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

NCT04684927 | Withdrawn

• 1 other identifier: MID-C AIS 06-19
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

MID-C treatment

EXPERIMENTAL

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

Interventions

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

MID-C treatment

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. 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).

You may not qualify if:

• Any type of non-idiopathic scoliosis;
• Any main thoracic deformity that includes vertebral levels and cranial including to T2;
• Cumulative vertebral wedging over the apex of the curve\>15º
• Known history of existing malignancy, or any systemic or local infection;
• Spinal cord abnormalities that require treatment;
• Known neurological deficit (defined as motor grades \< 5/5);
• Known poor bone quality defined as T score -1.5 or less;
• Previous spine surgery that would prevent the successful performance of the MID-C system;
• Active systemic disease, such as AIDS, HIV, or active infection;
• Active infection or the skin is compromised at the surgical site; and
• Systemic disease that would affect the patient's welfare or overall outcome of the study

Sponsors & Collaborators

• Apifix: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a prospective, single arm, non-randomized, new enrollment cohort study

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: January 20, 2021
• Primary Completion (Estimated): January 20, 2028
• Study Completion (Estimated): March 20, 2028
• Last Updated: March 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share