SILVIA
Research type
Research Study
Full title
SIJ Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial
IRAS ID
278046
Contact name
Robert Lee
Contact email
Sponsor organisation
SI-BONE, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
A Prospective, single-blind randomized controlled trial designed to evaluate the effects of the additional placement of iFuse-3D across the sacrum and into the ilium (pelvic bone) in patients with certain spine conditions undergoing MLF surgery. Since the iFuse-3D is already CE marked for this type of use, this study is called a “post-market” study.
The primary aim of the study is to understand the outcomes of using iFuse-3D in the Bedrock configuration in patients undergoing MLF surgery. Each trial participant will be randomized to either receive MLF surgery with or without iFuse-3D placement. The effect on patient function, pain and overall safety will be studied in a maximum of 220 patients in the trial, at up to 25 research centres. Additionally, a CT scan at 2 years will evaluate the hardware placed into the pelvis for problems such as loosening or breakage.
The company is supporting the study so they can share the results with doctors and patients making health care decisions in the future. Participation in this trial may also help future patients with SI joint conditions related to adult scoliosis and other spine conditions.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
20/YH/0073
Date of REC Opinion
17 Jun 2020
REC opinion
Further Information Favourable Opinion