Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)
- Conditions
- Adolescent Idiopathic Scoliosis
- Interventions
- Device: MID-C System
- Registration Number
- NCT04296903
- Lead Sponsor
- Apifix
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves;
- Cobb angle between 35-60 degrees (inclusive);
- Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray;
- Kyphosis angles of ≤ 55 degrees measured from T5 to T12;
- Appropriate candidate for posterior surgical approach;
- Patient has good general health;
- Patient has no known hypersensitivity or allergies to titanium;
- Patient's guardian signs a written informed consent form (ICF).
- Any type of non-idiopathic scoliosis;
- Any main thoracic deformity that includes vertebral levels and cranial including to T2;
- Known history of existing malignancy, or any systemic or local infection;
- Spinal cord abnormalities that require treatment;
- Known neurological deficit (defined as motor grade < 5/5);
- Known poor bone quality defined as T score -1.5 or less;
- For female Patient, pregnancy;
- Previous spine surgery that would prevent the successful performance of the MID-C system ;
- Active systemic disease, such as AIDS, HIV, or active infection;
- Active infection or the skin is compromised at the surgical site;
- Systemic disease that would affect the Patient's welfare or overall outcome of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MID-C treatment MID-C System -
- Primary Outcome Measures
Name Time Method Maintenance of major Cobb angle ≤ 40° 5 years post-surgery 5 years 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Wolfson children's hospital
🇺🇸Jacksonville, Florida, United States
Wellstar
🇺🇸Atlanta, Georgia, United States
Children's Hospital of Atlanta (CHOA)
🇺🇸Atlanta, Georgia, United States
Avera Health
🇺🇸Sioux Falls, South Dakota, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Riley Children's Health
🇺🇸Indianapolis, Indiana, United States
Children's Mercy Hospital
🇺🇸Kansas City, Kansas, United States
Dayton Children's Hospital
🇺🇸Dayton, Ohio, United States
Shriners Hospitals for Children
🇺🇸Saint Louis, Missouri, United States
Univ. of Mississippi Medical Center (UMMC)
🇺🇸Jackson, Mississippi, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Women and Children's Hospital - University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Rainbow babies and children
🇺🇸Cleveland, Ohio, United States
Mount Sinai hospital
🇺🇸New York, New York, United States