REFLECT Scoliosis Correction System Post-Approval Registry

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Enhanced Recovery After Surgery for Adolescent Idiopathic Scoliosis Surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.