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PMS Evaluation of Safety and Efficacy of the MID-C System 5 Years Post-implantation in AIS

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:
Post-approval Study to Evaluate the Continued Safety and Efficacy of the MID-C System 5 Years Post-implantation in Adolescent Idiopathic Scoliosis (AIS)

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. A total of 10 patients, who are planned to undrego the MID-C System implantation procedure will be enrolled for the study. A 5 years follow-up post surgery will be performed for these patients in order to evaluate the long term safety and efficacy of the MID-C System.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04684927
Study type Interventional
Source Apifix
Contact
Status Withdrawn
Phase N/A
Start date January 20, 2021
Completion date March 20, 2028
View Details
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