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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Change of Intramedullar Pressure After Implantation of Hip Prothesis

Clinicaltrials.gov identifier NCT03930537

Recruitment Status Completed

First Posted April 29, 2019

Last update posted January 14, 2020

Study Description

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:Arthroplasty Complications
  • Intervention/Treatment: Device: Hip replacement
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Actual Primary Completion Date: September 2019
  • Actual Study Completion Date: November 2019
Arms and interventions
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
Outcome Measures
  • 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
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

Kosovo
University Clinical Center of Kosovo
Prishtina

Sponsors and Collaborators

University Clinical Centre of Kosova

More Information
  • Responsible Party: 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: January 14, 2020
  • Last Verified: January 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No