NCT06298812 REFLECT Scoliosis System Post Approval Study
| NCT ID | NCT06298812 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Globus Medical Inc |
| Condition | Idiopathic Scoliosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-08 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-04-08 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06298812 clinical trial?
This trial is open to participants of all sexes, studying Idiopathic Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06298812 currently recruiting?
Yes, NCT06298812 is actively recruiting participants. Contact the research team at rsmith@globusmedical.com for enrollment information.
Where is the NCT06298812 trial being conducted?
This trial is being conducted at Rochester, United States, New York, United States.
Who is sponsoring the NCT06298812 clinical trial?
NCT06298812 is sponsored by Globus Medical Inc. The trial plans to enroll 100 participants.