Change of Intramedullar Pressure After Implantation of Hip Prothesis

Not Applicable

Completed

• Conditions: Arthroplasty Complications
• Interventions: Device: Hip replacement

• Registration Number: NCT03930537
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-17
• Study First Submitted: 2019-04-07
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-29
• Primary Completion: 2019-09-01
• Study Completion: 2019-11-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-12
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hip replacement with cemented femoral component	Hip replacement	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.
Hip replacement with non-cemented femoral component	Hip replacement	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.

Primary Outcome Measures

Name	Time	Method
Change of pressure in femoral intramedullary canal after implantation of femoral component	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

Name	Time	Method
Difference of arterial pressure after implantation of femoral component	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
Difference of changes of Leukocyte formula after implantation of femoral component	The blood will be taken from patience 1 hour before and POD1	The changes will be measured from the blood taken from operated patients
Difference of changes of Histamine after implantation of femoral component	The blood will be taken from patience 1 hour before and POD1	The changes will be measured from the blood taken from operated patients
Difference of SpCO after implantation of femoral component	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
Difference of changes of CRP after implantation of femoral component	The blood will be taken from patience 1 hour before and POD1	The changes will be measured from the blood taken from operated patients
Difference of SpO2 after implantation of femoral component	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

Trial Locations

Locations (1)

University Clinical Center of Kosovo; Prishtina, Kosovo