Start Date
January 20, 2021
Primary Completion Date
January 20, 2028
Study Completion Date
March 20, 2028
MID-C System -Minimal invasive deformity correction system for the treatment of AIS
"A 5 years follow-up will be performed for all patients who underwent AIS repair surgery using the MID-C System. The follow-up in order to assess safety and efficacy measurments. Eligible Patients will be followed and assessed at the following time points: Immediate Post-op up to 6 weeks, 6 months, 12 months, and then annually out to 5 years post-implantation.~During the study, the following rating scales and assessments will be conducted to assess the probable benefit and safety of the treatment: Physical exam,X-rays,Cobb angle measurements,Adverse Events (AEs) and Scoliosis research society (SRS-22) questionnaire: The questionnaire is commonly used to assess health related quality of life in children with AIS."
Lead Sponsor
Apifix
INDUSTRY