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

Arthroplasty Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04913623
• Other study ID #: 03/2021
• Status: Recruiting
• Start date: March 23, 2021
• Est. completion date: June 23, 2021

Study information

• Verified date: May 2021
• Source: University Clinical Centre of Kosova
• Contact: Skender Ukaj, MD
• Phone: 0038344603609
• Email: skender.ukaj[@]uni-gjk.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 23, 2021
• Est. primary completion date: May 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications

Intervention

Procedure:
• Hip Replacement
The hip replacement surgery is when a damaged hip is replaced with artificial one

Locations

Country	Name	City	State
Kosovo	University Clinical Center of Kosovo	Prishtina

Sponsors (1)

Lead Sponsor	Collaborator
University Clinical Centre of Kosova

Country where clinical trial is conducted

Kosovo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	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
Secondary	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]