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Clinical and radiological effect of medialized cortical bone trajectory for lumbar pedicle screw fixation in patients with degenerative lumbar spondylolisthesis: study protocol for a randomized controlled trial (mPACT).

ABSTRACT: BACKGROUND:Spinal fusion with pedicle screw fixation represents the gold standard for lumbar degenerative disc disease with instability. Although it is an established technique, it is nevertheless an invasive intervention with high complication rates. Therefore, minimally invasive approaches have been developed, the medialized bilateral screw pedicel fixation (mPACT) being one of them. The study objective is to evaluate prospectively the efficacy and safety of the mPACT technique compared with the traditional trajectory for degenerative lumbar spondylolisthesis. METHODS/DESIGN:This is a single-center, randomized, controlled, parallel group, superiority trial. A total of 154 adult patients are allocated in a ratio of 1:1. Sample size and power calculation were performed to detect the minimal clinically important difference of 10%, with an expected standard deviation of 20% in the primary outcome parameter, the Oswestry Disability Index, with power of 80%, based on an assumed maximal dropout rate of 20%. Secondary outcome parameters include the EuroQoL 5-Dimension questionnaire, the Beck Depression Inventory, the painDETECT questionnaire and the "timed up and go" test. Furthermore, radiological and health economic outcomes will be evaluated. Follow up is performed until 5 years after surgery. Major inclusion criteria 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 traditional trajectory for lumbar pedicle screw placement. DISCUSSION:This trial will contribute to the understanding of the short-term and long-term clinical and radiological postoperative course in patients with lumbar degenerative disc disease, in which the mPACT technique is used. TRIAL REGISTRATION:ISRCTN registry, ISRCTN99263604 . Registered on 3 November 2016.

SUBMITTER: Tschugg A

PROVIDER: S-EPMC5819638 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Clinical and radiological effect of medialized cortical bone trajectory for lumbar pedicle screw fixation in patients with degenerative lumbar spondylolisthesis: study protocol for a randomized controlled trial (mPACT).

Tschugg Anja A Kavakebi Pujan P Hartmann Sebastian S Lener Sara S Wipplinger Christoph C Löscher Wolfgang N WN Neururer Sabrina S Wildauer Matthias M Thomé Claudius C

Trials 20180220 1

<h4>Background</h4>Spinal fusion with pedicle screw fixation represents the gold standard for lumbar degenerative disc disease with instability. Although it is an established technique, it is nevertheless an invasive intervention with high complication rates. Therefore, minimally invasive approaches have been developed, the medialized bilateral screw pedicel fixation (mPACT) being one of them. The study objective is to evaluate prospectively the efficacy and safety of the mPACT technique compare ...[more]

PMID: 29463278

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Project description:BackgroundPedicle screw invasion of the proximal articular process will cause local articular process degeneration and acceleration, which is an important factor affecting adjacent segment degeneration. Although lumbar spondylolisthesis is a risk factor for screw invasion of the proximal joint, there is no clear conclusion regarding the two different types of spondylolisthesis. Therefore, the purpose of this study was to explore the influence of pedicle screw placement on proximal facet invasion in the treatment of degenerative spondylolisthesis and isthmic spondylolisthesis.MethodsIn total, 468 cases of lumbar spondylolisthesis treated by decompression and fusion in our hospital from January 2017 to January 2020 were included in this retrospective study. Among them, 238 cases were degenerative spondylolisthesis (group A), and 230 cases were isthmic spondylolisthesis (group B). Sex, age, body mass index, bone mineral density, preoperative visual analog scale (VAS) and Oswestry Disability Index (ODI) scores, postoperative VAS and ODI scores at 1 month and 3 months, and angle of the proximal facet joint at the last follow-up were recorded and compared between the two groups. The degree of pedicle screw invasion of the proximal facet joint was graded and compared by the SEO grading method.ResultsThere were no significant differences in sex, age, body mass index, bone mineral density, preoperative VAS and ODI scores, or proximal facet joint angle between the two groups (P > 0.05). There was no significant difference in VAS and ODI scores between the two groups at 1 month and 3 months after the operation (P > 0.05). The VAS score of group A at the last follow-up was 1 (1,2). The VAS score of group B at the last follow-up was 3 (1,3). The ODI score of group A at the last follow-up was 6(4,26). The ODI score of group B at the last follow-up was 15(8,36). The VAS and ODI scores of the two groups at the last follow-up were significantly different (P < 0.05). According to the SEO grading method, the invasion of the proximal articular process by pedicle screw placement in group A involved 320 cases in grade 0, 128 cases in grade I and 28 cases in grade II. In group B, there were 116 cases in grade 0, 248 cases in grade I and 96 cases in grade II, with a significant difference (P < 0.01).ConclusionIn summary, a certain number of cases involving screws invading the proximal facet joint occurred in the two different types of lumbar spondylolisthesis, but the number in the isthmic spondylolisthesis group was significantly higher than that in the degenerative spondylolisthesis group, which caused more trauma to the proximal facet joint and significantly affected the patient prognosis.

Project description:BackgroundFew reports to date have evaluated the effects of different pedicle screw insertion depths on sagittal balance and prognosis after posterior lumbar interbody and fusion (PLIF) in patients with lumbar degenerative spondylolisthesis (LDS).MethodsA total of 88 patients with single-level PLIF for LDS from January 2018 to December 2019 were enrolled. Long screw group (Group L): 52 patients underwent long pedicle screw fixation (the leading edge of the screw exceeded 80% of the anteroposterior diameter of vertebral body). Short screw group (Group S): 36 patients underwent short pedicle screw fixation (the leading edge of the screw was less than 60% of the anteroposterior diameter of vertebral body). Local deformity parameters of spondylolisthesis including slip degree (SD) and segment lordosis (SL), spino-pelvic sagittal plane parameters including pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS) and lumbar lordosis (LL), Oswestry Disability Index (ODI), and Visual Analog Scale (VAS) for back pain of both groups were compared. Postoperative complications, including vertebral fusion rate and screw loosening rate, were recorded.ResultsExcept that PI in Group S at the final follow-up was not statistically different from the preoperative value (P > 0.05), other parameters were significantly improved compared with preoperative values one month after surgery and at the final follow-up (P < 0.05). There was no significant difference in parameters between Group L and Group S before and one month after surgery (P > 0.05). At the final follow-up, SD, SL, LL, PT and PI-LL differed significantly between the two groups (P < 0.05). Compared with the preoperative results, ODI and VAS in both groups decreased significantly one month after surgery and at the final follow-up (P < 0.05). Significant differences of ODI and VAS were found between the two groups at the final follow-up (P < 0.05). Postoperative complications were not statistically significant between the two groups (P > 0.05).ConclusionsPLIF can significantly improve the prognosis of patients with LDS. In terms of outcomes with an average follow-up time of 2 years, the deeper the screw depth is within the safe range, the better the spino-pelvic sagittal balance may be restored and the better the quality of life may be.

Dataset Information

Clinical and radiological effect of medialized cortical bone trajectory for lumbar pedicle screw fixation in patients with degenerative lumbar spondylolisthesis: study protocol for a randomized controlled trial (mPACT).

Publications

Clinical and radiological effect of medialized cortical bone trajectory for lumbar pedicle screw fixation in patients with degenerative lumbar spondylolisthesis: study protocol for a randomized controlled trial (mPACT).

Similar Datasets

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