Radiostereometry in Knee Arthroplasty

July 13, 2021 updated by: Istituto Ortopedico Galeazzi

Radiostereometry (Model Based RSA) in the Assessment of Knee Prosthesis Outcome:a Prospective,Pilot,Single-center Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milano, Italy, 20161
        • Recruiting
        • Istituto Ortopedico Galeazzi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: knee arthroplasty with radiostereometry tecnique
patient underwent total knee arthroplasty with insertion of microsphere in tantallium for radiostereometry tecnique.
Device: RSA
application of tantalium microsphere around knee prosthesis and RSA X-ray post operative to detect early mobilization in follow up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
micro-movement detection with radiostereometry and the patient's perception, measured with Short Form health survey12 at 12 month after surgery.
Time Frame: 12 months
evaluate correlation between levels of micro-movement of the prosthetic components using radiostereometry model based RSA and the patient's perception, measured with Short Form health survey12 at 12 month after surgery.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of micromovements and Patient reported outcomes at follow up
Time Frame: baseline to 24 months
evaluate correlation between levels of micro-movement of the prosthetic components using radiostereometry model based RSA and the patient's perception, measured with patient reported oucomes used in Galeazzi Institute Registry at each post operative follow-up
baseline to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Anticipated)

December 10, 2022

Study Completion (Anticipated)

July 10, 2023

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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