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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)

Sponsor
Apifix (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04296903
Collaborator
(none)
200
Enrollment
20
Locations
1
Arm
95
Anticipated Duration (Months)
10
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Device: MID-C System
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective Registry, multi center, single arm, non-randomized, new enrollment cohort studyProspective Registry, multi center, single arm, non-randomized, new enrollment cohort study
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
May 31, 2020
Anticipated Primary Completion Date :
May 1, 2027
Anticipated Study Completion Date :
May 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: MID-C treatment

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

Outcome Measures

Primary Outcome Measures

  1. Maintenance of major Cobb angle ≤ 40° 5 years post-surgery [5 years]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Phoenix Children's Hospital Phoenix Arizona United States 85016
2 Rady Children's Hospital San Diego California United States 92123
3 Lucile Packard Children's Hospital Stanford California United States 94304.
4 Wolfson children's hospital Jacksonville Florida United States 32207
5 Paley Orthopedic institute St. Mary Medical Center West Palm Beach Florida United States 33407
6 Children's Hospital of Atlanta (CHOA) Atlanta Georgia United States 30329
7 Advocate Lutheran General Hospital Chicago Illinois United States 60068
8 Riley Children's Health Indianapolis Indiana United States 46202
9 Children's Mercy Hospital Kansas City Kansas United States 64108
10 Boston Children's Hospital Boston Massachusetts United States 02115
11 Mayo Clinic Rochester Minnesota United States 55902
12 Univ. of Mississippi Medical Center (UMMC) Jackson Mississippi United States 39216
13 Women and Children's Hospital - University of Missouri Health Care Columbia Missouri United States 65201
14 Shriners Hospitals for Children Saint Louis Missouri United States 63110
15 Mount Sinai hospital New York New York United States 10029
16 Rainbow babies and children Cleveland Ohio United States 44106
17 Dayton Children's Hospital Dayton Ohio United States 45404
18 Sanford Univ. of South Dakota Medical Center Sioux Falls South Dakota United States 57117
19 Lebonheur Children's Hospital Germantown Tennessee United States 38138
20 University of Virginia Charlottesville Virginia United States 22903

Sponsors and Collaborators

  • Apifix

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Apifix
ClinicalTrials.gov Identifier:
NCT04296903
Other Study ID Numbers:
  • MID-C-AIS-03-18
First Posted:
Mar 5, 2020
Last Update Posted:
Apr 29, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Scoliosis

Study Results

No Results Posted as of Apr 29, 2022