REFLECT
Research type
Research Study
Full title
Treatment of Adolescent Idiopathic Scoliosis Using the REFLECT Scoliosis Correction System: A Prospective Evaluation of Clinical Outcomes
IRAS ID
261907
Contact name
Julian Leong
Contact email
Sponsor organisation
Globus Medical Inc
Duration of Study in the UK
2 years, 11 months, 28 days
Research summary
Idiopathic scoliosis (curve in the spine, which prevents normal posture) is a complex condition that often requires surgical intervention to improve the curve and prevent curve progression. Corrections of the deformity usually comprise of surgical treatment and involve multi-fusion. While fusion remains a practical option, it limits spinal mobility and may cause other complications.
Non-fusion treatment is now available and offers the benefit of curve correction without the loss of mobility. One such system is the REFLECT™ Scoliosis Correction System which involves of a growth modulation technique whereby a polymer cord is used to achieve correction of the curve and allow flexibility. This technique is referred to as tethering. NHS England published recommendations for further research required to enable use of spinal tethering in the NHS.
The goal of this study is to collect further information and provide evidence about the usage of tethering. Information on radiographic and clinical outcomes of patients who are treated with the REFLECT™ Scoliosis Correction System for Adolescent Idiopathic Scoliosis will be collected. Data from this study may be used to support applications for reimbursement/creation of NHS tariff as well as regulatory approvals for the REFLECT™ System in the United States and other geographies.
A total of 30 subjects will be enrolled and treated by investigators at this institution. Patients will be followed until they have reached 24 months postoperative follow-up.REC name
London - Stanmore Research Ethics Committee
REC reference
19/LO/1627
Date of REC Opinion
10 Dec 2019
REC opinion
Further Information Favourable Opinion