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

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 20, 2021

Primary Completion Date

January 20, 2028

Study Completion Date

March 20, 2028

Conditions
Adolescent Idiopathic Scoliosis
Interventions
DEVICE

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."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Apifix

INDUSTRY

NCT04684927 - PMS Evaluation of Safety and Efficacy of the MID-C System 5 Years Post-implantation in AIS | Biotech Hunter | Biotech Hunter