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

• Conditions: Arthroplasty Complications
• Interventions: Procedure: Hip Replacement

• Registration Number: NCT04913623
• Lead Sponsor: University Clinical Centre of Kosova

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-03-23
• Study First Submitted: 2021-04-05
• Status Verified: 2021-05
• Primary Completion: 2021-05-23
• Study First Submitted QC: 2021-05-30
• Last Update Submitted: 2021-05-30
• Study First Posted: 2021-06-04
• Last Update Posted: 2021-06-04
• Study Completion: 2021-06-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Correlation of intramedullary pressure and systemic inflammatory parameters in non cemented THA	Hip Replacement	-
Correlation of intramedullary pressure and systemic inflammatory parameters in cemented THA	Hip Replacement	-

Primary Outcome Measures

Name	Time	Method
Change of systemic parameters during and after hip replacement (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.	Analysis of the impact of cement in different laboratory parameters such as changes of leukocytes formula
Change of systemic parameters during and after hip replacement (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.	Analysis of the impact of cement in different laboratory parameters such as histamine
Change of systemic parameters during and after hip replacement (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.	Analysis of the impact of cement in different laboratory parameters such as IL6.
Change of systemic parameters during and after hip replacement (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.	Analysis of the impact of cement in different laboratory parameters such as IL1b
Change of systemic parameters during and after hip replacement (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.	Analysis of the impact of cement in different laboratory parameters such as C-reactive protein (CRP)
Change of systemic parameters during and after hip replacement (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.	Analysis of the impact of cement in different laboratory parameters such are TNF alpha

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Clinical Center of Kosovo; Prishtina, Kosovo