FrailtyORTOPODCZNCT07432009
Orthopedic Procedures and Postoperative Delirium in Older Adults in the Czech Republic
An observational study of Frailty and Cognitive Impairment, run by Tomas Bata Hospital, Czech Republic at 7 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Cognitive Impairment, Older Adults
- How many people
- 400 participants
- Where
- 7 sitesCzechia
- Study dates
- 24 Apr 2026to 31 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Czechia7 sites, 7 recruiting
- Not yet recruiting
University Hospital Brno - Bohunice
Brno, 62500
Vrbica Kamil, M.D., + 420 532 23 1111, vrbica.kamil@fnbrno.cz
- Not yet recruiting
University Hospital Olomouc - Department of Anaesthesiology, Resuscitation and Intensive Care
Olomouc, 77900
Lenka Doubravska, M.D., +420 585 851 111, Lenka.Doubravska@fnol.cz
- Not yet recruiting
University Hospital Ostrava - Department of Anaesthesiology, Resuscitation and Intensive Care
Ostrava
Jan Neiser, M.D., +420 597 371 111, Jan.Neiser@fno.cz
- Not yet recruiting
University Hospital Královské Vinohrady
Prague, 10034
Jiří Málek, doc, M.D., Ph.D., +420267 161 111, jiri.malek@fnkv.cz
- Not yet recruiting
University Hospital Motol
Prague, 15006
Tomáš Brož, M.D., +420 224 431 111, tomas.broz@fnmotol.cz
- Not yet recruiting
Vsetín Hospital
Vsetín
Marek Proksa, M.D., +420571 818 111, proksa@nemocnice-vs.cz
- Recruiting
Tomas Bata Regional Hospital
Zlín, 6275
Klára Nekvindová, M.D., Ph.D., +420577 551 111, nekvindova.klara@gmail.com
About this study
Official title: 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.
Read the 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.
- Keywords
- ALBA test, CAM-ICU, Cognitive Screening, Geriatric Patients, Perioperative Neurocognitive Disorders, Polypharmacy, Clinical Frailty Scale, Total Hip Replacement, Observational Study, Prospective Cohort
- Medical subject headings
- Frailty, Cognitive Dysfunction, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-72 hours after surgery
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start24 Apr 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomas Bata Hospital, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Czech Clinical Research Infrastructure Network
- Responsible party
- Principal investigator, Klára Nekvindová, Tomas Bata Hospital, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432009
- Sponsor's protocol ID
- 2026-03-1
- Other IDs
- ORTOPODCZ
- Acronym
- ORTOPODCZ
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthopedic Procedures and Postoperative Delirium in the Czech Republic
- ClinicalTrials.gov ID
- NCT07432009
- Acronym / sponsor ID
- ORTOPODCZ / 2026-03-1
- Keywords
- ALBA test, CAM-ICU, Cognitive Screening, Geriatric Patients, Perioperative Neurocognitive Disorders, Polypharmacy, Clinical Frailty Scale, Total Hip Replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tomas Bata Hospital, Czech RepublicUniversity, hospital or other
- Collaborators
- Czech Clinical Research Infrastructure Network
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Glasgow Coma Scale ≤ 14
- Limited legal capacity
- Active psychiatric disorder (e.g., psychotic disorder, bipolar disorder)
- Active oncological disease
- Chronic use of strong opioids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative delirium (POD)
Time frame: 0-72 hours after surgery
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.
9 secondary outcomes
Frailty score measured using the Clinical Frailty Scale (CFS)
Time frame: Preoperative assessment
Number of comorbidities present preoperatively
Time frame: Preoperative assessment
Presence of polypharmacy (>5 regular medications)
Time frame: Preoperative medication list
Presence of preoperative anemia
Time frame: Preoperative assessment
Type of anesthesia used (general vs. regional)
Time frame: 0-72 hours after surgery
Duration of urinary catheterization (hours)
Time frame: 0-72 hours after surgery
Presence of reoperation within 72 hours after surgery
Time frame: 0-72 hours after surgery
Intraoperative blood loss (milliliters)
Time frame: Intraoperative period
Use of vasoactive drugs during surgery
Time frame: Intraoperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Cognitive Impairment, run by Tomas Bata Hospital, Czech Republic at 7 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Klára Nekvindová, M.D, Ph.D. (+420577 551 111, nekvindova.klara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (POD) (time frame: 0-72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.