Globus Reflect Tether - HUD

Medical University of South Carolina (MUSC)

Status: Withdrawn

Conditions: Scoliosis Idiopathic

Treatments: Procedure: REFLECT scoliosis correction system

Study type: Interventional

Funder types: Other

Identifiers

NCT06521814

Pro00132703

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 10 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Globus-tethering HUD patients

Experimental group

Description:

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

Treatment:

Procedure: REFLECT scoliosis correction system