REFLECT Scoliosis System Post Approval Study

NCT06298812 | Recruiting DMC FDA Device

• 1 other identifier: GMED.REF0723
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Conditions

Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (2)

• Primary Probable Benefit

  Maintenance of major Cobb angle less than or equal to 40°

  60 months postoperative

• Primary Safety

  Serious adverse events (SAEs) and device- or procedure-related adverse events (AEs)

  60 months postoperative

Secondary Outcomes (5)

• Curve progression

  60 months postoperative

• Device integrity

  60 months postoperative

• Composite endpoint analysis

  60 months postoperative

• Failure analysis

  60 months postoperative

• SRS score

  60 months postoperative

Study Arms (1)

REFLECT

OTHER

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

Device: REFLECT Scoliosis Correction System

Interventions

REFLECT Scoliosis Correction System DEVICE

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 segments in a more natural anatomic position using non-rigid materials.

REFLECT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Globus Medical Inc: lead

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

New York University

New York, New York, 10016, United States

ENROLLING BY INVITATION

Central Study Contacts

Rebecca Smith

CONTACT

858-922-7112; rsmith@globusmedical.com

Shannon Bahn

CONTACT

sbahn@globusmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients treated with the REFLECT Scoliosis Correction System

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: April 8, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2032
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)