Status:
WITHDRAWN
Globus Reflect Tether - HUD
Lead Sponsor:
Medical University of South Carolina
Conditions:
Scoliosis Idiopathic
Eligibility:
All Genders
10-18 years
Phase:
NA
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 plac...
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, instea...
Eligibility Criteria
Inclusion
- 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
- 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 Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06521814
Start Date
November 1 2025
End Date
November 1 2025
Last Update
November 18 2025
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