Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-31

Study Completion Date

2030-06-30

Brief Summary

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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. Patients implanted with the device in the US within 2 years of FDA's approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study.

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Detailed Description

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Conditions

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Adolescent Idiopathic Scoliosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective Registry, multi center, single arm, non-randomized, new enrollment cohort study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MID-C treatment

Group Type EXPERIMENTAL

MID-C System

Intervention Type DEVICE

Minimal invasive deformity correction system for the treatment of AIS

Interventions

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MID-C System

Minimal invasive deformity correction system for the treatment of AIS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves;
* Cobb angle between 35-60 degrees (inclusive);
* Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray;
* Kyphosis angles of ≤ 55 degrees measured from T5 to T12;
* Appropriate candidate for posterior surgical approach;
* Patient has good general health;
* Patient has no known hypersensitivity or allergies to titanium;
* 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;
* Known history of existing malignancy, or any systemic or local infection;
* Spinal cord abnormalities that require treatment;
* Known neurological deficit (defined as motor grade \< 5/5);
* Known poor bone quality defined as T score -1.5 or less;
* For female Patient, pregnancy;
* 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;
* Systemic disease that would affect the Patient's welfare or overall outcome of the study.

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No