Ortopod CZ Pilot Study

NCT06869876 | Completed

• 1 other identifier: Č.j: 2025-01
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium (POD); Perioperative Neurocognitive Disorders

Keywords

postoperative delirium; CAM- ICU; ALBA; POBAV; Amnesia Light and Brief Assessment,; screening; cognitive assessment; risk factors; seniors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Clinical frailty scale - assessment preoperatively

  one week before surgery

• Age

  one week before surgery

• ALBA - cognitive assessment postoperatively

  3rd day after surgery

• POBAV - cognitive assessment postoperatively

  3rd day after surgery

Other Outcomes (17)

• Gender

  one week before surgery

• ASA status preoperatively

  one week before surgery

• The Geriatric Depression Scale (GDS)

  one week before surgery

Study Arms (1)

Total knee arthroplasty

Patients above 65 years old undergoing elective total hip arthroplasty.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomas Bata Hospital, Czech Republic: lead

Study Sites (1)

Tomas Bata Hospital

Zlín, 76001, Czechia

Location

Related 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

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief for Science, Teaching, and Research

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 11, 2025
• Study Start: March 1, 2025
• Primary Completion: October 22, 2025
• Study Completion: October 25, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)