|
|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P050050 / PAS002 |
| Date Original Protocol Accepted |
05/27/2009
|
| Date Current Protocol Accepted |
05/06/2022
|
| Study Name |
Actual Conditions of Use Study (STAR 2)
|
| Device Name |
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a retrospective, Real-World Evidence multi-center study.
The purpose of this study is to examine the safety and survivorship of the STAR™ Ankle under actual conditions of use, employing the approved instructions for use, labeling, and instrumentation.
This study will enroll a minimum of 500 on-label subjects across approximately 5 sites in the United States, consecutively implanted per site, who are to be assessed in this clinical investigation. Each site will have a minimum of fifty patients, with subject patient primary surgery dates taking place between 2015-2019.
|
| Study Population |
A minimum of 500 adult male or female subjects, who meet all the study criteria (listed in 4.6), that received treatment with the STAR ankle implant for ankle replacement for treatment of a painful arthritic ankle joint due to osteoarthritis, posttraumatic arthritis or rheumatoid arthritis. Patients sets at each site will be on-label and consecutive.
The study plan is to enroll all on-label, consecutive patients per site with primary STAR surgery dates between 2015 and 2019. With this surgery date range, the potential patient follow-up period should be between approximately two years at a minimum to seven years maximum. With this new patient follow-up range, the longer time periods for this subject study will be between the PAS2 and PAS8 study bounds.
|
| Sample Size |
No. of subjects: 500 on-label subjects
No. of sites: 5 (Each site will have a minimum of 50 patients).
Sites location: US
|
| Key Study Endpoints |
Primary Objective:
To examine the safety and survivorship of the STAR™ Ankle under actual conditions of use, employing the approved instructions for use, labeling, and instrumentation. The primary endpoint consists of evaluating key safety and survivorship parameters associated with the STAR™ Ankle, with specific elements listed below.
1. Reoperations - incidence rates and times to event will be collected.
2. Revisions - incidence rates and times to event will be collected.
3. Removals - Incidence rates and times to event will be collected.
4. Occurrence and types of serious device-related adverse events.
Secondary Objective:
Information regarding the following patient and treatment parameters will be gathered and assessed in the course of evaluation:
Nature/reason for revision, onset, duration, severity, relationship to the device, relationship to the operative procedure, and outcome of any adverse event
|
| Follow-up Visits and Length of Follow-up |
Duration of follow-up will vary based upon date of primary STAR surgery. All available patient records through the present will be collected per patient, such that patients with surgery dates in 2015 may have up to seven years of follow-up, while those patients with surgery dates in 2019 may have approximately two years of follow-up.
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
66 adverse events were reported.
AEs were associated with 20 of the 46 patients, representing an average of 3.3 AEs per patient with AEs.
Five (5) reoperations, three (3) revisions, and zero (0) removals were recorded in the current 46-patient data set.
|
| Actual Number of Patients Enrolled |
46
|
| Actual Number of Sites Enrolled |
8
|
| Patient Follow-up Rate |
9%
|
