A Retrospective Review of Clinical and Radiographic Outcomes Following the Use of the REFLECT™ Scoliosis Correction System in the Treatment of Idiopathic Scoliosis
Globus Medical Inc
Summary
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.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects must meet all of the following criteria to be included in the study: 1. Requires surgical treatment to obtain and maintain correction of idiopathic scoliosis 2. Skeletally immature 3. Major Cobb angle of 30° and 65° 4. Bone structure adequate to safely accommodate screw fixation 5. Failed bracing treatment and/or intolerant to brace wear 6. Treated with the REFLECT™ Scoliosis Correction System, using single or dual REFLECT cord(s) per curve 7. Availability of medical and radiographic records evaluating the product under study preoperatively through a minimum of 1…
Interventions
- DeviceScoliosis Correction System
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.
- DeviceScoliosis Correction System
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.
Locations (3)
- NYU Langone Orthopedic CenterNew York, New York
- Eifel Clinic St. Brigida GmbH & Co. KGSimmerath, Simmerath
- Acibadem Maslak HospitalIstanbul, I