Clinical trial NCT04913623: Correlation of Intramedullary Pressure and Systemic Inflammatory Parameters in Cemented Femoral Stem
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthroplasty Complications
Lead sponsor: University Clinical Centre of Kosova
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of systemic parameters during and after hip replacement (Histamine)
timeFrame: 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.
measure: Change of systemic parameters during and after hip replacement (CRP)
timeFrame: 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.
measure: Change of systemic parameters during and after hip replacement (Leukocytes formula)
timeFrame: 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.
measure: Change of systemic parameters during and after hip replacement (IL1b)
timeFrame: 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.
measure: Change of systemic parameters during and after hip replacement (TNF alpha)
timeFrame: 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.
measure: Change of systemic parameters during and after hip replacement (IL6)
timeFrame: 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 outcomes:
measure: Difference of arterial pressure
timeFrame: The changes will be measured 5 minutes before implantation and during first 10 minutes after implantation
measure: Difference of changes of Leukocyte formula
timeFrame: The blood will be taken from patience 1 hour before and Post Operative Day One
measure: Difference of SpO2
timeFrame: The changes will be measured 5 minutes before implantation and during first 10 minutes after implantation]
Other outcomes:
Locations:
city: Prishtina
country: Kosovo
facility: University Clinical Center of Kosovo
Study officials:
References: