Not Yet RecruitingNot Applicable

A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis

United States, Germany, Turkey (Türkiye)100 participantsStarted 2026-06-15

Plain-language summary

This study reviews medical records of children and adolescents treated for idiopathic scoliosis (a sideways curve of the spine with no known cause) using the REFLECT™ Scoliosis Correction System.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Requires surgical treatment to obtain and maintain correction of idiopathic scoliosis
. Skeletally immature
. Major Cobb angle of 30° and 65°
. Bone structure adequate to safely accommodate screw fixation
. Failed bracing treatment and/or intolerant to brace wear
. Treated with the REFLECT™ Scoliosis Correction System, using single or dual REFLECT cord(s) per curve
. Availability of medical and radiographic records evaluating the product under study preoperatively through a minimum of 12 months postoperative

Exclusion criteria

. Presence of any systemic infection, local infection, or skin compromise at the surgical site
. Prior spinal surgery at the level(s) to be treated
. Known poor bone quality, defined as a T-score of -1.5 or less
. Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, or patient unwillingness or inability to cooperate with postoperative care instructions

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

REFLECT Cord Breakage/Separation

Timeframe: by latest available time point (minimum 12 months postoperative)

Subsequent Surgeries Related to Cord Breakage

Timeframe: by latest available time point (minimum 12 months postoperative)

Trial details

NCT IDNCT07589023

SponsorGlobus Medical Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-01-30

Contact for this trial

Rebecca Smith

858-922-7112 rsmith@globusmedical.com

View on ClinicalTrials.gov More Idiopathic Scoliosis trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Requires surgical treatment to obtain and maintain correction of idiopathic scoliosis
. Skeletally immature
. Major Cobb angle of 30° and 65°
. Bone structure adequate to safely accommodate screw fixation
. Failed bracing treatment and/or intolerant to brace wear
. Treated with the REFLECT™ Scoliosis Correction System, using single or dual REFLECT cord(s) per curve
. Availability of medical and radiographic records evaluating the product under study preoperatively through a minimum of 12 months postoperative

Exclusion criteria

. Presence of any systemic infection, local infection, or skin compromise at the surgical site
. Prior spinal surgery at the level(s) to be treated
. Known poor bone quality, defined as a T-score of -1.5 or less
. Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, or patient unwillingness or inability to cooperate with postoperative care instructions