Radiostereometry in Knee Arthroplasty

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04960111

Enrollment

Registered

2021-07-13

Start date

2019-12-10

Completion date

2023-07-10

Last updated

2021-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aseptic Loosening, Knee Arthropathy, Knee Osteoarthritis

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.

Interventions

DEVICERSA

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactMichele Ulivi

micheleulivi@masn.com00390266214946

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026