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

Primary Purpose

Adolescent Idiopathic Scoliosis

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MID-C treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Efficacy endpoint

Maintenance of major Cobb angle ≤ 30° 5 years post-surgery

Safety endpoint

Serious adverse events, and device or procedure-related adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT04684927

First Posted

December 22, 2020

Last Updated

March 8, 2021

Sponsor

Apifix

1. Study Identification

Unique Protocol Identification Number

NCT04684927

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Withdrawn

Why Stopped

project not initiated

Study Start Date

January 20, 2021 (Anticipated)

Primary Completion Date

January 20, 2028 (Anticipated)

Study Completion Date

March 20, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Apifix

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adolescent Idiopathic Scoliosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MID-C treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Efficacy endpoint

Description

Maintenance of major Cobb angle ≤ 30° 5 years post-surgery

Time Frame

5 years post MID-C system implantation

Title

Safety endpoint

Description

Serious adverse events, and device or procedure-related adverse events

Time Frame

5 years post MID-C system implantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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