NCT03519321

Minimal Invasive Deformity Correction (MID-C) System for Early Onset Scoliosis

Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Early Onset Scoliosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Apifix · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

Early Onset Scoliosis (EOS) is defined as scoliosis with onset under the age of ten years, regardless of etiology. It is a complex three-dimensional deformity of the spine which can cause significant physical and psychological problems. Currently there are two basic treatment options available for EOS: non-surgical and surgical. ApiFix Ltd. has developed a novel growing rod system for surgical treatment of EOS, the MID-C system. It is indicated for patients with a scoliosis of 35 to 75 degrees Cobb angle

Conditions

• Scoliosis
• Scoliosis Idiopathic
• Scoliosis;Congenital

Interventions

Type	Name	Description
DEVICE	MID-C	The MID-C system is being connected to the spine via standard unilateral posterior approach. Pedicle screws above and below the main curve are being used to attach the device to the selected vertebra.

Timeline

• Start date: 2018-04-11
• Primary completion: 2023-06-20
• Completion: 2023-07-20
• First posted: 2018-05-08
• Last updated: 2021-07-22

Locations

1 site across 1 country: Greece