REFLECT System for Idiopathic Scoliosis

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Globus Medical Inc

No Placebo Group

Trial Summary

What is the purpose of 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

Research Team

Eligibility Criteria

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.

Inclusion Criteria

My condition is worsening scoliosis without a known cause.

Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging

Failed or intolerant to bracing

Exclusion Criteria

I do not have any infections or skin issues at the surgery area.

Documented poor bone quality, defined as a T-score of -1.5 or less

I have had spinal surgery at the same spot that needs treatment now.

Treatment Details

Interventions

• REFLECT Scoliosis Correction System (Procedure)

Trial Overview 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.

Participant Groups

Group I: REFLECT Experimental Treatment 1 Intervention

Enrolled patients are treated with the REFLECT Scoliosis System. This is an HDE-approved device.

Who Is Running the Clinical Trial?

Globus Medical Inc

Lead Sponsor

Trials

17

Recruited

2,300+