Change of Intramedullar Pressure After Implantation of Hip Prothesis

Arthroplasty Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930537
• Other study ID #: 10/2019
• Status: Completed
• Phase: N/A
• Start date: March 17, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: January 2020
• Source: University Clinical Centre of Kosova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications

Intervention

Device:
• Hip replacement
The hip replacement surgery is when a damaged hip is replaced with artificial one

Locations

Country	Name	City	State
Kosovo	University Clinical Center of Kosovo	Prishtina

Sponsors (1)

Lead Sponsor	Collaborator
University Clinical Centre of Kosova

Country where clinical trial is conducted

Kosovo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of pressure in femoral intramedullary canal after implantation of 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	Difference of arterial pressure after implantation of femoral component	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
Secondary	Difference of changes of Leukocyte formula after implantation of femoral component	The changes will be measured from the blood taken from operated patients	The blood will be taken from patience 1 hour before and POD1
Secondary	Difference of SpO2 after implantation of femoral component	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
Secondary	Difference of SpCO after implantation of femoral component	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
Secondary	Difference of changes of CRP after implantation of femoral component	The changes will be measured from the blood taken from operated patients	The blood will be taken from patience 1 hour before and POD1
Secondary	Difference of changes of Histamine after implantation of femoral component	The changes will be measured from the blood taken from operated patients	The blood will be taken from patience 1 hour before and POD1