scholarly journals Use of Nitinol Rods for Lumbosacral Spine Fixation (Prospective Randomized Clinical Study)

2014 ◽  
Vol 21 (2) ◽  
pp. 19-24
Author(s):  
S. V Kolesov ◽  
V. V Shvets ◽  
D. A Kolobovskiy ◽  
A. I Kaz’min ◽  
N. S Morozova

One hundred thirty operations were performed in patients (57 males, 73 females) with degenerative lumbar spine diseases during the period from 2010 to 2012. Mean age of patients made up 57 (45-82) years. Depending on the type of intervention all patients were divided into 2 groups: in 60patients (1 st group) dynamic stabilization with nitinol rods without fusion and in 70patients (2 nd group) rigid fixation of lumbar spine with titanium rods was performed. Outcomes were analyzed in 1.5 years after surgery. VAS, ODI and SF36 questionnaires showed improvement of patients’ condition in both groups. Restoration of lordosis was from 22 to 35° and from 23 to 37° in 1 st and 2 nd groups, respectively. No screw instability, bone tissue resorption around the screws and adjacent segment pathology was noted in group 1. Functional X-rays showed preservation of mobility (5+1.2°). In 2 nd group formation of pseudarthrosis was recorded in 5patients, adjacent segment pathology - in 20 including 5 patients who required repeated surgical intervention. Transpedicular lumbosacral spine fixation using nitinol rods is an effective technique that enables to preserve movements in lumbosacral spine in combination with stable fixation

2019 ◽  
Vol 25 (2) ◽  
pp. 59-70
Author(s):  
S. V. Kolesov ◽  
A. I. Kazmin ◽  
V. V. Shvets ◽  
A. O. Gushcha ◽  
E. N. Poltorako ◽  
...  

Relevance. Surgical decompression and decompression with stabilization are highly effective for treatment of spinal canal stenosis at the level of lumbar spine. However, complications developing after application of rigid fixation systems resulted in active introduction of dynamic implants into clinical practice.Purpose of the study — to compare effectiveness of nitinol and titanium nails for lumbosacral fixation in surgical treatment of degenerative spine diseases.Materials and methods. 220 patients who underwent surgeries in 4 hospitals were randomized into two groups, each consisting of 110 patients (1:1 ratio): a group of patients who underwent stabilization of the vertebral motor segments with rods of nitinol with the required volume of decompression at the operation level and a group of patients who underwent stabilization of the vertebral motor segments with standard rods of titanium with the required volume of decompression at the intervention level. Patients suffered clinically significant spinal canal stenosis in one or two adjacent segments: from L3 to S1. Outcomes were evaluated during three years postoperatively by VAS scale for spine and lower limbs, and by ODI and SF-36 scales.Results. All scales demonstrated better values in both groups of patients, namely, significant decrease of pain syndrome and improvement in mental and physical health. X-ray examination of all patients during the study period demonstrated restoration of lumbar lordosis. Group of patients with dynamic nails featured less complications rate related to metal implants including adjacent segment disease.Conclusion. Transpedicular fixation of lumbosacral spine by nitinol nails is an effective technique allowing to preserve motion along with stable fixation.


2014 ◽  
Vol 60 (2) ◽  
pp. 151-155 ◽  
Author(s):  
Ricardo Vieira Botelho ◽  
Rafael Bastianello Junior ◽  
Luciana DiniGianini de Albuquerque ◽  
Wanderley Marques Bernardo

Objective: The objective of this review is to reveal the quality of published data and the effect size of DPFs compared to rigid fixation in lumbar spine. Summary of background data: since 2002, several dynamic pedicle fixation (DPF) systems have been developed with the aim to stabilize the spine without the undesirable effects of rigid lumbar spine fixation. Nearly ten years later, there are several studies on these dynamic systems. Methods: A systematic review was done in MEDLINE/PubMED, Embase, Cochrane Central Register of Randomized Trials and Google Scholar to assess the quality of published literature and the available studied outcomes in randomized controlled trials of DPF. Results: Only three papers described randomized trials studying DPF. One of them focused on protection of adjacent level disease provided by DPF. Conclusion: It was not possible to reveal any evidence for benefits using DPF compared to rigid fixation in surgery for lumbar spine.


