Globus Reflect Tether - HUD

Medical University of South Carolina

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Scoliosis Idiopathic

Interventions

REFLECT scoliosis correction systemPROCEDURE

(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.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cobb angles

Decrease in cobb angles for patients who are actively still growing

Time frame: Until patients reach the age of 18

Data from ClinicalTrials.gov

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