Radiostereometry in Knee Arthroplasty

NCT ID: NCT04960111

Last Updated: 2021-07-19

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2023-07-10

Brief Summary

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The innovative aspect of this research is the possibility of combining the data collected with radiostereometric model based Radiostereometry with the data collected through the Galeazzi Institute Registry.This opens the prospect of an earlier identification of patients undergoing prosthetic knee replacement with initial aseptic loosening.

Detailed Description

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Conditions

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Knee Osteoarthritis Knee Arthropathy Aseptic Loosening

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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knee arthroplasty with radiostereometry tecnique

patient underwent total knee arthroplasty with insertion of microsphere in tantallium for radiostereometry tecnique.

Group Type EXPERIMENTAL

RSA

Intervention Type DEVICE

application of tantalium microsphere around knee prosthesis and RSA X-ray post operative to detect early mobilization in follow up.

Interventions

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RSA

application of tantalium microsphere around knee prosthesis and RSA X-ray post operative to detect early mobilization in follow up.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age more than 18
* patients underwent total knee arthroplasty without controindications for this procedure
* patients enrolled in PatientsReportedOutcomesMeasureS (PROMS) study

Exclusion Criteria

* age less than 18
* comorbility that make difficult come back for follow-up
* patients with allergy at materials used in Radiostereometry tecnique
* infection
* anemia, obesity, osteoporosis
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Michele Ulivi

Role: CONTACT

00390266214946

Facility Contacts

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michele ulivi, Dr

Role: primary

00390266214946

Other Identifiers

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RSA

Identifier Type: -

Identifier Source: org_study_id

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