Globus Reflect Tether - HUD
Not Applicable
Not yet recruiting
- Conditions
- Scoliosis Idiopathic
- Interventions
- Procedure: REFLECT scoliosis correction system
- Registration Number
- NCT06521814
- Lead Sponsor
- Medical University of South Carolina
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Globus-tethering HUD patients REFLECT scoliosis correction system The implantation of the REFLECT scoliosis tethering system in patients diagnosed with idiopathic scoliosis.
- Primary Outcome Measures
Name Time Method Cobb angles Until patients reach the age of 18 Decrease in cobb angles for patients who are actively still growing
- Secondary Outcome Measures
Name Time Method