Correlation of Intramedullary Pressure and Systemic Inflammatory Parameters in Cemented Femoral Stem

NCT ID: NCT04913623

Last Updated: 2021-06-04

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

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-23

Study Completion Date

2021-06-23

Brief Summary

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The cemented femoral stem have impact on increase on systemic parameters.

Evaluation of the level of histamine, C-reactive protein (CRP) and leukocytes formula, IL1b, TNF alpha, IL6 and the reflection of changes of these parameters in the intra-operative course of hip replacement.

Detailed Description

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Implantation of total endoprosthesis is a very common surgical procedure and is performed with and without bone cement.

In most cases during cementation of the femoral component there are changes in blood pressure, SpO2, heartbeat and other vital parameters which can cause complications during surgery.

Comparing the system parameters between the two groups and deriving these results will help the medical staff to be more professionally prepared to resolve possible complications.

Conditions

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Arthroplasty Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Correlation of intramedullary pressure and systemic inflammatory parameters in cemented THA

Hip Replacement

Intervention Type PROCEDURE

The hip replacement surgery is when a damaged hip is replaced with artificial one

Correlation of intramedullary pressure and systemic inflammatory parameters in non cemented THA

Hip Replacement

Intervention Type PROCEDURE

The hip replacement surgery is when a damaged hip is replaced with artificial one

Interventions

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Hip Replacement

The hip replacement surgery is when a damaged hip is replaced with artificial one

Intervention Type PROCEDURE

Other Intervention Names

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Hip replacement surgery Arthroplasty

Eligibility Criteria

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Inclusion Criteria

* All patients willing to participate who underwent cemented and uncemented THA,
* With no limit on age

Exclusion Criteria

* Periprosthetic fractures,
* Pathological fractures
* THA revision
* ASA IV
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Clinical Centre of Kosova

OTHER

Sponsor Role lead

Responsible Party

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Skender Ukaj

Specialist of Orthopaedics and Trauma

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Clinical Center of Kosovo

Pristina, , Kosovo

Site Status RECRUITING

Countries

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Kosovo

Central Contacts

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Skender Ukaj, MD

Role: CONTACT

0038344603609

Facility Contacts

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Shpend Fazliu

Role: primary

+381 38 500 600

Other Identifiers

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03/2021

Identifier Type: -

Identifier Source: org_study_id

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