|
General |
Study Status |
Delayed |
Application Number / Requirement Number |
H190005 / PAS001 |
Date Original Protocol Accepted |
01/13/2020
|
Date Current Protocol Accepted |
06/10/2025
|
Study Name |
The Tether Vertebral Tethering System PAS
|
Device Name |
The Tether™ - Vertebral Body Tethering System
|
Clinical Trial Number(s) |
NCT02897453
|
General Study Protocol Parameters |
Study Design |
Prospective & Retrospective Study
|
Data Source |
Sponsor Registry
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs
|
Detailed Study Protocol Parameters |
Study Objectives |
The objective is to assess the ongoing safety and probable benefit of The Tether in a registry population.The study design is a single-arm, prospective, multicenter cohort, registry study.
|
Study Population |
The study population is comprised of skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis who receive the device in the post market environment. There is no comparator group.
|
Sample Size |
At least 193 patients will be enrolled.
|
Key Study Endpoints |
The primary probable benefit endpoint is the percentage of patients with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery. The primary safety endpoints are serious adverse events (SAEs), and device- or procedure-related AEs.
|
Follow-up Visits and Length of Follow-up |
Patients will be followed through 60-months from the time of each patient's index surgery.
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
Across 9 sites, 89 patients were actively enrolled. However, two MSH patients were removed due to data quality issues, such as late or missing data, missed protocol visits, and non-compliance with the protocol. Thus, the current number of subjects actively enrolled is 87.
|
Actual Number of Sites Enrolled |
9 active sites
|
Patient Follow-up Rate |
Two patients at the MSH site were excluded from the study due to the discontinuation of the MSH site. The sponsor noted data quality issues such as late data and missed protocol visits.
|