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

Post-approval Study to Evaluate the Continued Safety and Efficacy of the MID-C System 5 Years Post-implantation in Adolescent Idiopathic Scoliosis (AIS)

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.

Study Overview

• Status: Withdrawn
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Device: MID-C System -Minimal invasive deformity correction system for the treatment of AIS

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Apifix

Study record dates

Study Major Dates

• Study Start (Anticipated): January 20, 2021
• Primary Completion (Anticipated): January 20, 2028
• Study Completion (Anticipated): March 20, 2028

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: MID-C AIS 06-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No