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

• ClinicalTrials.gov Identifier: NCT04684927
• Recruitment Status: Withdrawn
• First Posted: December 28, 2020
• Last Update Posted: March 10, 2021
• Sponsor: Apifix
• Information provided by (Responsible Party): Apifix

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Adolescent Idiopathic Scoliosis	Device: MID-C System -Minimal invasive deformity correction system for the treatment of AIS	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: The study is a prospective, single arm, non-randomized, new enrollment cohort study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Estimated Study Start Date: January 20, 2021
• Estimated Primary Completion Date: January 20, 2028
• Estimated Study Completion Date: March 20, 2028

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Efficacy endpoint [ Time Frame: 5 years post MID-C system implantation ]
   Maintenance of major Cobb angle ≤ 30° 5 years post-surgery
2. Safety endpoint [ Time Frame: 5 years post MID-C system implantation ]
   Serious adverse events, and device or procedure-related adverse events

Eligibility Criteria

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

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Apifix
• ClinicalTrials.gov Identifier: NCT04684927
• Other Study ID Numbers: MID-C AIS 06-19
• First Posted: December 28, 2020
• Last Update Posted: March 10, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Scoliosis; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases