Orthopedic Procedures and Postoperative Delirium in Older Adults in the Czech Republic (ORTOPODCZ)

Orthopedic Procedures and Postoperative Delirium in the Czech Republic

This multicenter, prospective, non-interventional observational study (ORTOPODCZ) investigates the association between preoperative cognitive impairment and postoperative delirium (POD) in older adults undergoing elective total hip arthroplasty in the Czech Republic. Postoperative delirium is a frequent and serious neurocognitive complication in senior surgical patients and is associated with increased morbidity, mortality, prolonged hospitalization, and impaired functional and cognitive outcomes. Despite international recommendations, routine preoperative cognitive screening remains insufficiently implemented.

The study evaluates the predictive value of the ALBA test, a brief cognitive screening tool, performed during the pre-anesthetic assessment. Postoperative delirium will be assessed using the validated CAM-ICU instrument for up to 72 hours after surgery. Secondary objectives include assessing the relationship between POD and frailty, polypharmacy, comorbidities, type of anesthesia, intraoperative hemodynamics, blood loss, vasoactive support, and postoperative complications.

Approximately 300-400 participants aged ≥65 years will be enrolled across seven centers. No additional procedures, biological sampling, or deviations from standard clinical care are required. Data will be collected in REDCap and analyzed according to a predefined statistical analysis plan. The study aims to provide robust evidence supporting the integration of cognitive screening into routine preoperative evaluation and to describe feasibility and implementation requirements for the ALBA test in clinical practice.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Impairment; Postoperative Delirium; Frailty; Older Adults; Hip Arthroplasty

Detailed Description

Postoperative delirium (POD) is one of the most common perioperative neurocognitive disorders in older adults undergoing elective orthopedic procedures, particularly total hip arthroplasty. It is associated with adverse outcomes including increased morbidity, mortality, prolonged hospitalization, and long-term cognitive decline. Although international guidelines recommend routine preoperative cognitive assessment, its implementation in clinical practice remains limited.

This study builds on findings from a pilot project demonstrating the feasibility and potential predictive value of the ALBA test, a brief cognitive screening tool. The primary objective is to evaluate the association between ALBA test results (normal vs. pathological) and the occurrence of POD within 72 hours after surgery, diagnosed using the CAM-ICU instrument. Secondary objectives include assessing the relationship between POD and frailty (Clinical Frailty Scale), polypharmacy, comorbidities, preoperative anemia, type of anesthesia, intraoperative hemodynamic instability, blood loss, vasoactive medication use, reoperations, and postoperative complications.

The study is designed as a multicenter, prospective, non-interventional observational study conducted in seven hospitals in the Czech Republic. All participants will receive standard perioperative care without additional procedures or biological sampling. Cognitive screening (ALBA) will be performed during the pre-anesthetic assessment, and delirium monitoring (CAM-ICU) will be conducted at predefined intervals for up to 72 hours postoperatively. Data will be collected in REDCap and analyzed according to a predefined statistical analysis plan. The study also includes exploratory evaluation of the feasibility, acceptability, and implementation requirements of integrating the ALBA test into routine preoperative workflows.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Klára Nekvindová, M.D, Ph.D.; Phone Number: +420577 551 111; Email: nekvindova.klara@gmail.com

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • University Hospital Brno - Bohunice
    • Contact: Vrbica Kamil, M.D.; Phone Number: + 420 532 23 1111; Email: vrbica.kamil@fnbrno.cz
  • Olomouc, Czechia, 77900
    • University Hospital Olomouc - Department of Anaesthesiology, Resuscitation and Intensive Care
    • Contact: Lenka Doubravska, M.D.; Phone Number: +420 585 851 111; Email: Lenka.Doubravska@fnol.cz
  • Ostrava, Czechia
    • University Hospital Ostrava - Department of Anaesthesiology, Resuscitation and Intensive Care
    • Contact: Jan Neiser, M.D.; Phone Number: +420 597 371 111; Email: Jan.Neiser@fno.cz
  • Prague, Czechia, 10034
    • University Hospital Královské Vinohrady
    • Contact: Jiří Málek, doc, M.D., Ph.D.; Phone Number: +420267 161 111; Email: jiri.malek@fnkv.cz
  • Prague, Czechia, 15006
    • University Hospital Motol
    • Contact: Tomáš Brož, M.D.; Phone Number: +420 224 431 111; Email: tomas.broz@fnmotol.cz
  • Vsetín, Czechia
    • Vsetín Hospital
    • Contact: Marek Proksa, M.D.; Phone Number: +420571 818 111; Email: proksa@nemocnice-vs.cz
  • Zlín, Czechia, 6275
    • Tomas Bata Regional Hospital
    • Contact: Klára Nekvindová, M.D., Ph.D.; Phone Number: +420577 551 111; Email: nekvindova.klara@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Prospective cohort of patients aged 65 years and older undergoing elective total hip arthroplasty in seven hospitals in the Czech Republic. All participants receive standard perioperative care. No interventions are assigned as part of the study; only observational data are collected.

Description

Inclusion Criteria:

• Age ≥ 65 years
• Elective total hip arthroplasty in general or regional anesthesia
• ASA physical status I-III
• Ability to understand and cooperate during testing; no severe sensory impairment (compensatory aids allowed)
• Expected postoperative hospitalization in ICU, PACU, or standard ward

Exclusion Criteria:

• Glasgow Coma Scale ≤ 14
• Limited legal capacity
• Active psychiatric disorder (e.g., psychotic disorder, bipolar disorder)
• Active oncological disease
• Chronic use of strong opioids
• Premedication with anxiolytics or antipsychotics during preanesthetic evaluation
• Acute reoperation within 3 months of primary surgery
• Refusal to participate or withdrawal of consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort of older adults undergoing elective total hip arthroplasty; Prospective cohort of patients aged 65 years and older undergoing elective total hip arthroplasty in standard clinical care. All participants receive routine perioperative management. No interventions are assigned as part of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative delirium (POD)	POD will be assessed using the CAM-ICU tool. Delirium is considered present if at least one CAM-ICU assessment is positive within the first 72 hours after surgery. The outcome will be expressed as the percentage of patients with POD.	0-72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty score measured using the Clinical Frailty Scale (CFS)	Frailty will be assessed preoperatively using the Clinical Frailty Scale (CFS), which ranges from 1 to 9. Frailty is defined as CFS ≥ 4. The outcome will be expressed as the frailty score on the CFS scale. Frailty will be assessed preoperatively using the Clinical Frailty Scale (CFS), which ranges from 1 to 9. Frailty is defined as CFS ≥ 4. The outcome will be expressed as the frailty score on the CFS scale.Frailty will be assessed preoperatively using the Clinical Frailty Scale (CFS), which ranges from 1 to 9. Frailty is defined as CFS ≥ 4. The outcome will be expressed as the frailty score on the CFS scale.	Preoperative assessment
Number of comorbidities present preoperatively	Comorbidities will be recorded preoperatively, including cerebrovascular disease, cardiovascular disease, diabetes mellitus, chronic kidney disease, and others. The outcome will be expressed as the total number of comorbidities per patient.	Preoperative assessment
Presence of polypharmacy (>5 regular medications)	Polypharmacy will be assessed preoperatively and defined as the regular use of more than five medications. The outcome will be expressed as the percentage of patients meeting the definition of polypharmacy.	Preoperative medication list
Presence of preoperative anemia	Anemia will be assessed preoperatively according to local laboratory reference ranges. The outcome will be expressed as the percentage of patients who meet the definition of anemia. Anemia will be assessed preoperatively according to local laboratory reference ranges. The outcome will be expressed as the percentage of patients who meet the definition of anemia.	Preoperative assessment
Type of anesthesia used (general vs. regional)	The type of anesthesia will be recorded as general anesthesia or regional anesthesia. The outcome will be expressed as the percentage of patients receiving each anesthesia type.	0-72 hours after surgery
Duration of urinary catheterization (hours)	The duration of urinary catheterization (PMK) will be recorded daily from surgery until catheter removal. The outcome will be expressed as the total number of hours of urinary catheterization.	0-72 hours after surgery
Presence of reoperation within 72 hours after surgery	Reoperation will be assessed as a binary variable (yes/no) within 72 hours after surgery. The outcome will be expressed as the percentage of patients who undergo reoperation.	0-72 hours after surgery
Intraoperative blood loss (milliliters)	ntraoperative blood loss will be measured in milliliters as recorded by the surgical team. The outcome will be expressed as the total volume of blood loss during surgery.	Intraoperative period
Use of vasoactive drugs during surgery	The use of vasoactive drugs (e.g., noradrenaline, phenylephrine, ephedrine) will be assessed as a binary variable (yes/no) during the intraoperative period. The outcome will be expressed as the percentage of patients who receive vasoactive drugs.	Intraoperative period

Collaborators and Investigators

• Sponsor: Tomas Bata Hospital, Czech Republic
• Collaborators: Czech Clinical Research Infrastructure Network

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Polypharmacy; Observational Study; Total Hip Replacement; CAM-ICU; Clinical Frailty Scale; Geriatric Patients; Prospective Cohort; Cognitive Screening; Perioperative Neurocognitive Disorders; ALBA test
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Frailty; Emergence Delirium; Cognitive Dysfunction
• Other Study ID Numbers: 2026-03-1; ORTOPODCZ (Other Identifier: Tomas Bata regional hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because this is a multicenter observational study conducted under strict GDPR requirements. The study does not include a data-sharing framework or governance structure that would allow external access to pseudonymized datasets. Data will be used exclusively for the purposes defined in the study protocol and handled according to institutional and national data protection regulations.

Drug and device information, study documents

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