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Cerebral Regional Oxygen Saturation and Markers of Brain Damage During Primary Hip Arthroplasty

M

Military Institute od Medicine National Research Institute

Status

Completed

Conditions

Arthroplasty, Hip Replacement
Delirium, Dementia, Amnestic, Cognitive Disorders

Treatments

Device: cemented or cementless type of hip prothesis

Study type

Interventional

Funder types

Other

Identifiers

NCT02342236
06101968-3

Details and patient eligibility

About

Postoperative Cognitive Disorders (POCD) are common in hospitalized people > 60 year old, especially in orthopedic patients. Etiology of POCD is complex, and in some aspects still remains unclear. The role of thromboembolic events in etiology of POCD was discussed. The incidence of such events in patients who underwent big joints arthroplasty can be as high as 40 to 60%, although some cases are subclinical. Thromboembolic material can block a blood flow through a vessels in the brain. As a consequence cerebral neurons can be damaged or destroyed. After neuronal damage specific substances, such as S100B protein, glial fibrillary acidic protein (GFAP) and neuron-specific enolase (NSE) are released to the blood. The serum concentrations of these biomarkers can be measured. Moreover, the block of blood flow will decrease regional cerebral saturation in affected parts of the brain.

In this project the authors would like to analyze the correlation between the regional cerebral saturation and serum concentration of both S100B protein and GFAP in orthopedic patients scheduled to primary hip arthroplasty.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patient scheduled to primary hip arthroplasty,
  • orthopedic procedure under spinal anesthesia.

Exclusion criteria

  • patients younger than 18 y.o.,
  • surgery under general anesthesia,
  • patients who refused to participate in the study.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

18 participants in 2 patient groups

cemented
Other group
Description:
Primary hip arthroplasty with bone cement use.
Treatment:
Device: cemented or cementless type of hip prothesis
cementless
Other group
Description:
Primary hip arthroplasty without bone cement use.
Treatment:
Device: cemented or cementless type of hip prothesis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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