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NCT Number: NCT07589023

A Retrospective Review: Outcomes of the REFLECT™ System for 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Eifel Clinic St. Brigida GmbH & Co. KG, Simmerath, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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

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

  • 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

Treatment and study plan

Scoliosis Correction System

Device

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.

Primary outcomes

  1. REFLECT Cord Breakage/Separation

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

    Comparison of REFLECT cord breakage/separation rate (radiographically suspected or confirmed) in 4.0 mm vs. 5.0 mm cords

  2. Subsequent Surgeries Related to Cord Breakage

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

    Rate of subsequent surgeries at the treatment levels associated with REFLECT cord breakage/separation

Secondary outcomes

  1. Complications Profile

    Time frame: up to the latest available follow-up visit, with a required minimum of 12 months after surgery.

    Rate of all complications attributable to the REFLECT system

  2. All Subsequent Surgeries

    Time frame: up to the latest available follow-up visit, with a required minimum of 12 months after surgery.

    Rate of all subsequent surgeries at the treatment levels that are associated with the REFLECT system

  3. Change in Curve

    Time frame: From baseline (preoperative) to each postoperative time point.

    Change in curve(s), as measured by the change in Cobb angle(s)

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Smith

CONTACT

[email protected]

858-922-7112

Shannon Bahn

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Globus Medical Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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