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

Part of paid clinical trials in New York, New York.

Sponsor
Globus Medical Inc
Study ID
NCT07589023
Status
Not Yet Recruiting

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Conditions

  • Idiopathic Scoliosis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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 5.0 mm cord diameter was used to treat patients.

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
May 2026
Primary completion
Jan 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 4.0 Group
    4.0 mm diameter REFLECT cords were used to treat patients.
  • Arm: 5.0 Group
    5.0 mm diameter REFLECT cords were used to treat patients.

Primary Outcome Measure

REFLECT Cord Breakage/Separation [ Time Frame: by latest available time point (minimum 12 months postoperative) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone Orthopedic CenterNew YorkNew York11554
Korine Pagulayan
[email protected]
516-324-7500
Juan C Rodriguez-Olaverri, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
NYU Langone Orthopedic Center· New York, NY

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