Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Apifix
Conditions:
Adolescent Idiopathic Scoliosis
Eligibility:
All Genders
10+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
May 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2030
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT04296903
Start Date
May 31 2020
End Date
June 30 2030
Last Update
October 3 2025
Active Locations (14)
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1
Rady Children's Hospital
San Diego, California, United States, 92123
2
Wolfson children's hospital
Jacksonville, Florida, United States, 32207
3
Wellstar
Atlanta, Georgia, United States, 30060
4
Riley Children's Health
Indianapolis, Indiana, United States, 46202