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Procedure

REFLECT 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months postoperative

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Probable Benefit

Primary Safety

Secondary outcome measures

Composite endpoint analysis

Curve progression

Device integrity

+2 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Globus Medical IncLead Sponsor

16 Previous Clinical Trials

2,190 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the principal goals that this medical study aims to achieve?

"This research aims to primarily assess safety over a 5-year postoperative period. Secondary measures include device integrity, which encompasses instances of cord breakage and screw migration; composite endpoint analysis, defined as maintaining a major Cobb angle ≤40° while avoiding serious adverse events (SAEs); and SRS score derived from the mean value of the Scoliosis Research Society 22r Patient Questionnaire."

Answered by AI

Are individuals still eligible to apply for participation in this ongoing trial?

"As per the details provided on clinicaltrials.gov, recruitment for this particular research endeavor is presently closed. The trial was initially listed on 3/31/2024 and most recently revised on 3/1/2024. Despite this study not actively enrolling participants currently, it's worth noting that there are 88 alternative clinical trials open to new enrollees at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

REFLECT Scoliosis System Post Approval Study

2024. "REFLECT Scoliosis System Post Approval Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06298812.

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