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)

Adolescent Idiopathic Scoliosis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04296903
• Other study ID #: MID-C-AIS-03-18
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2020
• Est. completion date: May 1, 2028

Study information

• Verified date: June 2023
• Source: Apifix
• Contact: Daphna Zaaroor-Regev, PhD
• Phone: +972523763653
• Email: Daphna[@]apifix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital of Atlanta (CHOA)	Atlanta	Georgia
United States	University of Virginia	Charlottesville	Virginia
United States	Rainbow babies and children	Cleveland	Ohio
United States	Women and Children's Hospital - University of Missouri Health Care	Columbia	Missouri
United States	Dayton Children's Hospital	Dayton	Ohio
United States	Lebonheur Children's Hospital	Germantown	Tennessee
United States	Riley Children's Health	Indianapolis	Indiana
United States	Univ. of Mississippi Medical Center (UMMC)	Jackson	Mississippi
United States	Wolfson children's hospital	Jacksonville	Florida
United States	Children's Mercy Hospital	Kansas City	Kansas
United States	Mount Sinai hospital	New York	New York
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	Shriners Hospitals for Children	Saint Louis	Missouri
United States	Rady Children's Hospital	San Diego	California
United States	Sanford Univ. of South Dakota Medical Center	Sioux Falls	South Dakota
United States	Lucile Packard Children's Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Apifix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance of major Cobb angle = 40° 5 years post-surgery	Spinal Cobb angle will be measured at 5 years post op. the percent of patients with Cobb angle = 40° 5 years post-surgery will be calculated	5 years