Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-03-25 @ 8:24 PM
Study NCT ID:
NCT06298812
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2024-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REFLECT Scoliosis System Post Approval Study
Sponsor:
Globus Medical Inc
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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. REFLECT™ uses a growth modulation technique in which growth of the patient is used to achieve progressive scoliosis correction.
The REFLECT™ Scoliosis Correction System is indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, who have a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or are intolerant to brace wear.
A total of 100 patients will be prospectively enrolled and treated at a minimum of 5 U.S. sites, with a maximum of 20 subjects at any one site, with sequential enrollment from each site. Patients will be followed for 5 years with evaluations at the following timepoints: preoperative, intraoperative, immediate postoperative (first erect), 6 weeks, 6 months, 12 months, 24 months, and 60 months. Primary and secondary outcomes from 100 patients enrolled and treated with REFLECT™ will be summarized.
The REFLECT™ Scoliosis Correction System is indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, who have a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or are intolerant to brace wear.
A total of 100 patients will be prospectively enrolled and treated at a minimum of 5 U.S. sites, with a maximum of 20 subjects at any one site, with sequential enrollment from each site. Patients will be followed for 5 years with evaluations at the following timepoints: preoperative, intraoperative, immediate postoperative (first erect), 6 weeks, 6 months, 12 months, 24 months, and 60 months. Primary and secondary outcomes from 100 patients enrolled and treated with REFLECT™ will be summarized.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: