The PROGRESS study
Research type
Research Study
Full title
A PROspective, single arm, sinGle-center study to assess the safety and perfoRmance of MagnEtOs Putty in patients undergoing Single/two-level Lateral Lumbar Interbody Fusion (XLIF).
IRAS ID
281370
Contact name
Panagiotis Liantis
Contact email
Sponsor organisation
KUROS BIOSCIENCES BV
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 23 days
Research summary
In this study, MagnetOs Putty will be applied according to the latest Instructions For Use (IFU) approved in Europe. Specifically, MagnetOs Putty will be used as bone void filler in Degenerative Disc Disease (DDD) patients with up to grade 1 spondylolisthesis requiring treatment with single or two-level lateral lumbar interbody fusion (XLIF).
The primary objective is to assess the safety and performance of MagnetOs Putty on the incidence of radiographic interbody fusion as determined by an independent radiology expert using CT-scans in patients undergoing single/two-level lateral lumbar interbody fusion (XLIF).
The primary endpoint is the rate of interbody fusion assessed by CT-scan at Month 12.
Radiographic fusion using CT-scan will be defined by an independent radiology expert at Month 12 post-surgery and determined by evidence of bridging trabeculae or continuous bony connection between superior and inferior vertebral body.Following a screening period of maximum 30 days, 20 patients will undergo a single/two-level XLIF procedure and will receive MagnetOs Putty at the diseased level(s). They will be followed up at discharge, Week 6, Month 3, Month 6 and Month 12 post-surgery. The primary endpoint will be analyzed at Month 12.
REC name
London - Stanmore Research Ethics Committee
REC reference
20/LO/0665
Date of REC Opinion
17 Jun 2020
REC opinion
Further Information Favourable Opinion