NCT06298812

REFLECT Scoliosis System Post Approval Study

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Globus Medical Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Scoliosis

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-04-08
• Primary completion: 2027-03-31
• Completion: 2032-03-31
• First posted: 2024-03-07
• Last updated: 2026-02-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study