REFLECT Scoliosis System Post Approval Study

Recruiting now · Not applicable

Conditions studied: Idiopathic Scoliosis

In brief

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

Key facts

Study ID

NCT06298812

Run by

Globus Medical Inc

People needed

100

Starts

2024-04-08

Expected to finish

2032-03-31

Last updated by the study team

2026-02-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• New York University — New York, New York, United States

Full record on ClinicalTrials.gov

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