Arthroplasty ComplicationsNCT04913623
Correlation of Intramedullary Pressure and Systemic Inflammatory Parameters in Cemented Femoral Stem
An observational study of Arthroplasty Complications, run by University Clinical Centre of Kosova at 1 site in Kosovo.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty Complications
- What is being tested?
- Hip Replacement
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteKosovo
- Study dates
- 23 Mar 2021to 23 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- The inclusion criteria were as follows:
- All patients willing to participate who underwent cemented and uncemented THA,
- With no limit on age
Who cannot join
- The exclusion criteria were patients with:
- Periprosthetic fractures,
- Pathological fractures
- THA revision
- ASA IV
Trial locations and contacts
1 site in 1 country.
Kosovo1 site, 1 recruiting
- Recruiting
University Clinical Center of Kosovo
Pristina, 10000
Shpend Fazliu, +381 38 500 600, INFO@SHSKUK.ORG
About this study
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
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.
Read the 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.
- Conditions
- Arthroplasty Complications
- Being tested
- Hip Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip ReplacementProcedure or surgery
Also called Hip replacement surgery, Arthroplasty
The hip replacement surgery is when a damaged hip is replaced with artificial one
| Study group | Role | What they receive |
|---|---|---|
| Correlation of intramedullary pressure and systemic inflammatory parameters in cemented THA | Not described Receives: Procedure: Hip Replacement | |
| Correlation of intramedullary pressure and systemic inflammatory parameters in non cemented THA | Not described Receives: Procedure: Hip Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of systemic parameters during and after hip replacement (Histamine)
Analysis of the impact of cement in different laboratory parameters such as histamine
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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 (3)
Difference of arterial pressure
Difference of arterial pressure after implantation of femoral component
Measured: 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
Measured: 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
Measured: The changes will be measured 5 minutes before implantation and during first 10 minutes after implantation]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start23 Mar 2021
- Primary completion23 May 2021
- Study completion23 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinical Centre of Kosova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Skender Ukaj, University Clinical Centre of Kosova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913623
- Sponsor's protocol ID
- 03/2021
- Status last verified
- May 2021
- First submitted
- 5 Apr 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04913623
- Acronym / sponsor ID
- 03/2021
- Conditions
- Arthroplasty Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Clinical Centre of KosovaUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 23 May 2021 (actual)
- Study completion
- 23 Jun 2021 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Correlation of intramedullary pressure and systemic inflammatory parameters in cemented THA | – | Procedure: Hip Replacement |
| Correlation of intramedullary pressure and systemic inflammatory parameters in non cemented THA | – | Procedure: Hip Replacement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- All patients willing to participate who underwent cemented and uncemented THA,
- With no limit on age
Key exclusion criteria (5 listed)
- Periprosthetic fractures,
- Pathological fractures
- THA revision
- ASA IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip ReplacementAlso: Hip replacement surgery, ArthroplastyThe hip replacement surgery is when a damaged hip is replaced with artificial one | Procedure or surgery | Correlation of intramedullary pressure and systemic inflammatory parameters in cemented THA, Correlation of intramedullary pressure and systemic inflammatory parameters in non cemented THA |
Primary outcome
Change of systemic parameters during and after hip replacement (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.
Analysis of the impact of cement in different laboratory parameters such as histamine
Change of systemic parameters during and after hip replacement (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.
Analysis of the impact of cement in different laboratory parameters such as C-reactive protein (CRP)
Change of systemic parameters during and after hip replacement (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.
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)
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.
Analysis of the impact of cement in different laboratory parameters such as IL1b
Change of systemic parameters during and after hip replacement (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.
Analysis of the impact of cement in different laboratory parameters such are TNF alpha
Change of systemic parameters during and after hip replacement (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.
Analysis of the impact of cement in different laboratory parameters such as IL6.
3 secondary outcomes
Difference of arterial pressure
Time frame: The changes will be measured 5 minutes before implantation and during first 10 minutes after implantation
Difference of changes of Leukocyte formula
Time frame: The blood will be taken from patience 1 hour before and Post Operative Day One
Difference of SpO2
Time frame: The changes will be measured 5 minutes before implantation and during first 10 minutes after implantation]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty Complications, run by University Clinical Centre of Kosova at 1 site in Kosovo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kosovo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Skender Ukaj, MD (0038344603609, skender.ukaj@uni-gjk.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of systemic parameters during and after hip replacement (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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.