REFLECT Scoliosis Correction System Post-Approval Registry
A Prospective, Single-Arm, Multi-Center, Registry Post-Approval Study of Growth Modulation in the Treatment of Idiopathic Scoliosis With the REFLECT™ Scoliosis Correction System
This project will try the REFLECT Scoliosis Correction System in 100 skeletally immature patients with progressive idiopathic scoliosis (Cobb 30–65°) to see if it improves spine curvature and function over five years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Globus Medical Inc Industry-sponsored |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Trial ID | NCT06298812 on ClinicalTrials.gov |
What this trial studies
The REFLECT Post‑Approval Registry is a prospective, single‑arm, multi‑center effort enrolling 100 skeletally immature patients with progressive idiopathic scoliosis who have failed or are intolerant of bracing. All participants will receive the REFLECT Scoliosis Correction System, a non‑rigid growth‑modulation implant designed to hold spinal segments in a more anatomic position while permitting continued growth and mobility. Patients will be followed at preoperative, immediate postoperative, 6 weeks, 6 months, 12 months, 24 months and 60 months with radiographic measures and clinical outcomes collected at each timepoint. Primary and secondary outcomes from the cohort will be summarized to satisfy post‑approval monitoring requirements.
Who should consider this trial
Good fit: Ideal candidates are skeletally immature patients with progressive idiopathic scoliosis, a major Cobb angle of 30–65°, side‑bending flexibility ≤30°, who have failed or are intolerant of bracing and have bone anatomy suitable for screw fixation.
Not a fit: Patients with prior spinal surgery at the levels to be treated, poor bone quality, active infection, non‑idiopathic scoliosis, skeletal maturity, or inability/unwillingness to follow postoperative care are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, the device could provide a surgical option that gradually corrects scoliosis while preserving spinal growth and motion, potentially reducing the need for spinal fusion.
How similar studies have performed: Similar growth‑modulation approaches such as vertebral body tethering have shown promising early results, but long‑term comparative data are still limited.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Rochester, Minnesota and 1 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- New York University — New York, New York, United States (Enrolling_by_invitation)
Study contacts
- Study coordinator: Rebecca Smith
- Email: rsmith@globusmedical.com
- Phone: 858-922-7112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.