Radiostereometry in Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04960111
• Other study ID #: RSA
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: July 10, 2023

Study information

• Verified date: July 2021
• Source: Istituto Ortopedico Galeazzi
• Contact: Michele Ulivi
• Phone: 00390266214946
• Email: micheleulivi[@]masn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 10, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aseptic Loosening
• Joint Diseases
• Knee Arthropathy
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Galeazzi	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	micro-movement detection with radiostereometry and the patient's perception, measured with Short Form health survey12 at 12 month after surgery.	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	correlation of micromovements and Patient reported outcomes at follow up	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