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

A Retrospective Review of Clinical and Radiographic Outcomes Following the Use of the REFLECT™ Scoliosis Correction System in the Treatment of Idiopathic Scoliosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Scoliosis
• Intervention / Treatment: Device: Scoliosis Correction System; Device: Scoliosis Correction System

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Rebecca Smith; Phone Number: 858-922-7112; Email: rsmith@globusmedical.com
• Study Contact Backup: Name: Shannon Bahn; Email: sbahn@globusmedical.com

Study Locations

• Germany
  • Simmerath
    • Simmerath, Simmerath, Germany, 52152
      • Eifel Clinic St. Brigida GmbH & Co. KG
      • Contact: Mahmoud Alkharsawi, MD; Phone Number: +41 02473 89-2325; Email: m.alkharsawi@gmail.com
      • Principal Investigator: Per Trobisch, MD
• Turkey (Türkiye)
  • I
    • Istanbul, I, Turkey (Türkiye), 34457
      • Acibadem Maslak Hospital
      • Principal Investigator: Ahmet Alanay, MD
      • Contact: Tais Zulemyan; Phone Number: +90 212 304 36 36; Email: tais.zulemyan@gmail.com
• United States
  • New York
    • New York, New York, United States, 11554
      • NYU Langone Orthopedic Center
      • Contact: Korine Pagulayan; Phone Number: 516-324-7500; Email: korine.pagulayan@nyulangone.org
      • Principal Investigator: Juan C Rodriguez-Olaverri, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of skeletally immature pediatric and adolescent patients with progressive idiopathic scoliosis who were treated surgically with the REFLECT™ Scoliosis Correction System as part of routine clinical care. Eligible patients had a major spinal curve between 30° and 65°, required surgical correction after failing or being unable to tolerate bracing, and had adequate bone quality to support screw fixation.

This is a multicenter, international retrospective cohort including approximately 100 patients treated at participating institutions in Germany, Turkey, and the United States. The cohort includes patients treated with either 4.0 mm or 5.0 mm REFLECT cords, using single or dual cords per curve, with at least 12 months of postoperative clinical and radiographic follow-up available for review.

Description

Inclusion Criteria:

Subjects must meet all of the following criteria to be included in the study:

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

Exclusion Criteria:

Patients were excluded from the study if they met any of the following conditions:

1. Presence of any systemic infection, local infection, or skin compromise at the surgical site
2. Prior spinal surgery at the level(s) to be treated
3. Known poor bone quality, defined as a T-score of -1.5 or less
4. 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
4.0 Group; 4.0 mm diameter REFLECT cords were used to treat patients.	Device: Scoliosis Correction System; The REFLECT system is a non-fusion spinal device, meaning it corrects scoliosis without permanently fusing the spine. Instead of rigid metal rods, it uses a flexible polymer cord attached to screws. For this intervention, a 4.0 mm cord diameter was used to treat patients.; Device: Scoliosis Correction System; The REFLECT system is a non-fusion spinal device, meaning it corrects scoliosis without permanently fusing the spine. Instead of rigid metal rods, it uses a flexible polymer cord attached to screws. For this intervention, a 5.0 mm cord diameter was used to treat patients.
5.0 Group; 5.0 mm diameter REFLECT cords were used to treat patients.	Device: Scoliosis Correction System; The REFLECT system is a non-fusion spinal device, meaning it corrects scoliosis without permanently fusing the spine. Instead of rigid metal rods, it uses a flexible polymer cord attached to screws. For this intervention, a 4.0 mm cord diameter was used to treat patients.; Device: Scoliosis Correction System; The REFLECT system is a non-fusion spinal device, meaning it corrects scoliosis without permanently fusing the spine. Instead of rigid metal rods, it uses a flexible polymer cord attached to screws. For this intervention, a 5.0 mm cord diameter was used to treat patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
REFLECT Cord Breakage/Separation	Comparison of REFLECT cord breakage/separation rate (radiographically suspected or confirmed) in 4.0 mm vs. 5.0 mm cords	by latest available time point (minimum 12 months postoperative)
Subsequent Surgeries Related to Cord Breakage	Rate of subsequent surgeries at the treatment levels associated with REFLECT cord breakage/separation	by latest available time point (minimum 12 months postoperative)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications Profile	Rate of all complications attributable to the REFLECT system	up to the latest available follow-up visit, with a required minimum of 12 months after surgery.
All Subsequent Surgeries	Rate of all subsequent surgeries at the treatment levels that are associated with the REFLECT system	up to the latest available follow-up visit, with a required minimum of 12 months after surgery.
Change in Curve	Change in curve(s), as measured by the change in Cobb angle(s)	From baseline (preoperative) to each postoperative time point.

Collaborators and Investigators

• Sponsor: Globus Medical Inc

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: scoliosis; idiopathic scoliosis; spinal curve; REFLECT System
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: GMED.REF0325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes