Back to resultsRadiostereometry in Knee Arthroplasty
Primary Purpose
Knee Osteoarthritis, Knee Arthropathy, Aseptic Loosening
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
RSA
Sponsored by
About this trial
This is an interventional prevention trial for Knee Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- Istituto Ortopedico GaleazziRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
knee arthroplasty with radiostereometry tecnique
Arm Description
patient underwent total knee arthroplasty with insertion of microsphere in tantallium for radiostereometry tecnique.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04960111
First Posted
July 2, 2021
Last Updated
July 13, 2021
Sponsor
Istituto Ortopedico Galeazzi
1. Study Identification
Unique Protocol Identification Number
NCT04960111
Brief Title
Radiostereometry in Knee Arthroplasty
Official Title
Radiostereometry (Model Based RSA) in the Assessment of Knee Prosthesis Outcome:a Prospective,Pilot,Single-center Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 10, 2022 (Anticipated)
Study Completion Date
July 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Arthropathy, Aseptic Loosening
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
knee arthroplasty with radiostereometry tecnique
Arm Type
Experimental
Arm Description
patient underwent total knee arthroplasty with insertion of microsphere in tantallium for radiostereometry tecnique.
Intervention Type
Device
Intervention Name(s)
RSA
Intervention Description
application of tantalium microsphere around knee prosthesis and RSA X-ray post operative to detect early mobilization in follow up.
Primary Outcome Measure Information:
Title
micro-movement detection with radiostereometry and the patient's perception, measured with Short Form health survey12 at 12 month after surgery.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
correlation of micromovements and Patient reported outcomes at follow up
Description
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
Time Frame
baseline to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Ulivi
Phone
00390266214946
Email
micheleulivi@masn.com
Facility Information:
Facility Name
Istituto Ortopedico Galeazzi
City
Milano
ZIP/Postal Code
20161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
michele ulivi, Dr
Phone
00390266214946
Email
micheleulivi@msn.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Radiostereometry in Knee Arthroplasty
We'll reach out to this number within 24 hrs