RCT USS2 versus Rail Rod in posterior idiopathic scoliosis correction
Research type
Research Study
Full title
Randomised controlled trial comparing USS2/URS hybrid to Rail rod correction of posterior thoracic Lenke 1 curves
IRAS ID
134320
Contact name
Evan Davies
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
4 years, 1 months, 1 days
Research summary
Adolescent Idiopathic Scoliosis (AIS) is a complex three-dimensional structural deformity of the spine that occurs most commonly in girls between ages 10 and 18 with a prevalence rate of 2%–4%. Subjects between the ages of 11 and 18 with a diagnosis of AIS requiring surgical treatment for selective thoracic/lumbar fusion will be enrolled.
The purpose of this study is to evaluate the restoration and maintenance of kyphosis (excessive outward curvature of the spine) and coronal curve correction using the K2M MESA Rail Deformity System and to demonstrate superiority when compared to outcomes gathered from use of the DePuy Synthes USS II System. Both systems are currently used within the NHS. Participants will be randomised to receive either the Mesa Rail system or the USS II System. Participants randomised to receive the USS II System will be controls. The participants will then undergo surgery as per routine care and will be followed up for two years.
60 patients will be enrolled at the University Hospital Southampton NHS Foundation Trust.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0378
Date of REC Opinion
4 Dec 2017
REC opinion
Further Information Favourable Opinion