Adolescent Idiopathic Scoliosis
Conditions
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. A total of 10 patients, who are planned to undrego the MID-C System implantation procedure will be enrolled for the study. A 5 years follow-up post surgery will be performed for these patients in order to evaluate the long term safety and efficacy of the MID-C System.
Interventions
DEVICEMID-C System -Minimal invasive deformity correction system for the treatment of AIS
A 5 years follow-up will be performed for all patients who underwent AIS repair surgery using the MID-C System. The follow-up in order to assess safety and efficacy measurments. Eligible Patients will be followed and assessed at the following time points: Immediate Post-op up to 6 weeks, 6 months, 12 months, and then annually out to 5 years post-implantation. During the study, the following rating scales and assessments will be conducted to assess the probable benefit and safety of the treatment: Physical exam,X-rays,Cobb angle measurements,Adverse Events (AEs) and Scoliosis research society (SRS-22) questionnaire: The questionnaire is commonly used to assess health related quality of life in children with AIS.
Sponsors
Apifix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is a prospective, single arm, non-randomized, new enrollment cohort study
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
1. Any type of non-idiopathic scoliosis; 2. Any main thoracic deformity that includes vertebral levels and cranial including to T2; 3. Cumulative vertebral wedging over the apex of the curve\>15º 4. Known history of existing malignancy, or any systemic or local infection; 5. Spinal cord abnormalities that require treatment; 6. Known neurological deficit (defined as motor grades \< 5/5); 7. Known poor bone quality defined as T score -1.5 or less; 8. Previous spine surgery that would prevent the successful performance of the MID-C system; 9. Active systemic disease, such as AIDS, HIV, or active infection; 10. Active infection or the skin is compromised at the surgical site; and 11. Systemic disease that would affect the patient's welfare or overall outcome of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoint | 5 years post MID-C system implantation | Maintenance of major Cobb angle ≤ 30° 5 years post-surgery |
| Safety endpoint | 5 years post MID-C system implantation | Serious adverse events, and device or procedure-related adverse events |
Outcome results
None listed