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Change of Intramedullar Pressure After Implantation of Hip Prothesis

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ClinicalTrials.gov Identifier: NCT03930537
Recruitment Status : Active, not recruiting
First Posted : April 29, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Skender Ukaj, University Clinical Centre of Kosova

Brief 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.

Condition or disease Intervention/treatment Phase
Arthroplasty Complications Device: Hip replacement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: DIfference of Femoral Intramedullar Pressure After Implantation of Cemented Versus Non-cemented Femoral Component of Hip Prothesis
Actual Study Start Date : March 17, 2019
Actual Primary Completion Date : September 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
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
The hip replacement surgery is when a damaged hip is replaced with artificial one

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930537


Locations
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Kosovo
University Clinical Center of Kosovo
Prishtina, Kosovo, 10000
Sponsors and Collaborators
University Clinical Centre of Kosova

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Responsible Party: Skender Ukaj, Specialist of Orthopaedics and Trauma, University Clinical Centre of Kosova
ClinicalTrials.gov Identifier: NCT03930537     History of Changes
Other Study ID Numbers: 10/2019
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No