Clinical trial NCT04684927: PMS Evaluation of Safety and Efficacy of the MID-C System 5 Years Post-implantation in AIS
Official title: Post-approval Study to Evaluate the Continued Safety and Efficacy of the MID-C System 5 Years Post-implantation in Adolescent Idiopathic Scoliosis (AIS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: Apifix
Sponsor class: INDUSTRY
First posted: 2020-12-28
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a prospective, single arm, non-randomized, new enrollment cohort study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy endpoint
timeFrame: 5 years post MID-C system implantation
measure: Safety endpoint
timeFrame: 5 years post MID-C system implantation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: