Status:
WITHDRAWN
PMS Evaluation of Safety and Efficacy of the MID-C System 5 Years Post-implantation in AIS
Lead Sponsor:
Apifix
Conditions:
Adolescent Idiopathic Scoliosis
Eligibility:
All Genders
10-18 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
- 1\. Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves; 2.
- Patients with Risser stage 0-1, primary Cobb angle between 35-50 degrees (inclusive), or
- Patients with Risser stage 0-1 and good brace compliant but curve progression above 6°, or
- Patients with Risser stage 0-1 that are non-compliant with brace treatment and primary Cobb angle between 30-50 degrees or
- Patients with Risser stage 2, primary Cobb angle between 40-50 degrees (inclusive) 3. Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray; 4. Kyphosis angles of ≤ 45 degrees measured from T5 to T12; 5. Appropriate candidate for posterior surgical approach; 6. Patient has good general health; 7. Patient has no known hypersensitivity or allergies to titanium; 8. 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;
- Cumulative vertebral wedging over the apex of the curve\>15º
- Known history of existing malignancy, or any systemic or local infection;
- Spinal cord abnormalities that require treatment;
- Known neurological deficit (defined as motor grades \< 5/5);
- Known poor bone quality defined as T score -1.5 or less;
- 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; and
- Systemic disease that would affect the patient's welfare or overall outcome of the study
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04684927
Start Date
January 20 2021
End Date
March 20 2028
Last Update
March 10 2021
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