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

NCT ID: NCT04684927

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2028-03-20

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.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MID-C treatment

Follow-up measurements during 5 years post MIC-C system implantationin order to evaluate safety and efficacy parameters.

Group Type: EXPERIMENTAL

MID-C System -Minimal invasive deformity correction system for the treatment of AIS

Intervention Type: DEVICE

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.

Interventions

MID-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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apifix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MID-C AIS 06-19

Identifier Type: -

Identifier Source: org_study_id