Author(s):  
A. V. Spiridonov ◽  
Yu. Ya. Pestryakov ◽  
A. A. Kalinin ◽  
V. A. Byvaltsev

Introduction An increase in the load on adjacent segments causes changes in the parameters of the spinal-pelvic balance and, as a consequence, the development of the so-called biomechanical «stress». Such pressures are a key link in the pathogenesis of degeneration, and in the presence of clinical and neurological manifestations of the latter and adjacent segment degenerative disease (ASD/ASDd).Objective of this study was to assess the effect of the parameters of the spinal pelvic balance on the risk of developing ASD/ASDd after dorsal decompression-stabilizing interventions (DDSI).Material and Methods The study included medical records of patients who underwent DDSI for lumbar spine degenerative diseases. Clinical and instrumental parameters were assessed.Results Based on the inclusion criteria, 98 patients (48 with signs of ASD/ASDd and 50 without) were included in the study. The average postoperative follow-up period for the respondents was 46.6 ± 9.8 months. If PI/ LL parameters were <10 and the ratio of segmental and global lumbar lordosis (LIV-SI/LI-SI) was 50% or more, the incidence of ASD/ASDd was significantly lower in patients who underwent rigid lumbar stabilization surgery.Conclusion The values of PI/LL parameters and the ratio of segmental and global lumbar lordosis are obvious risk factors for the development of ASD/ASDd after rigid lumbar spine DDSI.


2012 ◽  
Vol 16 (3) ◽  
pp. 366-372
Author(s):  
Ahmet Karakasli ◽  
Berivan Cecen ◽  
Mehmet Erduran ◽  
Orcun Taylan ◽  
Onur Hapa ◽  
...  

Author(s):  
Moustafa Mesbah ◽  
Abdelwahed Barkaoui

Hybrid stabilization is widely performed for the surgical treatment of degenerative disk diseases. Pedicle-based hybrid stabilization intends to reduce fusion-associated drawbacks of adjacent segment degeneration, construct failure, and pseudoarthrosis. Recently, many types of pedicle-based hybrid stabilization systems have been developed and optimized, using polymeric devices as an adjunct for lumbar fusion procedures. Therefore, the purpose of this study was to evaluate the effect of new pedicle-based hybrid stabilization on bending stiffness and center of rotation at operated and adjacent levels in comparison with established semirigid and rigid devices in lumbar fusion procedures. A validated three-dimensional finite element model of the L3–S1 segments was modified to simulate postoperative changes during combined loading (moment of 7.5 N m + follower load of 400 N). Two models instrumented with pedicle-based hybrid stabilization (Dynesys Transition Optima, NFlex), semirigid system (polyetheretherketone), and rigid fixation system (titanium rod (Ti) were compared with those of the healthy and degenerated models. Contact force on the facet joint during extension increased in fusion (40 N) with an increase of bending stiffness in Dynesys and NFlex. The center of rotation shifted in posterior and cranial directions of the fused level. The centers of rotation in the lower lumbar spine is segment dependent and altered with the adopted construct. The bending stiffness was varied from 1.47 N m/° in lateral bending for the healthy model to 5.75 N m/° for the NFlex stabilization, which had the closest center of rotation, compared to the healthy center of rotation. Locations of center of rotation, stress, and strain distribution varied according to construct design and materials used. These data could help understand the biomechanical effects of current pedicle-based hybrid stabilization on the behavior of the lower lumbar spine.


2019 ◽  
Author(s):  
Markus R. Konieczny ◽  
Shejda Mokhaberi ◽  
Rüdiger Krauspe

We investigated if applying the Transition system (® Globus Medical) as topping off can prevent Adjacent Segment Degeneration (ASD) and if rate of ASD is increased if instrumentation stopped at the apex of the Lumbar Lordosis (LL). We enrolled 99 consecutive patients in a retrospective study who have been operated by instrumented fusion of the lumbar spine. Thirty patients were treated by topping of (Group 1), 69 patients received the standard procedure (Group 2). 18 patients of group 1 (60%) and 38 patients of group 2 (55%) developed ASD. The difference was not significant (p>0.05). In 17 patients (17%) instrumentation stopped at apex of LL. 14/17 patients (82%) developed an ASD. This influence was significant (p<0.05). Instrumented fusion of the lumbar spine should not stop at the apex of the lumbar curve. Topping off by hybrid dynamic fixation does not reduce the rate of ASD.


