Arthroplasty ComplicationsNCT03930537
Change of Intramedullar Pressure After Implantation of Hip Prothesis
A study testing Hip replacement in people with Arthroplasty Complications, run by University Clinical Centre of Kosova at 1 site in Kosovo.
Trial summary
It is well known that the changes in intramedullary canal during orthopedic surgeries can cause variuos complication. The change of femoral intramedullary pressure after implantation of hip replacement and its possible complications are not well studied and the investigators are aiming to give more answer to this… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Arthroplasty Complications
- What is being tested?
- Hip replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteKosovo
- Study dates
- 17 Mar 2019to 1 Nov 2019
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient undergoing hip replacement with cemented and non-cemented femoral component
Who cannot join
- ASA IV
- Patient with periprosthetic fractures
- Patient with hip replacement revision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DIfference of Femoral Intramedullar Pressure After Implantation of Cemented Versus Non-cemented Femoral Component of Hip Prothesis
It is well known that the changes in intramedullary canal during orthopedic surgeries can cause variuos complication. The change of femoral intramedullary pressure after implantation of hip replacement and its possible complications are not well studied and the investigators are aiming to give more answer to this issue.
- 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 replacementDevice
The hip replacement surgery is when a damaged hip is replaced with artificial one
| Study group | Role | What they receive |
|---|---|---|
| Hip replacement with cemented femoral component | Active comparator | A special device that measure the pressure will be used to measure the change of pressure before, during and after implantation of cemented femoral component of hip prothesis. Receives: Device: Hip replacement |
| Hip replacement with non-cemented femoral component | Active comparator | A special device that measure the pressure will be used to measure the change of pressure before, during and after implantation of non-cemented femoral component of hip prothesis. Receives: Device: Hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pressure in femoral intramedullary canal after implantation of femoral component
The pressure in intramedullary canal will be measured with customized device
Measured: The femoral intramedullary pressure will be measured before the cut of femoral neck and continuously during first 10 minutes after the implantation of cemented femoral component
Secondary outcomes (6)
Difference of arterial pressure after implantation of femoral component
The changes will be measured by the device monitor connected to patient
Measured: The changes will be measured before implantation and during first 10 minutes after implantation
Difference of changes of Leukocyte formula after implantation of femoral component
The changes will be measured from the blood taken from operated patients
Measured: The blood will be taken from patience 1 hour before and POD1
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 before implantation and during first 10 minutes after implantation
Difference of SpCO after implantation of femoral component
The changes will be measured by the device monitor connected to patient
Measured: The changes will be measured before implantation and during first 10 minutes after implantation
Difference of changes of CRP after implantation of femoral component
The changes will be measured from the blood taken from operated patients
Measured: The blood will be taken from patience 1 hour before and POD1
Difference of changes of Histamine after implantation of femoral component
The changes will be measured from the blood taken from operated patients
Measured: The blood will be taken from patience 1 hour before and POD1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start17 Mar 2019
- Primary completion1 Sep 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
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
- NCT03930537
- Sponsor's protocol ID
- 10/2019
- Status last verified
- Jan 2020
- First submitted
- 7 Apr 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ukaj S, Ukaj D, Dervishaj F, Dyla D, Krasniqi E, Elezi G, Obertinca R, Boshnjaku A. Systemic inflammatory response to cemented and uncemented total hip arthroplasty with PMMA bone cement. Sci Rep. 2025 Nov 20;15(1):40957. doi: 10.1038/s41598-025-24695-0.
PubMed 41266408Ukaj S, Veslko M, Krasniqi S, Podvorica V, Ukaj F, Ahmeti A, Hernigou P, Cimerman M. Cemented stems in healthy elderly patients result in higher hypoxia despite a paradoxical lower femoral increase of intramedullary pressure. Int Orthop. 2021 Apr;45(4):915-922. doi: 10.1007/s00264-021-04955-0. Epub 2021 Feb 2.
PubMed 33528632
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIfference of Femoral Intramedullar Pressure After Implantation of Cemented Versus Non-cemented Femoral Component of Hip Prothesis
- ClinicalTrials.gov ID
- NCT03930537
- Acronym / sponsor ID
- 10/2019
- Conditions
- Arthroplasty Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Clinical Centre of KosovaUniversity, hospital or other
- Study start
- 17 Mar 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 29 Apr 2019 (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.
It is well known that the changes in intramedullary canal during orthopedic surgeries can cause variuos complication. The change of femoral intramedullary pressure after implantation of hip replacement and its possible complications are not well studied and the investigators are aiming to give more answer to this issue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip replacement with cemented femoral component | Active comparator | Device: Hip replacementA special device that measure the pressure will be used to measure the change of pressure before, during and after implantation of cemented femoral component of hip prothesis. |
| Hip replacement with non-cemented femoral component | Active comparator | Device: Hip replacementA special device that measure the pressure will be used to measure the change of pressure before, during and after implantation of non-cemented femoral component of hip prothesis. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patient undergoing hip replacement with cemented and non-cemented femoral component
Key exclusion criteria (3 listed)
- ASA IV
- Patient with periprosthetic fractures
- Patient with hip replacement revision
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 replacementThe hip replacement surgery is when a damaged hip is replaced with artificial one | Device | Hip replacement with cemented femoral component, Hip replacement with non-cemented femoral component |
Primary outcome
Change of pressure in femoral intramedullary canal after implantation of femoral component
Time frame: The femoral intramedullary pressure will be measured before the cut of femoral neck and continuously during first 10 minutes after the implantation of cemented femoral component
The pressure in intramedullary canal will be measured with customized device
6 secondary outcomes
Difference of arterial pressure after implantation of femoral component
Time frame: The changes will be measured before implantation and during first 10 minutes after implantation
Difference of changes of Leukocyte formula after implantation of femoral component
Time frame: The blood will be taken from patience 1 hour before and POD1
Difference of SpO2 after implantation of femoral component
Time frame: The changes will be measured before implantation and during first 10 minutes after implantation
Difference of SpCO after implantation of femoral component
Time frame: The changes will be measured before implantation and during first 10 minutes after implantation
Difference of changes of CRP after implantation of femoral component
Time frame: The blood will be taken from patience 1 hour before and POD1
Difference of changes of Histamine after implantation of femoral component
Time frame: The blood will be taken from patience 1 hour before and POD1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 41266408Ukaj S, Ukaj D, Dervishaj F, Dyla D, Krasniqi E, Elezi G, Obertinca R, Boshnjaku A. Systemic inflammatory response to cemented and uncemented total hip arthroplasty with PMMA bone cement. Sci Rep. 2025 Nov 20;15(1):40957. doi: 10.1038/s41598-025-24695-0.
- Derived from this study: PubMed 33528632Ukaj S, Veslko M, Krasniqi S, Podvorica V, Ukaj F, Ahmeti A, Hernigou P, Cimerman M. Cemented stems in healthy elderly patients result in higher hypoxia despite a paradoxical lower femoral increase of intramedullary pressure. Int Orthop. 2021 Apr;45(4):915-922. doi: 10.1007/s00264-021-04955-0. Epub 2021 Feb 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip replacement in people with 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 14 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pressure in femoral intramedullary canal after implantation of femoral component (time frame: The femoral intramedullary pressure will be measured before the cut of femoral neck and continuously during first 10 minutes after the implantation of cemented femoral component). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03930537, which also lists 2 linked publications.
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 14 Jan 2020.