Ortopod CZ Pilot Study (ORTOPODCZ)

Ortopod CZ Pilot Study (Total Knee Arthoplasty and Postoperative Delirium Czech Republic

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium (POD); Perioperative Neurocognitive Disorders

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Czechia
  • Zlín, Czechia, 76001
    • Tomas Bata Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

"Respondents meeting the entry criteria will undergo elective orthopedic surgery (total hip replacement) under general or regional anesthesia.

Description

Inclusion Criteria:

• Age over 65 years (inclusive)

  • Type of procedure: elective hip replacement (TEP) under general or regional anesthesia
• ASA classification I-III
• Absence of sensory impairment (blindness, deafness, deaf-blindness)

Exclusion Criteria:

• Glasgow Coma Scale of 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Total knee arthroplasty; Patients above 65 years old undergoing elective total hip arthroplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALBA - cognitive assessment preoperatively	Amnesia Light and Brief Assessment (ALBA) is an ultra-brief and universal cognitive test suitable for assessing cognitive impairment, dementia, and other conditions. Test consists of a one-time encoding of a six-word sentence "Indian summer brings the first morning frost.", sequential demonstration of six gestures and their immediate recall in any order (TEGEST) and finally recall of as many correct words as possible of the original sentence. The ALBA score norm for the sum of recalled words and gestures is 6-12 points (at least 50% of the maximum), mild impairment is 4-5 points, and severe impairment is 0-3 points. For more educated individuals (with a high school diploma or more, or 15 years of education or more), the ALBA score norm is 8-12 points..	one week before surgery
POBAV - cognitive assessment preoperatively	POBAV is an abbreviationof Czech title Picture naming and their recall. The test consists of two parts. The persons are to name each of the 20 picture in one word and remember these picture names. When they finish naming the pictures, then they are asked to recall and write as many picture names as they can during one minute. Evaluation of Part 1: After completing the entire test, determine the number of naming errors (images not named at all and incorrectly named). Most older individuals should make a naming error in no more than one image. Evaluation of Part 2: The number of correctly recalled images will be determined. The number of errors from the total number of written picture names will be substracted to get the number of correctly recalled image names. Most older individuals should recall 6 or more correct image names, while individuals with a high school diploma should recall 7 image names.	one week before surgery
Postoperative CAM-ICU	CAM-ICU scale: FEATURE 1: Alteration/Fluctuation in Mental Status - Present/not present FEATURE 2: Inattention 1: Alteration/Fluctuation in Mental Status -If number of errors >2 = present /not present FEATURE 3: Altered Level of Consciousness (LOC) - present/not present FEATURE 4: Disorganized Thinking - present/not present Features 1 and 2 are both present and either Features 3 or 4 are present: Delirium present CAM-ICU is positive, delirium is present	0. postoperative day, 1. postoperative day, 2. postoperative day.
ALBA, POBAV and CAM - ICU	The research question is: "Is the reduction in cognitive functions according to the ALBA and POBAV tests associated with the occurrence of postoperative delirium in the Czech Republic?	one week before surgery,0. postoperative day, 1. postoperative day, 2. postoperative day.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical frailty scale - assessment preoperatively	Clinical frailty scale is a way to summarize the overall level of fitness or frailty of an older adult after they had been evaluated by an experienced clinician. Frailty score ranging from 1 (very fit) to 9 (terminally ill).; = very fit; = well; = managing well; = vulnerable; = mildly frail; = moderately frail; = severely frail; = very severely frail; = terminally ill Research questions: Are higher values of the Clinical Frailty Scale before surgery (values 4, 5, or higher) associated with the occurrence of postoperative delirium in Czech Republic? Are higher values of the Clinical Frailty Scale before surgery (values 4, 5, or higher) associated with the worsening of cognitive functions	one week before surgery
Age	Age of the patients undergoing elective tottal hip arthroplasty, in years.	one week before surgery
ALBA - cognitive assessment postoperatively	Amnesia Light and Brief Assessment (ALBA) is an ultra-brief and universal cognitive test suitable for assessing cognitive impairment, dementia, and other conditions. Test consists of a one-time encoding of a six-word sentence "Indian summer brings the first morning frost.", sequential demonstration of six gestures and their immediate recall in any order (TEGEST) and finally recall of as many correct words as possible of the original sentence. The ALBA score norm for the sum of recalled words and gestures is 6-12 points (at least 50% of the maximum), mild impairment is 4-5 points, and severe impairment is 0-3 points. For more educated individuals (with a high school diploma or more, or 15 years of education or more), the ALBA score norm is 8-12 points..	3rd day after surgery
