Globus Reflect Tether - HUD

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Jul 22, 2024

Keywords

ClinConnect Summary

The Globus Reflect Tether clinical trial is studying a new device designed to help treat children and teenagers with idiopathic scoliosis, a condition where the spine curves abnormally. This device aims to hold the curved part of the spine in place, allowing the straighter side to grow normally. By doing this, the treatment hopes to correct the spinal deformity as the child grows. The trial is not yet recruiting participants, but it will look for young patients aged between 1 and 18 who still have growth potential and need surgical help after unsuccessful attempts with braces.

To be eligible for this trial, patients should have a significant curvature of their spine (between 35 and 60 degrees) and must have been unable to wear a brace or have found it ineffective. However, individuals who are pregnant, have certain prior surgeries, or have other specific spinal issues will not be allowed to participate. If selected, participants can expect to receive this innovative treatment and will need to return for regular follow-up visits to monitor their progress. This trial represents an exciting opportunity to explore a new approach to managing scoliosis in growing children.

Gender

ALL

Eligibility criteria

• 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