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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04913623
Enrollment
60
Registered
2021-06-04
Start date
2021-03-23
Completion date
2021-06-23
Last updated
2021-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Complications

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.

Interventions

PROCEDUREHip Replacement

The hip replacement surgery is when a damaged hip is replaced with artificial one

Sponsors

University Clinical Centre of Kosova
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 (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 (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 (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
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 (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)

Secondary

MeasureTime frameDescription
Difference of changes of Leukocyte formulaThe blood will be taken from patience 1 hour before and Post Operative Day OneDifference of changes of Leukocyte formula after implantation of femoral component
Difference of SpO2The 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 arterial pressureThe changes will be measured 5 minutes before implantation and during first 10 minutes after implantationDifference of arterial pressure after implantation of femoral component

Countries

Kosovo

Contacts

Primary ContactSkender Ukaj, MD
skender.ukaj@uni-gjk.org0038344603609

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026