Globus Reflect Tether - HUD

Globus Reflect Tether - Humanitarian Use Device

NCT06521814•Medical University of South Carolina

Summary

The purpose of this device is to treat children and adolescents with scoliosis who have growth remaining. In patients with a curvature about the spine, Reflect holds the convexity of the curve in place so that the concavity can grow, thereby harnessing the power of normal spine growth to correct the deformity.

Detailed Description

The Globus Reflect scoliosis correction system aims to provide curve correction for scoliosis patients who are still actively growing. Surgical correction is accomplished without spinal fusion, instead utilizing anterior vertebral body tethering. This device received an HDE exemption from the FDA and requires MUSC IRB approval to be used.

Eligibility

Age

10 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 35 to 60 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging.
•Patients should have failed bracing and/or be intolerant to brace wear.

Exclusion Criteria

•Pregnancy (current)
•Prior spinal or chest surgery
•MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord)
•Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis
•Associated syndrome, including Marfan Disease or Neurofibromatosis
•Sanders stage greater than 4
•Thoracic curve less than 35 or greater than 60
•Lumbar curve greater than or equal to 35
•Unable or unwilling to firmly commit to returning for required follow-up visits
•Investigator judgement that the subject/family may not be a candidate for the intervention

Key Dates

Start Date

November 1, 2025

Primary Completion Date

November 1, 2025

Completion Date

November 1, 2025

Last Updated

November 18, 2025

Conditions

Scoliosis Idiopathic

Interventions

REFLECT scoliosis correction system

PROCEDURE

Post-market Clinical Follow-up Study of NEMOST V2

NCT07403084

Scoliosis NeuromuscularScoliosis Idiopathic+1 more

View study

RECRUITINGNA

Inspiratory Muscle Training in Children and Adolescents With Idiopathic Scoliosis Undergoing Schroth Therapy.

NCT07177430

Scoliosis Idiopathic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Globus Reflect Tether - HUD

Inclusion Criteria

Exclusion Criteria

Post-market Clinical Follow-up Study of NEMOST V2

Inspiratory Muscle Training in Children and Adolescents With Idiopathic Scoliosis Undergoing Schroth Therapy.

Scoliosis-Specific Exercises on Physical Fitness Parameters

The Effect of Dexamethasone Administration Route and Local Anesthetic Concentration on Pain, Inflammatory Response, and Neuromonitoring in Children Undergoing Scoliosis Correction

Physiotherapy and Whole-Body Vibration in Adolescent Idiopathic Scoliosis

IMU-based Assessment of Motor Control in a Population of Young Subjects With Paramorphisms and Dysmorphisms