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ClinicalTrials.gov ID

NCT07589023

Lead Sponsor

Globus Medical IncINDUSTRY

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

100Estimated

Last Update Posted

May 15, 2026Actual

Start Date

Jun 15, 2026Estimated

Primary Completion Date

Jan 30, 2027Estimated

Completion Date

Jul 31, 2027Estimated

Official Title

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

Brief Summary

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.

• Idiopathic Scoliosis

• Scoliosis Correction System

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Retrospective

Lead Sponsor

Globus Medical IncINDUSTRY

tais.zulemyan@gmail.com+90 212 304 36 36