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

Adolescent Idiopathic Scoliosis Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04684927
• Other study ID #: MID-C AIS 06-19
• Status: Withdrawn
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: March 20, 2028

Study information

• Verified date: February 2021
• Source: Apifix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 20, 2028
• Est. primary completion date: January 20, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Apifix

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy endpoint	Maintenance of major Cobb angle = 30° 5 years post-surgery	5 years post MID-C system implantation
Primary	Safety endpoint	Serious adverse events, and device or procedure-related adverse events	5 years post MID-C system implantation