Actively Recruiting
REFLECT Scoliosis System Post Approval Study
Led by Globus Medical Inc · Updated on 2026-02-13
100
Participants Needed
2
Research Sites
416 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
REFLECT Scoliosis System Post Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of progressive idiopathic scoliosis
- Preoperative major Cobb angle 30656
- Preoperative flexibility to 306 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
New York University
New York, New York, United States, 10016
Enrolling by Invitation
Research Team
R
Rebecca Smith
CONTACT
S
Shannon Bahn
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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