Ortopod CZ Pilot Study (Total Knee Arthoplasty and Postoperative Delirium Czech Republic
Conditions: Postoperative Delirium (POD), Perioperative Neurocognitive Disorders
Sponsor: Tomas Bata Hospital, Czech Republic

ORTOPOD PILOT STUDY 
 
MARCH 1 2025 
 
ORTOPOD PILOT STUDY is a non-randomized, non-interventional clinical study that 
addresses the issue of perioperative neurocognitive disorder (deterioration of cognitive 
functions in the preoperative and perioperative period) and its impact on the occurrence of 
postoperative delirium. 
Respondents meeting the entry criteria will undergo elective orthopaedic surgery (total hip 
arthroplasty) under general or regional anaesthesia. Preoperatively, they will be examined 
using the ALBA and POBAV tests, which serve for rapid and indicative assessment of 
cognitive functions. Furthermore, the functional capacity of patients will be assessed using 
the Clinical Frailty Scale, and depression will be evaluated using the Geriatric Depression 
Scale (questionnaire). 
 
After the procedure, during hospitalization in the ICU/PACU, screening for 
postoperative delirium will be conducted using the CAM-ICU tool. 
The aim of the pilot study is to verify the methodology and obtain baseline data on the 
incidence of cognitive dysfunction, depression, and frailty preoperatively, as well as the 
incidence of postoperative delirium in this group of patients before submitting a grant to 
AZV ČR. The main research question will be whether preoperative cognitive decline 
(according to the ALBA and POBAV tests) is associated with the occurrence of 
postoperative delirium. The second research question will be what percentage of patients 
with preoperative cognitive deficit (according to the ALBA and POBAV tests) undergo 
elective total hip arthroplasty. Secondary outcomes will include whether there are differences 
in the ALBA and POBAV test results before and after surgery (cognitive decline after 
anesthesia and surgery), whether higher Clinical Frailty Scale scores are associated with the 
occurrence of postoperative delirium, and whether the results on the Geriatric Depression 
Scale change preoperatively and postoperatively. 
 
Key words: postoperative delirium, screening, senior, risk factors, cognitive assessment, 
CAM-ICU, Amnesia Light and Brief Assessment (ALBA), POBAV 
 
 
The study involves a homogeneous group of patients undergoing total hip arthroplasty 
under general or regional anesthesia. Patients meeting the study's entry criteria, who 
have signed informed consent to participate in the study, will be included. 
 
MAIN RESEARCH QUESTION 
- 
The main research question of the ORTOPOD PILOT STUDY is whether preoperative 
cognitive decline, as assessed by the ALBA and POBAV tests, is associated with the 
occurrence of postoperative delirium in the Czech Republic?  
 
SECONDARY RESEARCH QUESTIONS:  
- 
Are higher values of the Clinical Frailty Scale before surgery (values 4, 5, or higher) 
associated with the worsening of cognitive functions? 

- 
What is the percentage of patients with cognitive impairment according to the ALBA 
and POBAV tests before knee and hip arthroplasty surgery in hospitals? 
- 
Are the results different in the ALBA and POBAV tests in the period before and after the 
surgery? 
- 
Are higher values on the Clinical Frailty Scale before surgery (values 4, 5, or higher) 
associated with a deterioration in cognitive functions? 
 
DATA COLLECTION TOOLS AND PROCEDURES 
Preoperatively:  
 
Cognitive test ALBA and POBAV 
 
Clinical Frailty Scale 
Postoperatively  
 
CAM-ICU (screening at least once a day) during hospitalization in the ICU 
ICU Hospitalization: 
 
0th postoperative day (4 hours after general anesthesia), 1st postoperative day, 2nd 
postoperative day, screening during ICU hospitalization, final screening upon 
discharge from ICU = exit screening 
PACU Hospitalization: 
 
0th postoperative day (4 hours after general anesthesia), 1st postoperative day, 2nd 
postoperative day = exit screening 
In case of postoperative delirium development: 
 
Screening 2 times a day, every 12 hours 
ENTRY CRITERIA: 
 
Age over 65 years (inclusive) 
 
Type of procedure: elective total hip arthroplasty under general or regional anesthesia 
 
ASA classification I-III 
 
Absence of sensory impairment (blindness, deafness, deaf-muteness) 
 
Postoperative hospitalization in the intensive care unit, post-anesthesia care unit 
(PACU) 
 
EXCLUSION CRITERIA: 
 
Glasgow Coma Scale 14 or less 
 
Limited legal capacity 
 
Known psychiatric illness with the use of psychiatric medications 

 
Effect of premedication, psychiatric, and analgesic-sedative drugs (at the time of 
cognitive function testing) 
 
Active oncological disease 
 
Chronic use of strong opioids 
 
Re-operation