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|
| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P050050 S024/ PAS001 |
| Date Original Protocol Accepted |
03/13/2024
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| Date Current Protocol Accepted |
|
| Study Name |
S.T.A.R. Ankle PAS
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| Device Name |
Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle)
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Study Objective: Demonstrate equal or better performance of the STAR TAR system with vitamin E (e+) mobile bearing relative to a historical control with respect to cumulative revision rate at 8 years post implantation.
Study Design: Prospective, Multicenter, Single-Arm, Comparative Observational Study
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| Study Population |
The study population includes adult subjects (aged 22 years and over) implanted with the STAR TAR System with the e+ mobile bearing for the treatment of painful arthritic ankle joints due to osteoarthritis, posttraumatic arthritis, or rheumatoid arthritis.
The comparator is a historical control group consisting of a cumulative revision rate for all fixed bearing ankles from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) at eight (8) years post-implantation.
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| Sample Size |
Number of Patients: 300 evaluable patients
Assumptions: The sample size is determined using a precision – based method assuming a revision rate of 4.5% for the STAR TAR system with e+ mobile bearing at 7 years follow-up, a 95% confidence interval with an upper confidence limit of 6.8%, and a type 1 error of 5%. To account for a 20% attrition rate, at least 375 patients will be enrolled in this study.
Number of Sites: 8 – 10 US Sites
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| Key Study Endpoints |
Primary Endpoints:
• Device cumulative revision rate of the STAR TAR system with e+ mobile bearing at eight (8) years post-implantation.
• Within the primary endpoint, a quantitative assessment of the polyethylene fracture rate of the subject device to the historical control data will be performed
Secondary Endpoints:
• Device revision rate assessed at all timepoints post-implantation
• Change from baseline for Total Buechel-Pappas Scale Score
• Change from baseline for Pain Visual Analog Scale (VAS) (100mm scale)
• Change from baseline for Quality of Life (SF-36)
• Change from baseline for American Orthopedic Foot & Ankle Society (AOFAS) Ankle Hindfoot Scale Score
• Radiographic endpoints (anterior-posterior and lateral x-ray images of the treated ankle)
o Quantitative and qualitative radiographic assessment of the total ankle arthroplasty including evaluation of both the femoral and tibial components, for the following outcomes:
. radiolucency and osteolysis
. subsidence
. migration
. rotation
. integrity.
. Assessment of polyethylene bearing for integrity (e.g., fracture, dislocation, subluxation, worn, intact).
• Explant analysis of any explanted devices and all revisions
• All adverse events including the nature, onset, duration, severity, and relationship to the device and/or procedure
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| Follow-up Visits and Length of Follow-up |
8 years
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