MASTERS-D 2 version 1.0
Research type
Research Study
Full title
A prospective, 5 year global study on MAST which is minimally invasive fusion procedures for the treatment of the degenerative lumbar spine.
IRAS ID
199331
Contact name
Shaishav Bhagat
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
The MASTERS D2 study: is a prospective study on MAST minimally invasive fusion procedures for the treatment of degenerative lumbar spine disease, to be conducted in approximately 38 centres worldwide. Approximately 560 patients will be enrolled over a period of 12 to 18 months and followed up for 5 years after undergoing surgery. The study is expected to run up to 7 years.
For patients that have been diagnosed with degenerative lumbar disc disease (Degenerative lumbar disc disease refers to a syndrome in the lumbar spine or lower back in which a compromised disc causes low back pain and/or leg pain) and are being considered to undergo back surgery, that is aimed at fusing and stabilizing 1 or 2 spinal column segments by way of minimally invasive spine surgery (MIS) with the use of Minimal Access Surgical Technologies (MAST).
There are a number of established minimally invasive spine surgery (MIS) techniques routinely undertaken to treat patients suffering from degenerative lumbar disc disease. However there is a need for additional long term clinical and economic data to be collected due to the following aspects:
• To assess long term (>2 years) patient outcomes after undergoing MAST™ lumbar fusion techniques.
• For larger (> 300 patients) patient populations, the documentation of patient outcomes is poor within currently available literature.
• There is also a need for additional cost effectiveness data surrounding patient’s treatment pathway.Within this research study we aim to observe and understand the standard of care surgical practice, its safety and effectiveness and evaluate patient's short and long term outcomes following minimally invasive spine surgery (MIS) with the use of Minimal Access Surgical Technologies (MAST).
REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0099
Date of REC Opinion
16 May 2016
REC opinion
Further Information Favourable Opinion