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Completed

NCT Number: NCT03930537

Change of Intramedullar Pressure After Implantation 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.

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Key information

Conditions

Arthroplasty Complications

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinical Center of Kosovo

Pristina, 10000, Kosovo

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • ASA IV
  • Patient with periprosthetic fractures
  • Patient with hip replacement revision

Treatment and study plan

Hip replacement

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

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

  2. 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

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

  3. Difference of SpO2 after implantation of femoral component

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

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

  4. Difference of SpCO after implantation of femoral component

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

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

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

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

University Clinical Centre of Kosova

Other

Registry information

Official study title

DIfference of Femoral Intramedullar Pressure After Implantation of Cemented Versus Non-cemented Femoral Component of Hip Prothesis

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2019
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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