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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Diagnosis of progressive idiopathic scoliosis
• Preoperative major Cobb angle 30°-65°
• Preoperative flexibility to ≤30° on side bending radiograph (left or right)
• Skeletally immature at the time of surgery with Risser sign \<5 or Sanders score \<8
• Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
• Failed or intolerant to bracing
• Signed informed consent and/or assent forms specific to this study
Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Contact Information
Primary
Rebecca Smith
rsmith@globusmedical.com
858-922-7112
Backup
Shannon Bahn
sbahn@globusmedical.com
Time Frame
Start Date: 2024-04-08
Estimated Completion Date: 2032-03-31
Participants
Target number of participants: 100
Treatments
Other: REFLECT
Enrolled patients are treated with the REFLECT Scoliosis System. This is an HDE-approved device.
Related Therapeutic Areas
Sponsors
Leads: Globus Medical Inc