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Procedure

REFLECT System for Idiopathic Scoliosis

N/A
Waitlist Available
Research Sponsored by Globus Medical Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months postoperative
Awards & highlights
No Placebo-Only Group

Summary

This trial will follow 100 patients with idiopathic scoliosis who are treated with the REFLECT™ Scoliosis Correction System to see how well it works and how patients do after treatment.

Who is the study for?
This trial is for 100 patients with idiopathic scoliosis. Specific details about who can join are not provided, but typically participants would have a diagnosis of scoliosis and meet certain health standards set by the study.
What is being tested?
The REFLECT Scoliosis Correction System is being evaluated in this study. It's a single-arm registry Post-Approval Study (PAS) to assess radiographic and clinical outcomes in patients treated with this system after it has been approved.
What are the potential side effects?
Side effects are not detailed here, but generally, scoliosis correction systems may cause pain at the site of surgery, infection risk, nerve damage, or hardware-related complications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Probable Benefit
Primary Safety
Secondary study objectives
Composite endpoint analysis
Curve progression
Device integrity
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: REFLECTExperimental Treatment1 Intervention
Enrolled patients are treated with the REFLECT Scoliosis System. This is an HDE-approved device.

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Who is running the clinical trial?

Globus Medical IncLead Sponsor
16 Previous Clinical Trials
2,190 Total Patients Enrolled
~67 spots leftby Mar 2027
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