PMCF Study to evaluate the Safety and efficacy of the MID-C system
Research type
Research Study
Full title
Post-Market Clinical Follow-Up (PMCF) Study to evaluate the Safety and efficacy of the MID-C system in Adolescent idiopathic scoliosis (AIS)
IRAS ID
224222
Contact name
JASON BERNARD
Contact email
Sponsor organisation
ApiFix
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
This is a post marketing clinical follow up observational, non-interventional 1 arm study involving patients who will be treated with the MID-C system. The MID-C system is a CE certified system designed to treat Adolescent Idiopathic Scoliosis (AIS). The device is designed to increase its length as the patient bends to the corrective direction and maintain the correction as the patient gets back to the normal position. Adolescents aged 11-17 with AIS will be recruited into the study. The primary goal of the study is to capture data on MID-C use in actual practice real-life setting.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0270
Date of REC Opinion
30 Aug 2017
REC opinion
Further Information Favourable Opinion