Ireland
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Recruiting Not applicable

REFLECT Scoliosis System Post Approval Study

NCT06298812 · tracked via the Priya Life Science USA tracker
Sponsor
Globus Medical Inc
Phase
Not applicable
Started
2024-04-08
Last updated
2026-02-13

Condition(s) studied

Idiopathic Scoliosis

Investigational drug(s) / intervention(s)

REFLECT Scoliosis Correction System

REFLECT Scoliosis Correction System: The REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials.

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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 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 Exclusion Criteria: * Prior spinal surgery at the level(s) to be treated * Documented poor bone quality, defined as a T-score of -1.5 or less * Presence of any systemic infection, local infection, or skin compromise at the surgical site * Any medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions * Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent * Active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present study

Primary outcome measure(s)

  • Primary Probable Benefit — 60 months postoperative
    Maintenance of major Cobb angle less than or equal to 40°
  • Primary Safety — 60 months postoperative
    Serious adverse events (SAEs) and device- or procedure-related adverse events (AEs)

Trial sites (2)

FacilityCityRegionStatus
Mayo Clinic Rochester Minnesota Recruiting
New York University New York New York Enrolling By Invitation

More Globus Medical Inc trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06298812 on ClinicalTrials.gov ↗ ← All trials in the USA