Pilot study on cognitive function and postoperative delirium in hip replacement patients
Ortopod CZ Pilot Study (Total Knee Arthoplasty and Postoperative Delirium Czech Republic
Tomas Bata Hospital, Czech Republic · NCT06869876
This study is testing how pre-surgery thinking skills affect the chances of confusion after hip replacement surgery in older patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Tomas Bata Hospital, Czech Republic (other) |
| Locations | 1 site (Zlín) |
| Trial ID | NCT06869876 on ClinicalTrials.gov |
What this trial studies
The ORTOPOD Pilot Study is an observational study focusing on the relationship between preoperative cognitive function and the incidence of postoperative delirium in patients undergoing elective total hip arthroplasty. Participants aged 65 and older will be assessed for cognitive decline using the ALBA and POBAV tests, as well as evaluated for functional capacity and depression. Following surgery, patients will be monitored for signs of postoperative delirium using the CAM-ICU tool. The study aims to gather baseline data to understand the impact of cognitive dysfunction on postoperative outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 65 and older scheduled for elective total hip arthroplasty.
Not a fit: Patients with significant cognitive impairment, psychiatric illnesses, or those undergoing re-operation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing postoperative delirium in elderly patients undergoing hip replacement surgery.
How similar studies have performed: Other studies have explored cognitive function and postoperative outcomes, suggesting potential benefits, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zlín
- Tomas Bata Hospital — Zlín, Czechia (RECRUITING)
Study contacts
- Study coordinator: Klára Nekvindová, M.D., Ph.D.
- Email: nekvindova.klara@gmail.com
- Phone: +420 577 551 111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Delirium, Perioperative Neurocognitive Disorders, postoperative delirium, CAM- ICU, ALBA, POBAV, Amnesia Light and Brief Assessment,, screening