The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to act as an internal brace. Patients implanted with the device in the US within 2 years of FDA's approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
201
Minimal invasive deformity correction system for the treatment of AIS
Rady Children's Hospital
San Diego, California, United States
Wolfson children's hospital
Jacksonville, Florida, United States
Wellstar
Atlanta, Georgia, United States
Riley Children's Health
Indianapolis, Indiana, United States
Children's Mercy Hospital
Kansas City, Kansas, United States
Mayo Clinic
Rochester, Minnesota, United States
Univ. of Mississippi Medical Center (UMMC)
Jackson, Mississippi, United States
Women and Children's Hospital - University of Missouri Health Care
Columbia, Missouri, United States
Shriners Hospitals for Children
St Louis, Missouri, United States
Mount Sinai hospital
New York, New York, United States
...and 4 more locations
Maintenance of major Cobb angle ≤ 40° 5 years post-surgery
Spinal Cobb angle will be measured at 5 years post op. the percent of patients with Cobb angle ≤ 40° 5 years post-surgery will be calculated
Time frame: 5 years
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