Change of Intramedullar Pressure After Implantation of Hip Prothesis

January 12, 2020 updated by: Skender Ukaj, University Clinical Centre of Kosova

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kosovo
      • Prishtina, Kosovo, 10000
        • University Clinical Center of Kosovo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
The changes will be measured from the blood taken from operated patients
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
The changes will be measured by the device monitor connected to patient
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
The changes will be measured by the device monitor connected to patient
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
The changes will be measured from the blood taken from operated patients
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
The changes will be measured from the blood taken from operated patients
The blood will be taken from patience 1 hour before and POD1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Clinical Centre of Kosova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2019

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

April 7, 2019

First Submitted That Met QC Criteria

April 24, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 12, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 10/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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