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)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Apifix · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adolescent Idiopathic Scoliosis

Interventions

Type	Name	Description
DEVICE	MID-C System	Minimal invasive deformity correction system for the treatment of AIS

Timeline

• Start date: 2020-05-31
• Primary completion: 2029-06-30
• Completion: 2030-06-30
• First posted: 2020-03-05
• Last updated: 2025-10-03

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study