NCT07184073

Brief Summary

this study aimed to investigate the association between cognitive fraility and selected plasma and cerebrospinal fluid biomarkers related to neurodegenetaion and neuroinflammation in older adult patients undergoing elective orthopedic surgery. The main questions it aims to answer is:

  • Can biomarkers indicating neurodegeneration and neuroinflammation be correlated with preoperative frailty and cognitive functions?
  • Can these biomarkers be used as potential tools for early identification in vulnarable populations?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2022

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

September 13, 2025

Last Update Submit

September 13, 2025

Conditions

Keywords

cognitive frailtyneurofilament light chaincerebrospinal fluid biomarkersolder adult patientsorthopedic surgery

Outcome Measures

Primary Outcomes (1)

  • Correlation between biomarkers of neurodegeneration and preoperative frailty, cognitive function?

    p\<0,05 was accepted as statistically significant

    preoperatively and four weeks postoperatively

Study Arms (1)

age 65-74

Behavioral: assessment Mini mental state examinationBehavioral: assessment FRAIL scaleOther: collecting cerebrospinal fluid during regional anesthesia

Interventions

pre operatively four weeks postoperatively

age 65-74

pre operatively four weeks postoperatively

age 65-74

In the operating room regional anesthesia was administered according to the surgical plan

age 65-74

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

patients aged 65 years or older who underwent elective major lower extremity orthopedic surgery under regional anesthesia

You may qualify if:

  • ASA 1-3 patients
  • \>65 age patients

You may not qualify if:

  • history of psychiatric or neurological disease
  • uncontrolled hypertension
  • alchohol dependence
  • renal failure
  • active liver disease
  • cancer-related or emergency surgery
  • unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Ankara Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Fang J, Liang H, Chen M, Zhao Y, Wei L. Association of preoperative cognitive frailty with postoperative complications in older patients under general anesthesia: a prospective cohort study. BMC Geriatr. 2024 Oct 19;24(1):851. doi: 10.1186/s12877-024-05431-1.

    PMID: 39427111BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

samples of cerebrospinal fluid

MeSH Terms

Conditions

Cognitive DysfunctionCharcot-Marie-Tooth disease, Type 1F

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr

Study Record Dates

First Submitted

September 13, 2025

First Posted

September 19, 2025

Study Start

June 3, 2021

Primary Completion

September 4, 2022

Study Completion

September 4, 2022

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations