ClinicalTrials.gg
CompletedNCT03930537Updated Jan 14, 2020

Change of Intramedullar Pressure After Implantation of Hip Prothesis

An interventional study of Hip replacement in Arthroplasty Complications, sponsored by University Clinical Centre of Kosova. Completed at 1 site in Kosovo. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-01-14.

Sponsored by University Clinical Centre of Kosova · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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 issue.

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Conditions studied

  • Arthroplasty Complications
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In context

Lead sponsor

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.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Patient undergoing hip replacement with cemented and non-cemented femoral component

Exclusion criteria

Exclusion Criteria:

  • Patient with periprosthetic fractures
  • Patient with hip replacement revision
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Hip replacement with cemented femoral component

    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.

    Device: Hip replacement

  • Active comparator
    Hip replacement with non-cemented femoral component

    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.

    Device: Hip replacement

Interventions

  • DeviceHip replacement

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

06

What researchers measure

Primary outcomes

  1. Change of pressure in femoral intramedullary canal after implantation of femoral component

    The pressure in intramedullary canal will be measured with customized device

    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

Secondary outcomes

  1. Difference of arterial pressure after implantation of femoral component

    The changes will be measured by the device monitor connected to patient

    Time frame: The changes will be measured before implantation and during first 10 minutes after implantation

  2. Difference of changes of Leukocyte formula after implantation of femoral component

    The changes will be measured from the blood taken from operated patients

    Time frame: The blood will be taken from patience 1 hour before and POD1

  3. 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 before implantation and during first 10 minutes after implantation

  4. Difference of SpCO after implantation of femoral component

    The changes will be measured by the device monitor connected to patient

    Time frame: The changes will be measured before implantation and during first 10 minutes after implantation

  5. Difference of changes of CRP after implantation of femoral component

    The changes will be measured from the blood taken from operated patients

    Time frame: The blood will be taken from patience 1 hour before and POD1

  6. Difference of changes of Histamine after implantation of femoral component

    The changes will be measured from the blood taken from operated patients

    Time frame: The blood will be taken from patience 1 hour before and POD1

07

Study locations

1 site
  • University Clinical Center of Kosovo
    Prishtina, 10000, Kosovo
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References and documents

Publications

  • Ukaj 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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2019 to primary completion in Sep 2019, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2019
First posted
Apr 29, 2019
StartActual
Mar 17, 2019
Primary completionActual
Sep 1, 2019
CompletionActual
Nov 1, 2019
Last update
Jan 14, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03930537
Lead sponsor
University Clinical Centre of Kosova
Responsible party
Skender Ukaj (Specialist of Orthopaedics and Trauma, University Clinical Centre of Kosova) — Principal investigator
First posted
Apr 29, 2019
Start date
Mar 17, 2019
Primary completion
Sep 1, 2019
Completion
Nov 1, 2019
Last update
Jan 14, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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