An observational study in Arthroplasty Complications, sponsored by University Clinical Centre of Kosova. Status unknown at 1 site in Kosovo. Per ClinicalTrials.gov, last updated 2021-06-04.
Sponsored by University Clinical Centre of Kosova · Observational
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.
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.
University Clinical Centre of Kosova is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The inclusion criteria were as follows:
Exclusion Criteria:
The exclusion criteria were patients with:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Hip Replacement
Procedure: Hip Replacement
The hip replacement surgery is when a damaged hip is replaced with artificial one
Also known as: Hip replacement surgery, Arthroplasty
Change of systemic parameters during and after hip replacement (Histamine)
Analysis of the impact of cement in different laboratory parameters such as histamine
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Difference of arterial pressure
Difference of arterial pressure after implantation of femoral component
Time frame: 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
Time frame: 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
Time frame: The changes will be measured 5 minutes before implantation and during first 10 minutes after implantation]
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2021 to primary completion in May 2021, 2 months.
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This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University Clinical Centre of Kosova