Radiostereometry in Knee Arthroplasty
Radiostereometry (Model Based RSA) in the Assessment of Knee Prosthesis Outcome:a Prospective,Pilot,Single-center Study.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable knee-osteoarthritis
Started Dec 2019
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2019
CompletedFirst Submitted
Initial submission to the registry
July 2, 2021
CompletedFirst Posted
Study publicly available on registry
July 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2023
CompletedJuly 19, 2021
July 1, 2021
3 years
July 2, 2021
July 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
correlation of micromovements and Patient reported outcomes at follow up
baseline to 24 months
Study Arms (1)
knee arthroplasty with radiostereometry tecnique
EXPERIMENTALpatient underwent total knee arthroplasty with insertion of microsphere in tantallium for radiostereometry tecnique.
Interventions
application of tantalium microsphere around knee prosthesis and RSA X-ray post operative to detect early mobilization in follow up.
Eligibility Criteria
You may qualify if:
- age more than 18
- patients underwent total knee arthroplasty without controindications for this procedure
- patients enrolled in PatientsReportedOutcomesMeasureS (PROMS) study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto Ortopedico Galeazzi
Milan, 20161, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2021
First Posted
July 13, 2021
Study Start
December 10, 2019
Primary Completion
December 10, 2022
Study Completion
July 10, 2023
Last Updated
July 19, 2021
Record last verified: 2021-07