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REFLECT Scoliosis System Post Approval Study
Sponsor: Globus Medical Inc
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
Official title: A Prospective, Single-Arm, Multi-Center, Registry Post-Approval Study of Growth Modulation in the Treatment of Idiopathic Scoliosis With the REFLECT™ Scoliosis Correction System
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-04-08
Completion Date
2032-03-31
Last Updated
2026-02-13
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (2)
Mayo Clinic
Rochester, Minnesota, United States
New York University
New York, New York, United States