Clinical trial NCT04296903: 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)
Official title: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: Apifix
Sponsor class: INDUSTRY
First posted: 2020-03-05
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Registry, multi center, single arm, non-randomized, new enrollment cohort study
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maintenance of major Cobb angle ≤ 40° 5 years post-surgery
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Jacksonville
country: United States
facility: Wolfson children's hospital
state: Florida
city: Atlanta
country: United States
facility: Wellstar
state: Georgia
city: Atlanta
country: United States
facility: Children's Hospital of Atlanta (CHOA)
state: Georgia
city: Indianapolis
country: United States
facility: Riley Children's Health
state: Indiana
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Kansas
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: Univ. of Mississippi Medical Center (UMMC)
state: Mississippi
city: Columbia
country: United States
facility: Women and Children's Hospital - University of Missouri Health Care
state: Missouri
city: Saint Louis
country: United States
facility: Shriners Hospitals for Children
state: Missouri
city: New York
country: United States
facility: Mount Sinai hospital
state: New York
city: Cleveland
country: United States
facility: Rainbow babies and children
state: Ohio
city: Dayton
country: United States
facility: Dayton Children's Hospital
state: Ohio
city: Sioux Falls
country: United States
facility: Avera Health
state: South Dakota
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: