“MAST” prospective study: Value of minimal access spine technologies technique for multicolumn spinal cord stimulation surgical lead implantation in the context of a French multicentre randomized controlled trial (ESTIMET study)

Abstract

Background and purposeSpinal cord stimulation (SCS) has been demonstrated to be an effective treatment for postoperative persistent leg pain after spine surgery, but treatment of the back pain component remains much more difficult, as it comprises mixed neuropathic and mechanical pain mechanisms. Moreover, these patients could present damaged tissues at the site of SCS lead implantation as a result of previous spine surgery. It can therefore be logically assumed that minimizing the surgical invasiveness of SCS implantation would be beneficial for these patients. Several studies have demonstrated the value of Minimal Access Spine Technologies (MAST) in spine surgery, but only a few case reports have been published concerning the use of MAST techniques for SCS. Therefore, we were prompted to conduct a second ESTIMET ancillary study to prospectively analyse the potential impact and benefits of MAST technique during SCS lead implantation versus an open surgical approach. MethodsThis is a multicentre, comparative, ancillary study conducted in 61 patients among the 115 enrolled patients ESTIMET study. One arm comprises patients undergoing multicolumn lead implantation via a Conventional Open Approach (COA) and the other arm comprises patients implanted by a MAST approach. Patients will be followed for 12 months after lead implantation. The following data will be collected: elevation of muscle enzymes (serum CPK), scar size, blood loss, infection rate, operating time and global, leg, back and scar NPRS. Trial statusThe first patient of this ancillary study was enrolled on 21 May 2012 and recruitment has now been achieved. Primary endpoint findings are expected to be available in 2015. ConclusionMinimally invasive techniques have now been used for spine surgery for the past 12 years, and could also be useful in the context of SCS lead implantation, especially in patients with chronic back pain prior to implantation.