NCT07598552
The goal of this observational study is to explore early cognitive changes in patients aged 70 years or older undergoing same-day discharge after hip or knee replacement surgery. The main question it aims to answer is:
Does patients experience cognitive changes in cognitive test performance from before surgery to the first day after surgery?
Participants will:
* Complete a cognitive test battery virtually about 14 days before surgery, and on the first and seventh day after their operation. * Record pain levels and pain medicine use during the first week after surgery
Interested in participating?
Request Info70 year and older
All sexes
Observational
Svendborg, 5700, Denmark
Location status: Recruiting
Abdullahi Abdirisak Hirsi, MD
CONTACT
Abdullahi Abdirisak Hirsi, MD
PRINCIPAL_INVESTIGATOR
Martin Lindberg-Larsen, Professor
CONTACT
Introduction Background Postoperative cognitive dysfunction (POCD) is a prevalent complication in elderly patients and has significant clinical and socioeconomic consequences, delayed recovery, decreased quality of life, persistent neurocognitive disorders and increased morbidity and mortality within the first year of surgery . The pathogenesis remains poorly understood, partly due to varying diagnostic approaches and methodologies. Nevertheless, there is consensus that POCD is multifactorial influenced by factors such as advanced age, sleep disturbances, and inadequate perioperative pain management .
Sleep deprivation, in particular, can exacerbate hyperalgesia, impair cognition, and lead to increased respiratory and cardiac risks due to REM sleep rebound. Fast-track surgical protocols, which emphasize multimodal rehabilitation-including regional anesthesia, opioid-sparing analgesia, and early mobilization-have been shown to reduce postoperative pain, sleep disturbances, and the risk of delirium. These protocols have reduced the average length of hospital stays worldwide. In Denmark length of hospital stay after total hip arthroplasty (THA), total knee arthroplasty (TKA) and unicompartmental knee (UKA) is now only one day and an increasing number of patients are discharged on the day of surgery. Same-day discharge enable earlier return to a familiar environment and potentially enhanced pathophysiological recovery.
No studies have described early postoperative cognitive test performance in elderly patients undergoing same-day discharge hip and knee arthroplasty. This study therefore aims to address this knowledge gap by examining early cognitive changes in patients aged ≥70 years after same-day discharge hip and knee arthroplasty.
Aim The primary aim of this study is to report early cognitive changes measured with Symbol Digit Modality Test (SDMT) in patients over 70 years undergoing same-day discharge THA, TKA and UKA. Secondary, to report cognitive changes using the Stroop Color Test and verbal fluency test as well as patient's perceived cognitive function. As patients return home on the day of surgery in this contemporary same-day discharge arthroplasty setting, we hypothesize that early postoperative changes in cognitive performance will be limited compared with earlier fast-track studies with a longer median length of stay (LOS).
Methods
The cognitive tests:
The cognitive tests will be administered by research assistants with prior research experience.
Eligible participants will be recruited from the outpatient clinic. Testing will be performed virtually with the patients being at home. The patients will receive instructions to complete all sessions in the same quiet room and on the same device, to keep environmental stimuli (lighting, background noise, screen distance, seating, posture, and internet conditions) constant and thereby reduce within-subject variance and practice effects. The baseline test will be administered 14 days +- 3 days prior to surgery to avoid preoperative anxiety effects. Postoperatively, testing will be carried out on postoperative day 1 and day 7. More frequent testing is avoided to reduce practice effects.
Only patients receiving spinal anesthesia will be included to minimize confounding from general anesthesia and to reflect current fast-track practice. Spinal anesthesia is administered using a relatively short-acting blockade bupivacaine 5 mg/mL, 2.5 mL (12.5 mg) in THA, while for primary TKA and UKA, bupivacaine 5 mg/mL, 2 mL (10 mg) . Standard local infiltration analgesia (LIA) will be used with 150 mL ropivacaine 2 mg/mL in knee arthroplasties but not in hip arthroplasties . Peripheral nerve blocks are not used. Patients will also receive cloxacillin 2 gr, methylprednisolone 125 mg and 1 gr tranexamic acid intravenously immediately prior to skin incision.
Postoperative pain management and other medication Postoperative pain management will follow a standardized multimodal, opioid-sparing regimen. All patients will receive paracetamol (1 g × 4) in combination with ibuprofen 400 mg × 3 (7 days) for THA patients in and 400 mg × 4 (14 days) for TKA and UKA patients, unless contraindicated.
Opioids will be reserved as rescue medication, administered only on an "as needed" basis. Morphine 10 mg tablets will be used as first-line rescue analgesia, with oxycodone 5 mg as an alternative for patients who do not tolerate morphine.
