Globus Reflect Tether - HUD

NCT06521814 | Withdrawn DMC FDA Device

• 1 other identifier: Pro00132703
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Scoliosis Idiopathic

Outcome Measures

Primary Outcomes (1)

• Cobb angles

  Decrease in cobb angles for patients who are actively still growing

  Until patients reach the age of 18

Study Arms (1)

Globus-tethering HUD patients

EXPERIMENTAL

The implantation of the REFLECT scoliosis tethering system in patients diagnosed with idiopathic scoliosis.

Procedure: REFLECT scoliosis correction system

Interventions

REFLECT scoliosis correction system PROCEDURE

(i.e. purpose of research) 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. 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.

Globus-tethering HUD patients

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Officials

• Robert Murphy

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: November 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11