Recruiting

REFLECT™ Scoliosis

Sponsor:

Globus Medical Inc

Code:

NCT06298812

Conditions

Idiopathic Scoliosis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

REFLECT Scoliosis Correction System

Study Details

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

Study ID

NCT06298812

Start date

Apr 8, 2024

Status verified date

Feb, 2026

Completion date

Mar 31, 2032

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: REFLECT

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

Interventions

REFLECT Scoliosis Correction System

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.

Primary outcome measure

  • Primary Probable Benefit [ Time Frame: 60 months postoperative ]
  • Primary Safety [ Time Frame: 60 months postoperative ]

Central Contacts and Locations

Central contacts

Rebecca Smith

858-922-7112rsmith@globusmedical.com

Shannon Bahn

sbahn@globusmedical.com

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Noelle Larson, MD

More Information

Sponsor

Globus Medical Inc

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Globus Medical Inc on 2026-02-13.