POBAV - cognitive assessment postoperatively	POBAV is an abbreviationof Czech title Picture naming and their recall. The test consists of two parts. The persons are to name each of the 20 picture in one word and remember these picture names. When they finish naming the pictures, then they are asked to recall and write as many picture names as they can during one minute. Evaluation of Part 1: After completing the entire test, determine the number of naming errors (images not named at all and incorrectly named). Most older individuals should make a naming error in no more than one image. Evaluation of Part 2: The number of correctly recalled images will be determined. The number of errors from the total number of written picture names will be substracted to get the number of correctly recalled image names. Most older individuals should recall 6 or more correct image names, while individuals with a high school diploma should recall 7 image names.	3rd day after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender	Gender of the patient undergoing elective total hip arhroplasty. Women or men.	one week before surgery
ASA status preoperatively	The American Society of Anesthesiologists (ASA) physical status classification system is a grading system to determine the health of a person before a surgical procedure that requires anesthesia ASA I = a normal healthy patient ASA II = a patient with mild systematic disease ASA III = a patient with severe systematic disease	one week before surgery
The Geriatric Depression Scale (GDS)	The Geriatric Depression Scale (GDS) is a self-report measure of depression in older adults. Users respond in a "Yes/No" format. Scoring: 0 or 1 point (1 point is awarded for the presence of a depressive symptom). 10 questions indicate depression when answered "Yes," and 5 questions (Nos. 1, 5, 7, 11, 13) indicate depression when answered "No." The questionnaire can thus score a maximum of 15 points.0-5 normal mood, 6-10 mild depression, 11+ severe depression	one week before surgery
Education	Education of the patients in years.	one week before surgery
Duration time of the operation	Cumulatively in minutes. time will be indicated according to the operating protocol	end of the operation
Blood pressure value during surgery	Blood pressure values at the beginning and end of the procedure, in mmHg (in anesthesia record). Hypotension blood pressure 30% lower than baseline pressure, reported cumulatively in minutes.	end of the operation
Spo2 during surgery	Value at the beginning and end of the procedure (%), desaturation yes/no (Spo2 94 and less%), duration (in minutes).	end of the operation
Blood loss during surgery	Blood loss cumulative for the procedure in milliliters.	end of the operation
Blood glucose level during surgery	Sample of blood glucose level taken as part of standard practice, mmol/l.	end of the operation
Circulatory instability during surgery	Yes or no. Yes when it is necessary to administer norepinephrine or ephedrine.	end of the operation
Norepinephrine during surgery	Highest dose of noradrenaline during operation, in µg/kg/min. Total duration of norepinephrine administration during surgery in minutes).	end of the operation
Blood loss after the procedure	Cumulatively in milliliters, during the CAM-ICU screening period (postoperative day 0, postoperative day 1, postoperative day 2). In case of CAM-ICU positivity, the blood loss assessment continues during the CAM-ICU screening period. Blood loss assessment once a day. Evaluated will be amount of transfusion units and , Types of blood derivatives given: Deleukocytized erythrocytes, Prothrombin Complex Concentrate (PCC), Pathogen-inactivated plasma, Fresh frozen plasma, fibrinogen, Platelets from buffy coat mixed deleukocytized in replacement solution.	3rd day after operation
Postoperative nausea and vomiting	Yes or no. Assessment 0. postoperative day.	0. postoperative day
Administered hypnotic or/and anxiolytic	Yes or no. During the CAM-ICU screening period (postoperative day 0, postoperative day 1, postoperative day 2.	3rd day after operation
Circulatory instability after the procedure	Yes or no. Y (yes=when it is necessary to administer norepinephrine). During the CAM-ICU screening period (postoperative day 0, postoperative day 1, postoperative day 2.	3rd day after operation
Norepinephrine after the procedure	Highest dose of noradrenaline during the day, in µg/kg/min. Total duration of norepinephrine administration after the procedure (in minutes). During the CAM-ICU screening period (postoperative day 0, postoperative day 1, postoperative day 2).	3rd day after operation
Necessity of re-operation within 3 days	Yes or no.	3rd day after operation

Collaborators and Investigators

• Sponsor: Tomas Bata Hospital, Czech Republic

Publications and helpful links

Helpful Links

• European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium
• TEGEST as promising tool for assessing the risk of perioperative neurocognitive disorders

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): October 22, 2025
• Study Completion (Actual): October 25, 2025

Study Registration Dates

• First Submitted: March 1, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: risk factors; screening; postoperative delirium; cognitive assessment; seniors; CAM- ICU; ALBA; POBAV; Amnesia Light and Brief Assessment,
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: Č.j: 2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No