PMS Evaluation of Safety and Efficacy of the MID-C System 5 Years Post-implantation in AIS

Not Applicable

Withdrawn

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Device: MID-C System -Minimal invasive deformity correction system for the treatment of AIS

• Registration Number: NCT04684927
• 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Study Start: 2021-01-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10
• Primary Completion: 2028-01-20
• Study Completion: 2028-03-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MID-C treatment	MID-C System -Minimal invasive deformity correction system for the treatment of AIS	Follow-up measurements during 5 years post MIC-C system implantationin order to evaluate safety and efficacy parameters.

Primary Outcome Measures

Name	Time	Method
Safety endpoint	5 years post MID-C system implantation	Serious adverse events, and device or procedure-related adverse events
Efficacy endpoint	5 years post MID-C system implantation	Maintenance of major Cobb angle ≤ 30° 5 years post-surgery