2010 ◽  
Vol 4 (1) ◽  
pp. 137-141 ◽  
Author(s):  
Ali Fahir Ozer ◽  
Neil R Crawford ◽  
Mehdi Sasani ◽  
Tunc Oktenoglu ◽  
Hakan Bozkus ◽  
...  

Background:A lumbar pedicular dynamic stabilization system (LPDSS) is an alternative to fusion for treatment of degenerative disc disease (DDD). In this study, clinical and radiological results of one LPDSS (Saphinaz, Medikon AS, Turkey) were compared with results of rigid fixation after two-year follow-up.Methods:All patients had anteroposterior and lateral standing x-rays of the lumbar spine preoperatively and at 3 months, 12 months and 24 months after surgery. Lordosis of the lumbar spine, segmental lordosis and ratio of the height of the intervertebral disc spaces (IVS) measured preoperatively and at 3 months, 12 months and 24 months after surgery.All patients underwent MRI and/or CT preoperatively, 3months, 12 months and 24 months postoperatively. The ratio of intervertebral disc space to vertebral body height (IVS) and segmental and lumbar lordosis were evaluated preoperatively and postoperatively. Pain scores were evaluatedviaVisual Analog Scale (VAS) and Oswestry Disability Index (ODI) preoperatively and postoperatively.Results:In both groups, the VAS and ODI scores decreased significantly from preoperatively to postoperatively. There was no difference in the scores between groups except that a lower VAS and ODI scores were observed after 3 months in the LPDSS group. In both groups, the IVS ratio remained unchanged between preoperative and postoperative conditions. The lumbar and segmental lordotic angles decreased insignificantly to preoperative levels in the months following surgery.Conclusions:Patients with LPDSS had equivalent relief of pain and maintenance of sagittal balance to patients with standard rigid screw-rod fixation. LPDSS appears to be a good alternative to rigid fixation.


2010 ◽  
Vol 4 (4) ◽  
pp. 579-584
Author(s):  
Prakit Tienboon ◽  
Nara Jaruwangsanti

Abstract Background: Adjacent segment disease (ASD) is a major complication following spinal instrumentation and fusion. The search for of the rod flexibility factors responsible for junctional degeneration is still ongoing. Objective: Determine the rod stiffness and ASD following posterior instrumentation and fusion for lumbar spine and find the proper rod diameter for adult spinal instrumentation for fusion. Subject and methods: Retrospective evaluation of all patients requiring spinal instrumentation to determine the different rod diameter that predispose toward junctional degeneration was completed. All patients requiring spinal instrumentation over a one-year period were studied retrospectively. One-hundred eight-seven patients (mean age 61.6 years) who had undergone decompression and fusion with pedicle screw instrumentation were evaluated. The average follow-up was 4.2 years. The average number of levels fused was 2.9 segments (range: 1-8). Adjacent spinal level pre- and post-operatively was determined on the plain X-rays. Junctional degeneration was defined as new episode of degeneration of the adjacent level on radiologic finding. Asymptomatic patients did not demonstrate junctional degeneration on the routine post-operative X-rays. Results: ASD developed in 15 (8.0%) out of 187 patients, including compression fractures (n=2), spinal stenosis (n=6), and symptomatic disc collapse (n=7). There was a close correlation between the posterior instrument stiffness and the development of ASD (p=0.011). For fusion and fixation with 5.5 mm and 6.0 mm rod diameter, ASD occurred in four (3.7%) out of 108 patients and in 11 (13.9 %) out of 79 patients, resepectively. The incidences of ASD were greater when the posterior instrument used were stiffer in lumbar spine fusion. The pre-operative age, gender, and indication for surgery were not associated with the development of ASD. Conclusion: The prevalence of symptomatic ASD relatively increased with increasing stiffness of spinal implant. The diameter of the longitudinal rod strongly affected the fixator loads, and influenced the stresses in the vertebral endplates. The rod diameter had influence on the stresses in the adjacent spinal motion segment.


2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Cédric Barrey ◽  
Gilles Perrin ◽  
Sabina Champain

Dynamic systems in the lumbar spine are believed to reduce main fusion drawbacks such as pseudarthrosis, bone rarefaction, and mechanical failure. Compared to fusion achieved with rigid constructs, biomechanical studies underlined some advantages of dynamic instrumentation including increased load sharing between the instrumentation and interbody bone graft and stresses reduction at bone-to-screw interface. These advantages may result in increased fusion rates, limitation of bone rarefaction, and reduction of mechanical complications with the ultimate objective to reduce reoperations rates. However published clinical evidence for dynamic systems remains limited. In addition to providing biomechanical evaluation of a pedicle-screw-based dynamic system, the present study offers a long-term (average 10.2 years) insight view of the clinical outcomes of 18 patients treated by fusion with dynamic systems for degenerative lumbar spine diseases. The findings outline significant and stable symptoms relief, absence of implant-related complications, no revision surgery, and few adjacent segment degenerative changes. In spite of sample limitations, this is the first long-term report of outcomes of dynamic fusion that opens an interesting perspective for clinical outcomes of dynamic systems that need to be explored at larger scale.


2021 ◽  
Vol 23 (1) ◽  
pp. 47-61
Author(s):  
V. S. Klimov ◽  
A. V. Evsyukov ◽  
R. V. Khalepa ◽  
S. O. Ryabykh ◽  
E. V. Amelina ◽  
...  

The study objective is to study the causes of repeated surgical treatment in patients of an older age group with degenerative pathology of the lumbar spine.Materials and methods. A retrospective analysis of the treatment of 962 patients who underwent surgical treatment of degenerative pathology on the basis of the FCN of Novosibirsk from 2013 to 2017. A total of 360 men, 602 women; average age 66 years. 624 (64.9 %) patients underwent decompression, 338 patients (35.1 %) underwent stabilizing intervention in combination with decompression. The study group consisted of 98 (10.2 %) patients who underwent repeated operations taking into account the inclusion and exclusion criteria. On average, the period after the previous intervention is 17 months (from 1 day to 6 year). 68 patients (69.4 %) previously underwent decompression interventions, 30 (30.6 %) rigid stabilization. The indication for revision treatment was the presence of pain and (or) neurological deficiency, resistant to treatment for at least 6 weeks. Evaluation criteria are described, and the structure of complications is analyzed. The minimum follow-up period after repeated surgery was 1 year, the maximum 6 years.Results. Iatrogenic factors were detected in 39 patients (39.8 %). Progression of degenerative pathology in 59 (60.2 %) patients. More often, repeated intervention was performed at the level of L4–L5 (36.1 %), the cranial adjacent segment was 76.5 %, and the caudal segment was 23.5 %. The minimum period of manifestation of continued degeneration is 3 months. The development of the disease of the adjacent segment after fixation is higher in the period of 3–4 years (p = 0.015). Patients with repeated surgical treatment after decompression for continued degeneration had a higher BMI of 32.3 (p = 0.12), as well as patients with damage to the adjacent segment 32.5 (p = 0.10), compared with the group of primary patients (BMI 30.6 on average). The similar dependance is registered for patients after stabilization: BMI of patients with repeated interventions is 34.5 that is higher than BMI of primary interventions group (on average 33.2, р = 0.13).Conclusions. The main reason for repeated interventions in patients of an older age group is the progression of degenerative pathology on the segments on the segment operated as as well as the adjacent segments (60.2 % repeated interventions, 46.9 % at the adjacent level including).Repeated surgical treatment of patients of an older age group in the early period (for up to 1 year) is most often due to insufficiently effective primary surgical intervention with prevailing early recurrence of disk herniation (1.6 % patients of total number of primarily operated). In the long term (more than 3 years), the reason for repeated surgical treatment is due to the development of an adjacent segment disease where the number of operations of patients with primarily made rigid fixation is increasing progressively in the course of time.High BMI is a predictor of the development of instability of the vertebral motor segment and continued degeneration of the operated one as well as the adjacent level in the long follow-up time.


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