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NCT07432009: ORTOPODCZ

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

Not yet recruiting Last updated 25 February 2026
What this trial tests

trial in Frailty in 400 participants. Not yet recruiting.

Timeline
1 April 2026
Primary endpoint
31 December 2029
31 March 2030

Quick facts

Lead sponsorTomas Bata Hospital, Czech Republic
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment400
Start date1 April 2026
Primary completion31 December 2029
Estimated completion31 March 2030
Sites7 locations across Czechia

Conditions studied

Sponsor

Tomas Bata Hospital, Czech Republic

Who can join

65 and older, any sex, with Frailty or Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Frailty

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Data sources for this page

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