Data Source:
A REDCap database has been established in collaboration with the Open Patient Data Explorative Network (OPEN) at Odense University Hospital (25). Patients scheduled for hip and knee arthroplasty at Svendborg hospital and included in the planned study will be enrolled in the database following informed consent. Patient's baseline database will be registered on comorbidities and medication use entered by trained research staff.
Statistics and sample size Although this is an exploratory study, the sample size was guided by considerations from both the literature and our pilot planning. Because the design is paired, each participant serves as their own control (baseline vs. postoperative assessment). For the SDMT we assumed a minimal clinically important difference (MCID) of 4 points , a within-subject correlation of 0.85 between baseline and postoperative scores, and a standard deviation of 7.5 . With a two-sided alpha of 0.05 and 80% power, this corresponds to approximately 14 participants with complete paired measurements per subgroup (THA, TKA, and UKA) if analyses are performed separately. To account for anticipated dropout/non-same-day discharge, we will aim to enroll 16 patients per subgroup to obtain 14 participants with complete paired measurements.
Continuous variables will be summarized as mean with standard deviation (SD) and range if approximately normally distributed; otherwise as median with interquartile range (IQR) and range. Categorical variables will be described using absolute and relative frequencies (n, %).
Patient involvement Patients who have previously undergone hip or knee arthroplasty were involved in the design process. Their feedback informed the research questions and outcome measures, ensuring relevance and patient-centeredness. During pilot testing, participating patients also provided input on the planned assessment procedures and overall feasibility, which further informed methodological adjustments.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From baseline, 14 days before surgery, and postoperative day 1.
The SDMT is a validated neuropsychological tool that measures processing speed, attention, and visual scanning. The SDMT will be administered virtually as an oral 90-second test. The primary metric will be the SDMT score, defined as the number of correct digit substitutions completed within 90 seconds
Time frame: From baseline, 14 days before surgery, and postoperative day 7.
The SDMT is a validated neuropsychological tool that measures processing speed, attention, and visual scanning. The SDMT will be administered virtually as an oral 90-second test. The primary metric will be the SDMT score, defined as the number of correct digit substitutions completed within 90 seconds
Time frame: From baseline, 14 days before surgery, and postoperative day 1.
The Stroop Color-Word Test is a validated measure of selective attention and susceptibility to interference. The primary metrics will be completion time (seconds) and number of errors recorded for each session.
Time frame: From baseline, 14 days before surgery, and postoperative day 7.
The Stroop Color-Word Test is a validated measure of selective attention and susceptibility to interference. The primary metrics will be completion time (seconds) and number of errors recorded for each session.
Time frame: From baseline, 14 days before surgery, and postoperative day 1.
Verbal fluency assessment is a validated test which assesses executive function, semantic memory, and language. In our test a semantic (animal naming) and a phonemic (letter S) fluency task were used, each administered for 60 seconds. Number of correct responses for each task will be registered.
Time frame: From baseline, 14 days before surgery, and postoperative day 7.
Verbal fluency assessment is a validated test which assesses executive function, semantic memory, and language. In our test a semantic (animal naming) and a phonemic (letter S) fluency task were used, each administered for 60 seconds. Number of correct responses for each task will be registered.
Time frame: Postoperative day 1.
A brief two-item subjective cognitive questionnaire will be administered to assess patient's perceived cognitive changes and to identify any discrepancy between subjective experience and objective neuropsychological test performance.
Time frame: From postoperative day 1 and postoperative day 7.
A brief two-item subjective cognitive questionnaire will be administered to assess patient's perceived cognitive changes and to identify any discrepancy between subjective experience and objective neuropsychological test performance.
Time frame: End of surgery until discharge from the hospital on the day 1 of surgery (DOS)
Measured in milligrams
Time frame: Postoperative day 1 to postoperative day 7.
Measured in milligrams.
Time frame: From postoperative day 1 to postoperative day 7.
Patients will record pain intensity using an 11-point numeric rating scale (NRS, 0-10) in a pain diary.
Time frame: From postoperative day 1 to postoperative day 7.
Patients will record pain intensity using an 11-point numeric rating scale (NRS, 0-10) in a pain diary. Pain will be assessed defined as a standardized 5-m walk test.
Contact information is provided by the study sponsor or research team.
Odense University Hospital
Other
Early Cognitive Changes in Patients Aged 70 Years or Older After Same-day Discharge Hip and Knee Arthroplasty: A Prospective Cohort Study
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