Scientific and radiological impact of medialized cortical bone trajectory for lumbar pedicle screw fixation in sufferers with degenerative lumbar spondylolisthesis: research protocol for a randomized managed trial (mPACT).
Trials. 2018 Feb 20;19(1):129
Authors: Tschugg A, Kavakebi P, Hartmann S, Lener S, Wipplinger C, Löscher WN, Neururer S, Wildauer M, Thomé C
BACKGROUND: Spinal fusion with pedicle screw fixation represents the gold commonplace for lumbar degenerative disc illness with instability. Though it’s a longtime approach, it’s however an invasive intervention with excessive complication charges. Subsequently, minimally invasive approaches have been developed, the medialized bilateral screw pedicel fixation (mPACT) being one in every of them. The research goal is to guage prospectively the efficacy and security of the mPACT approach in contrast with the standard trajectory for degenerative lumbar spondylolisthesis.
METHODS/DESIGN: It is a single-center, randomized, managed, parallel group, superiority trial. A complete of 154 grownup sufferers are allotted in a ratio of 1:1. Pattern dimension and energy calculation had been carried out to detect the minimal clinically necessary distinction of 10%, with an anticipated commonplace deviation of 20% within the major end result parameter, the Oswestry Incapacity Index, with energy of 80%, based mostly on an assumed maximal dropout charge of 20%. Secondary end result parameters embody the EuroQoL 5-Dimension questionnaire, the Beck Despair Stock, the painDETECT questionnaire and the “timed up and go” check. Moreover, radiological and well being financial outcomes can be evaluated. Comply with up is carried out till 5 years after surgical procedure. Main inclusion standards are lumbar degenerative spondylolisthesis with Meyerding grade I or II, which qualifies for decompression and fusion by medialised posterior screw placement with cortical trajectory (mPACT) or by a standard trajectory for lumbar pedicle screw placement.
DISCUSSION: This trial will contribute to the understanding of the short-term and long-term medical and radiological postoperative course in sufferers with lumbar degenerative disc illness, wherein the mPACT approach is used.
TRIAL REGISTRATION: ISRCTN registry, ISRCTN99263604 . Registered on three November 2016.
PMID: 29463278 [PubMed – in process]