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Change of Intramedullar Pressure After Implantation of Hip Prothesis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03930537
Enrollment
60
Registered
2019-04-29
Start date
2019-03-17
Completion date
2019-11-01
Last updated
2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Complications

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.

Interventions

DEVICEHip replacement

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

Sponsors

University Clinical Centre of Kosova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of pressure in femoral intramedullary canal after implantation of femoral componentThe femoral intramedullary pressure will be measured before the cut of femoral neck and continuously during first 10 minutes after the implantation of cemented femoral componentThe pressure in intramedullary canal will be measured with customized device

Secondary

MeasureTime frameDescription
Difference of changes of Leukocyte formula after implantation of femoral componentThe blood will be taken from patience 1 hour before and POD1The changes will be measured from the blood taken from operated patients
Difference of SpO2 after implantation of femoral componentThe changes will be measured before implantation and during first 10 minutes after implantationThe changes will be measured by the device monitor connected to patient
Difference of arterial pressure after implantation of femoral componentThe changes will be measured before implantation and during first 10 minutes after implantationThe changes will be measured by the device monitor connected to patient
Difference of changes of CRP after implantation of femoral componentThe blood will be taken from patience 1 hour before and POD1The changes will be measured from the blood taken from operated patients
Difference of changes of Histamine after implantation of femoral componentThe blood will be taken from patience 1 hour before and POD1The changes will be measured from the blood taken from operated patients
Difference of SpCO after implantation of femoral componentThe changes will be measured before implantation and during first 10 minutes after implantationThe changes will be measured by the device monitor connected to patient

Countries

Kosovo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026