Radiostereometry in Knee Arthroplasty

Not Applicable

• Conditions: Aseptic Loosening; Knee Osteoarthritis; Knee Arthropathy
• Interventions: Device: RSA

• Registration Number: NCT04960111
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-10
• Status Verified: 2021-07
• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-02
• Study First Posted: 2021-07-13
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-19
• Primary Completion: 2022-12-10
• Study Completion: 2023-07-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
knee arthroplasty with radiostereometry tecnique	RSA	patient underwent total knee arthroplasty with insertion of microsphere in tantallium for radiostereometry tecnique.

Primary Outcome Measures

Name	Time	Method
micro-movement detection with radiostereometry and the patient's perception, measured with Short Form health survey12 at 12 month after surgery.	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.

Secondary Outcome Measures

Name	Time	Method
correlation of micromovements and Patient reported outcomes at follow up	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

Trial Locations

Locations (1)

Istituto Ortopedico Galeazzi; 🇮🇹 Milano, Italy