Change of Intramedullar Pressure After Implantation of Hip Prothesis

NCT ID: NCT03930537

Last Updated: 2020-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-17

Study Completion Date

2019-11-01

Brief Summary

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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

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Conditions

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Arthroplasty Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Hip replacement

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Hip replacement

Intervention Type DEVICE

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

Interventions

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Hip replacement

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Clinical Centre of Kosova

OTHER

Sponsor Role lead

Responsible Party

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Skender Ukaj

Specialist of Orthopaedics and Trauma

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Clinical Center of Kosovo

Pristina, , Kosovo

Site Status

Countries

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Kosovo

References

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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.

Reference Type DERIVED
PMID: 33528632 (View on PubMed)

Other Identifiers

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10/2019

Identifier Type: -

Identifier Source: org_study_id

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