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

Study Overview
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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.

Official Title
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Correlation of Intramedullary Pressure and Systemic Inflammatory Parameters as a Risk Indicator for Intraoperative and Early Postoperative Complications in Cemented and Non-cemented Femoral Stem of the Hip Arthroplasty

Conditions
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Arthroplasty Complications

Intervention / Treatment
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* Procedure: Hip Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria were as follows: All patients willing to participate who underwent cemented and uncemented THA, With no limit on age Exclusion Criteria: The exclusion criteria were patients with: Periprosthetic fractures, Pathological fractures THA revision ASA IV
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Correlation of intramedullary pressure and systemic inflammatory parameters in cemented THA<br> | Procedure: Hip Replacement<br>* The hip replacement surgery is when a damaged hip is replaced with artificial one<br>* Other names: Arthroplasty;|
| Correlation of intramedullary pressure and systemic inflammatory parameters in non cemented THA<br> | Procedure: Hip Replacement<br>* The hip replacement surgery is when a damaged hip is replaced with artificial one<br>* Other names: Arthroplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of systemic parameters during and after hip replacement (Histamine) | Analysis of the impact of cement in different laboratory parameters such as histamine | The measurement of these laboratory parameters 5 minutes before and 10 minutes after surgical procedures will reflect the impact of cements in the eventual post-surgical complications, such are embolism and other complications. | 
| Change of systemic parameters during and after hip replacement (CRP) | Analysis of the impact of cement in different laboratory parameters such as C-reactive protein (CRP) | The measurement of these laboratory parameters 5 minutes before and 10 minutes after surgical procedures will reflect the impact of cements in the eventual post-surgical complications, such are embolism and other complications. | 
| Change of systemic parameters during and after hip replacement (Leukocytes formula) | Analysis of the impact of cement in different laboratory parameters such as changes of leukocytes formula | The measurement of these laboratory parameters 5 minutes before and 10 minutes after surgical procedures will reflect the impact of cements in the eventual post-surgical complications, such are embolism and other complications. | 
| Change of systemic parameters during and after hip replacement (IL1b) | Analysis of the impact of cement in different laboratory parameters such as IL1b | The measurement of these laboratory parameters 5 minutes before and 10 minutes after surgical procedures will reflect the impact of cements in the eventual post-surgical complications, such are embolism and other complications. | 
| Change of systemic parameters during and after hip replacement (TNF alpha) | Analysis of the impact of cement in different laboratory parameters such are TNF alpha | The measurement of these laboratory parameters 5 minutes before and 10 minutes after surgical procedures will reflect the impact of cements in the eventual post-surgical complications, such are embolism and other complications. | 
| Change of systemic parameters during and after hip replacement (IL6) | Analysis of the impact of cement in different laboratory parameters such as IL6. | The measurement of these laboratory parameters 5 minutes before and 10 minutes after surgical procedures will reflect the impact of cements in the eventual post-surgical complications, such are embolism and other complications. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of arterial pressure | Difference of arterial pressure after implantation of femoral component | The changes will be measured 5 minutes before implantation and during first 10 minutes after implantation | 
| Difference of changes of Leukocyte formula | Difference of changes of Leukocyte formula after implantation of femoral component | The blood will be taken from patience 1 hour before and Post Operative Day One | 
| Difference of SpO2 | Difference of SpO2 after implantation of femoral component The changes will be measured by the device monitor connected to patient | The changes will be measured 5 minutes before implantation and during first 10 minutes after implantation] |