Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298812
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-03-01
Brief Title:
REFLECT Scoliosis System Post Approval Study
Sponsor:
Globus Medical Inc
Organization:
Globus Medical Inc
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 andor are intolerant to brace wear
A total of 100 patients will be prospectively enrolled and treated at a minimum of 5 US 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 andor are intolerant to brace wear
A total of 100 patients will be prospectively enrolled and treated at a minimum of 5 US 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:
None
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?:
None