Orthopedic Procedures and Postoperative Delirium in Older Adults in the Czech Republic

NCT07432009 | Not Yet Recruiting

• 2 other identifiers: 2026-03-1ORTOPODCZ
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Frailty; Cognitive Impairment; Older Adults; Hip Arthroplasty; Postoperative Delirium

Keywords

ALBA test; CAM-ICU; Cognitive Screening; Geriatric Patients; Perioperative Neurocognitive Disorders; Polypharmacy; Clinical Frailty Scale; Total Hip Replacement; Observational Study; Prospective Cohort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Frailty score measured using the Clinical Frailty Scale (CFS)

  Preoperative assessment

• Number of comorbidities present preoperatively

  Preoperative assessment

• Presence of polypharmacy (>5 regular medications)

  Preoperative medication list

• Presence of preoperative anemia

  Preoperative assessment

• Type of anesthesia used (general vs. regional)

  0-72 hours after surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomas Bata Hospital, Czech Republic: lead
• Czech Clinical Research Infrastructure Network: collaborator

Study Sites (7)

University Hospital Brno - Bohunice

Brno, 62500, Czechia

Location

University Hospital Olomouc - Department of Anaesthesiology, Resuscitation and Intensive Care

Olomouc, 77900, Czechia

Location

University Hospital Ostrava - Department of Anaesthesiology, Resuscitation and Intensive Care

Ostrava, Czechia

Location

University Hospital Královské Vinohrady

Prague, 10034, Czechia

Location

University Hospital Motol

Prague, 15006, Czechia

Location

Vsetín Hospital

Vsetín, Czechia

Location

Tomas Bata Regional Hospital

Zlín, 6275, Czechia

Location

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction; Emergence Delirium

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Signs and Symptoms

Central Study Contacts

Klára Nekvindová, M.D, Ph.D.

CONTACT

+420577 551 111; nekvindova.klara@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Anesthesiology, Resuscitation and Intensive Car

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 25, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (7)