NCT03930537

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

April 7, 2019

Last Update Submit

January 12, 2020

Conditions

Arthroplasty Complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Difference of arterial pressure after implantation of femoral component

    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

    The blood will be taken from patience 1 hour before and POD1

  • Difference of SpO2 after implantation of femoral component

    The changes will be measured before implantation and during first 10 minutes after implantation

  • Difference of SpCO after implantation of femoral component

    The changes will be measured before implantation and during first 10 minutes after implantation

  • Difference of changes of CRP after implantation of femoral component

    The blood will be taken from patience 1 hour before and POD1

  • +1 more secondary outcomes

Study Arms (2)

Hip replacement with cemented femoral component

ACTIVE COMPARATOR

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

Hip replacement with non-cemented femoral component

ACTIVE COMPARATOR

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

Interventions

Hip replacementDEVICE

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

Hip replacement with cemented femoral componentHip replacement with non-cemented femoral component

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient undergoing hip replacement with cemented and non-cemented femoral component

You may not qualify if:

  • ASA IV
  • Patient with periprosthetic fractures
  • Patient with hip replacement revision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Center of Kosovo

Pristina, 10000, Kosovo

Location

Related Publications (2)

  • Ukaj S, Ukaj D, Dervishaj F, Dyla D, Krasniqi E, Elezi G, Obertinca R, Boshnjaku A. Systemic inflammatory response to cemented and uncemented total hip arthroplasty with PMMA bone cement. Sci Rep. 2025 Nov 20;15(1):40957. doi: 10.1038/s41598-025-24695-0.

    PMID: 41266408DERIVED

  • Ukaj S, Veslko M, Krasniqi S, Podvorica V, Ukaj F, Ahmeti A, Hernigou P, Cimerman M. Cemented stems in healthy elderly patients result in higher hypoxia despite a paradoxical lower femoral increase of intramedullary pressure. Int Orthop. 2021 Apr;45(4):915-922. doi: 10.1007/s00264-021-04955-0. Epub 2021 Feb 2.

    PMID: 33528632DERIVED

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of Orthopaedics and Trauma

Study Record Dates

First Submitted

April 7, 2019

First Posted

April 29, 2019

Study Start

March 17, 2019

Primary Completion

September 1, 2019

Study Completion

November 1, 2019

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

KO(1)