Preservation of Thoracic Kyphosis Using the K2M MESA Rail System
Research type
Research Study
Full title
Post- Marketing Surveillance study: Preservation of Thoracic Kyphosis and Coronal Curve Correction as a Function of Rod Stiffness in the Surgical Treatment of Adolescent Idiopathic Scoliosis with the Use of the K2M MESA Rail Deformity System
IRAS ID
155985
Contact name
Stewart Tucker
Contact email
Sponsor organisation
K2M, Inc.
Clinicaltrials.gov Identifier
Research summary
This study is aimed to evaluate the restoration and maintenance of thoracic kyphosis (kyphosis is forward rounding of the back, in this case occuring in the top half of the spine) and coronal curve correction (correction of sideways bending of the spine) demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as compared to literature reported outcomes for standard Cobalt Chrome (CoCr) rod systems in the treatment of Adolescent Idiopathic Scoliosis (AIS). Currently various systems are in use to correct the sideways bend of the spine, but very little data exist to look at their use and how well they perfome and maintain the correction, and their use in relation to patient satisfaction. This is a study looking at existing system used in standard practice whereby data and patient reported outcome measures already obtained during the course of standard care are collected in order to evaluate the system. There will be no additional procedures introduced during the conduct of the study.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/1094
Date of REC Opinion
30 Jul 2014
REC opinion
Further Information Favourable Opinion