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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty Complications
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Skender Ukaj, MD; Phone Number: 0038344603609; Email: skender.ukaj@uni-gjk.org

Study Locations

• Kosovo
  • Prishtina, Kosovo, 10000
    • Recruiting
    • University Clinical Center of Kosovo
    • Contact: Shpend Fazliu; Phone Number: +381 38 500 600; Email: INFO@SHSKUK.ORG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients are from the waiting list for surgery. All are included in the study with their consent The femoral component cemented or non-cemented is realized based on bone quality, age and its testing during surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Correlation of intramedullary pressure and systemic inflammatory parameters in cemented THA	Procedure: Hip Replacement; The hip replacement surgery is when a damaged hip is replaced with artificial one; Other Names: Arthroplasty; Hip replacement surgery
Correlation of intramedullary pressure and systemic inflammatory parameters in non cemented THA	Procedure: Hip Replacement; The hip replacement surgery is when a damaged hip is replaced with artificial one; Other Names: Arthroplasty; Hip replacement surgery

What is the study measuring?

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]

Collaborators and Investigators

• Sponsor: University Clinical Centre of Kosova

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Actual): May 23, 2021
• Study Completion (Anticipated): June 23, 2021

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: May 30, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 30, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 03/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No