Change of Intramedullar Pressure After Implantation of Hip Prothesis

Study Overview
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Brief Summary
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It is well known that the changes in intramedullary canal during orthopedic surgeries can cause variuos complication. The change of femoral intramedullary pressure after implantation of hip replacement and its possible complications are not well studied and the investigators are aiming to give more answer to this issue.

Official Title
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DIfference of Femoral Intramedullar Pressure After Implantation of Cemented Versus Non-cemented Femoral Component of Hip Prothesis

Conditions
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Arthroplasty Complications

Intervention / Treatment
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* Device: Hip replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient undergoing hip replacement with cemented and non-cemented femoral component Exclusion Criteria: ASA IV Patient with periprosthetic fractures Patient with hip replacement revision

Ages Eligible for Study
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Minimum Age: 65 Years

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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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hip replacement with cemented femoral component<br>A special device that measure the pressure will be used to measure the change of pressure before, during and after implantation of cemented femoral component of hip prothesis. | Device: Hip replacement<br>* The hip replacement surgery is when a damaged hip is replaced with artificial one<br>|
| Active Comparator: Hip replacement with non-cemented femoral component<br>A special device that measure the pressure will be used to measure the change of pressure before, during and after implantation of non-cemented femoral component of hip prothesis. | Device: Hip replacement<br>* The hip replacement surgery is when a damaged hip is replaced with artificial one<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pressure in femoral intramedullary canal after implantation of femoral component | The pressure in intramedullary canal will be measured with customized device | The femoral intramedullary pressure will be measured before the cut of femoral neck and continuously during first 10 minutes after the implantation of cemented femoral component | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of arterial pressure after implantation of femoral component | The changes will be measured by the device monitor connected to patient | The changes will be measured before implantation and during first 10 minutes after implantation | 
| Difference of changes of Leukocyte formula after implantation of femoral component | The changes will be measured from the blood taken from operated patients | The blood will be taken from patience 1 hour before and POD1 | 
| 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 before implantation and during first 10 minutes after implantation | 
| Difference of SpCO after implantation of femoral component | The changes will be measured by the device monitor connected to patient | The changes will be measured before implantation and during first 10 minutes after implantation | 
| Difference of changes of CRP after implantation of femoral component | The changes will be measured from the blood taken from operated patients | The blood will be taken from patience 1 hour before and POD1 | 
| Difference of changes of Histamine after implantation of femoral component | The changes will be measured from the blood taken from operated patients | The blood will be taken from patience 1 hour before and POD1 |