Radiostereometry in Knee Arthroplasty

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

Status: Unknown

Conditions: Aseptic Loosening; Knee Osteoarthritis; Knee Arthropathy

Treatments: Device: RSA

Study type: Interventional

Funder types: Other

Identifiers

NCT04960111

RSA

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

knee arthroplasty with radiostereometry tecnique

Experimental group

Description:

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

Treatment:

Device: RSA