REFLECT Scoliosis System Post Approval Study
Condition(s) studied
Investigational drug(s) / intervention(s)
REFLECT Scoliosis Correction System: The REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials.
Study summary
The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval
Eligibility
Primary outcome measure(s)
- Primary Probable Benefit — 60 months postoperative
Maintenance of major Cobb angle less than or equal to 40° - Primary Safety — 60 months postoperative
Serious adverse events (SAEs) and device- or procedure-related adverse events (AEs)
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| New York University | New York | New York | Enrolling By Invitation |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06298812 on ClinicalTrials.gov ↗ ← All trials in the USA