This study reviews medical records of children and adolescents treated for idiopathic scoliosis (a sideways curve of the spine with no known cause) using the REFLECT™ Scoliosis Correction System.
Study Type
OBSERVATIONAL
Enrollment
100
The REFLECT system is a non-fusion spinal device, meaning it corrects scoliosis without permanently fusing the spine. Instead of rigid metal rods, it uses a flexible polymer cord attached to screws. For this intervention, a 4.0 mm cord diameter was used to treat patients.
The REFLECT system is a non-fusion spinal device, meaning it corrects scoliosis without permanently fusing the spine. Instead of rigid metal rods, it uses a flexible polymer cord attached to screws. For this intervention, a 5.0 mm cord diameter was used to treat patients.
NYU Langone Orthopedic Center
New York, New York, United States
Eifel Clinic St. Brigida GmbH & Co. KG
Simmerath, Simmerath, Germany
Acibadem Maslak Hospital
Istanbul, I, Turkey (Türkiye)
REFLECT Cord Breakage/Separation
Comparison of REFLECT cord breakage/separation rate (radiographically suspected or confirmed) in 4.0 mm vs. 5.0 mm cords
Time frame: by latest available time point (minimum 12 months postoperative)
Subsequent Surgeries Related to Cord Breakage
Rate of subsequent surgeries at the treatment levels associated with REFLECT cord breakage/separation
Time frame: by latest available time point (minimum 12 months postoperative)
Complications Profile
Rate of all complications attributable to the REFLECT system
Time frame: up to the latest available follow-up visit, with a required minimum of 12 months after surgery.
All Subsequent Surgeries
Rate of all subsequent surgeries at the treatment levels that are associated with the REFLECT system
Time frame: up to the latest available follow-up visit, with a required minimum of 12 months after surgery.
Change in Curve
Change in curve(s), as measured by the change in Cobb angle(s)
Time frame: From baseline (preoperative) to each postoperative time point.
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