Ortopod CZ Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-10-25

Brief Summary

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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.

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Detailed Description

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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. Preoperatively, they will be examined using the ALBA and POBAV tests, which serve for rapid and indicative assessment of cognitive functions. Furthermore, the functional capacity of patients will be assessed using the Clinical Frailty Scale, and depression will be evaluated using the Geriatric Depression Scale (questionnaire).

After the procedure, during hospitalization in the ICU/PACU, screening for postoperative delirium will be conducted using the CAM-ICU tool.

The aim of the pilot study is to verify the methodology and obtain baseline data on the incidence of cognitive dysfunction, depression, and frailty preoperatively, as well as the incidence of postoperative delirium in this group of patients before submitting a grant to AZV ČR. The main research question will be whether preoperative cognitive decline (according to the ALBA and POBAV tests) is associated with the occurrence of postoperative delirium. The second research question will be what percentage of patients with preoperative cognitive deficit (according to the ALBA and POBAV tests) undergo elective total hip arthroplasty. Secondary outcomes will include whether there are differences in the ALBA and POBAV test results before and after surgery (cognitive decline after anesthesia and surgery), whether higher Clinical Frailty Scale scores are associated with the occurrence of postoperative delirium, and whether the results on the Geriatric Depression Scale change preoperatively and postoperatively.

Conditions

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Postoperative Delirium (POD) Perioperative Neurocognitive Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Total knee arthroplasty

Patients above 65 years old undergoing elective total hip arthroplasty.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No