REFLECT System for Idiopathic Scoliosis

Overseen By Jacqueline Myer, BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Globus Medical Inc

Disqualifiers: Prior spinal surgery, Poor bone quality, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the REFLECT Scoliosis Correction System to evaluate its effectiveness for individuals with idiopathic scoliosis, a condition where the spine curves sideways. The goal is to gather information on the device's impact on spine alignment and overall health. Suitable candidates have scoliosis that continues to worsen, with a curve between 30° and 65°, and have not found success with bracing. The study focuses on those with flexible spines who have not undergone prior spinal surgery. Participants will use this device to determine if it can improve their condition effectively and safely. As an unphased trial, this study allows patients to contribute to innovative research that could lead to new treatment options.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the REFLECT Scoliosis Correction System is safe for treating idiopathic scoliosis?

Research has shown that the REFLECT™ Scoliosis Correction System is safe for its intended use. A clinical study collected data to assess the risks of using this device. As a non-fusion spinal device, the REFLECT System corrects scoliosis without hindering natural spine growth.

The REFLECT System received approval under the Humanitarian Device Exemption (HDE) category. This approval indicates that it treats certain conditions based on available evidence of safety and likely benefits. When used as directed, the device is generally well-tolerated.

Although no medical treatment is entirely risk-free, the REFLECT System's safety profile led to its approval. Discussing any concerns with a healthcare provider is crucial to understanding what this means for a specific situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The REFLECT Scoliosis Correction System is unique because it offers a different approach compared to traditional treatments like bracing or spinal fusion surgery for idiopathic scoliosis. This system is an HDE-approved device designed to correct spinal curvature without the need for invasive surgery. Researchers are excited because it could provide a less invasive, potentially safer alternative that allows for more flexibility and growth in young patients. This could mean fewer complications and a better quality of life for those affected by scoliosis.

What evidence suggests that the REFLECT Scoliosis Correction System is effective for idiopathic scoliosis?

Research has shown that the REFLECT Scoliosis Correction System, which participants in this trial will receive, is designed to help straighten the spine while allowing for continued growth and movement. This system aims to effectively correct the curve in patients with scoliosis. Many patients have reported positive outcomes, indicating that they often experience good results with this device. The system has approval under a Humanitarian Device Exemption (HDE), meaning it is considered safe and potentially helpful for this condition. Overall, the REFLECT System offers a promising treatment option for those with idiopathic scoliosis. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for 100 patients with idiopathic scoliosis. Specific details about who can join are not provided, but typically participants would have a diagnosis of scoliosis and meet certain health standards set by the study.

Inclusion Criteria

My condition is worsening scoliosis without a known cause.

My spine curve is between 30° and 65°.

My spine bends less than 30 degrees to the side.

Exclusion Criteria

I do not have any infections or skin issues at the surgery area.

Documented poor bone quality, defined as a T-score of -1.5 or less

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Preoperative evaluations and preparations for surgery

1-2 weeks

1 visit (in-person)

Intraoperative

Surgical treatment with the REFLECT Scoliosis Correction System

1 day

1 visit (in-person)

Immediate Postoperative

Initial recovery and assessment after surgery

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Visits at 6 weeks, 6 months, 12 months, 24 months, and 60 months

What Are the Treatments Tested in This Trial?

Interventions

• REFLECT Scoliosis Correction System

Trial Overview The REFLECT Scoliosis Correction System is being evaluated in this study. It's a single-arm registry Post-Approval Study (PAS) to assess radiographic and clinical outcomes in patients treated with this system after it has been approved.

How Is the Trial Designed?

Group I: REFLECT Experimental Treatment 1 Intervention

Enrolled patients are treated with the REFLECT Scoliosis System. This is an HDE-approved device.

Who Is Running the Clinical Trial?

Globus Medical Inc

Lead Sponsor

Trials

17

Recruited

2,300+

Published Research Related to This Trial

In a 10-week study involving 164 patients undergoing elective orthopedic procedures, independent clinical reviewers identified significantly more adverse events (99) compared to surgeons (14), highlighting a gap in surgeons' reporting practices.

While surgeons effectively captured major adverse events, they missed many minor events that were documented by reviewers, suggesting that using standardized assessment tools like SAVES V2 and OrthoSAVES could enhance overall adverse-event reporting in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES? Chen, BP., Garland, K., Roffey, DM., et al.[2018]

In a study of 466 patients with adolescent idiopathic scoliosis, the reoperation rates after spinal deformity surgery varied by technique, ranging from 4.5% for open anterior spinal fusion to 8.8% for posterior spinal fusion with hooks, indicating that while reoperations are necessary, they occur at relatively low rates.

The study identified common serious radiographic adverse events, such as rod breakage and proximal screw pullout, but found no significant differences in the incidence of these events across different surgical techniques, suggesting that all methods have similar safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic classification of complications of instrumentation in adolescent idiopathic scoliosis. Flynn, JM., Betz, RR., O'Brien, MF., et al.[2021]

Citations

1. fda.gov fda.gov/media/187207/download?attachment

REFLECT (H210002) 2025 PAC Executive Summary These patient-reported outcomes were considered as part of the benefit-risk assessment for the subject device, and as noted above, were generally positive in.

2. trials.arthritis.org trials.arthritis.org/trials/NCT06298812

REFLECT Scoliosis System Post Approval Study The REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06521814?cond=tethering%20scoliosis&viewType=Table&rank=3

Study Details | NCT06521814 | Globus Reflect Tether - HUD The Globus Reflect scoliosis correction system aims to provide curve correction for scoliosis patients who are still actively growing. Surgical correction is ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2200711/

Results of brace treatment of adolescent idiopathic ... The overall results of brace treatment of idiopathic scoliosis in male patients were inferior compared with matched females. One reason for inferior overall ...

5. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?t_id=742687&c_id=7418

Post-Approval Studies (PAS) Database - accessdata.fda.gov The purpose of this multi-center, prospective, single-arm registry study is to evaluate radiographic and clinical outcomes of patients with idiopathic scoliosis ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/H210002B.pdf

SUMMARY OF SAFETY AND PROBABLE BENEFIT (SSPB) Safety Conclusions. The risks of the REFLECT™ Scoliosis Correction System are based on data collected in a clinical study that was used to ...

7. globusmedical.com globusmedical.com/wp-content/uploads/2023/08/DI196A_REFLECT_ProductInsert_revA.pdf

DI196A REFLECT™ Scoliosis Correction System when used in accordance with the indications for use. This device can be considered safe for its intended use, based ...