REFLECT Scoliosis System for Idiopathic Scoliosis

REFLECT Scoliosis System Post Approval Study

Recruiting N/A Interventional Study
Idiopathic Scoliosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Globus Medical Inc · Industry
Who this trial is looking for

This trial is looking for patients with idiopathic scoliosis who need treatment. Participants will be treated with the REFLECT™ Scoliosis Correction System and will be monitored for their outcomes.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with progressive idiopathic scoliosis
  • My major Cobb angle is between 30° and 65°
  • My spine can bend to a maximum of 30°
  • I am skeletally immature and have a Risser sign less than 5
  • I cannot wear a brace successfully
  • I can provide signed consent for this study

You may not be able to join if

  • I have had spinal surgery at the levels to be treated
  • My bone quality is poor as defined by a T-score of -1.5 or less
  • I have a current infection or wound at the surgery site
  • I have a medical condition that would make surgery unsafe
  • I cannot return for follow-up visits as required by the study
  • I am currently in another high-risk drug or device study

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

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

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 dimens…
Contacts

Rebecca Smith

858-922-7112

rsmith@globusmedical.com

CONTACT

Shannon Bahn

sbahn@globusmedical.com

CONTACT