A Study to Compare the Efficacy of a Biodegradable Dynamic Fixation System With Titanium Devices in Posterior Spinal Fusion Between Articular Processes in a Canine Model

2020 ◽  
Vol 143 (3) ◽  
Author(s):  
Tailong Yu ◽  
Leyu Zheng ◽  
Guanghua Chen ◽  
Nanxiang Wang ◽  
Xiaoyan Wang ◽  
...  
Keyword(s):  
Lumbar Fusion ◽  
Biomechanical Analysis ◽  
Adjacent Segment ◽  
Rigid Fixation ◽  
Initial Shape ◽  
Posterior Lumbar Fusion ◽  
Dynamic Fixation ◽  
Flexion Extension ◽  
Biomechanical Tests ◽  
Fixation System

Abstract The objective of this study was to apply a biodegradable dynamic fixation system (BDFS) for lumbar fusion between articular processes and compare the fusion results and biomechanical changes with those of conventional rigid fixation. Twenty-four mongrel dogs were randomly assigned to 2 groups and subjected to either posterior lumbar fusion surgery with a BDFS or titanium rods (TRs) at the L5–L6 segments. Six animals in each group were sacrificed at 8 or 16 weeks. Fusion conditions were evaluated by computed tomography (CT), manual palpation, biomechanical tests, and histological analysis. Biomechanical tests were performed at the L4–7 (for range of motion (ROM)) and L5–6 (for fusion stiffness) segments. Histological examination was performed on organs, surrounding tissues, and the fused area. The magnesium alloy components maintained their initial shape 8 weeks after the operation, but the meshing teeth were almost completely degraded at 16 weeks. The biomechanical analysis revealed an increased lateral bending ROM at 8 weeks and axial torsion ROM at 16 weeks. The L4–5 extension–flexion ROMs in the BDFS group were 2.29 ± 0.86 deg and 3.17 ± 1.08 deg at 16 weeks, respectively, compared with 3.22 ± 0.56 deg and 5.55 ± 1.84 deg in TR group. However, both groups showed similar fusion results. The BDFS design is suitable, and its degradation in vivo is safe. The BDFS can be applied for posterior lumbar fusion between articular processes to complete the fusion well. Additionally, the BDFS can reduce the decline in lateral motion and hypermotion of the cranial adjacent segment in flexion–extension motion.

A novel dynamic fixation system with biodegradable components on lumbar fusion between articular processes in a canine model

2020 ◽  
Vol 234 (7) ◽  
pp. 738-748
Author(s):  
Tailong Yu ◽  
Leyu Zheng ◽  
Guanghua Chen ◽  
Xiaoyan Wang ◽  
Hui Chi ◽  
...  
Keyword(s):  
Magnesium Alloy ◽  
Lumbar Fusion ◽  
Rigid Fixation ◽  
The Novel ◽  
Initial Shape ◽  
Posterior Lumbar Fusion ◽  
Dynamic Fixation ◽  
Manual Palpation ◽  
Biomechanical Changes ◽  
Fixation System

The objective of this study was to design a novel dynamic fixation system with biodegradable components, apply it for lumbar fusion between articular processes and compare the fusion results and biomechanical changes to those of conventional rigid fixation. The novel dynamic fixation system was designed using a finite element model, stress distributions were compared and 24 mongrel dogs were randomly assigned to two groups and subjected to either posterior lumbar fusion surgery with a novel dynamic fixation system or titanium rods at the L5-L6 segments. Lumbar spines were assessed in both groups to detect radiographic, manual palpation and biomechanical changes. Histological examination was performed on organs and surrounding tissues. In the novel dynamic fixation system, stress was mainly distributed on the meshing teeth of the magnesium alloy spacer. The magnesium alloy components maintained their initial shape 8 weeks after the operation, but the meshing teeth were almost completely degraded at 16 weeks. The novel dynamic fixation system revealed an increased lateral bending range of motion at 8 weeks; however, both groups showed similar radiographic grades, fusion stiffness, manual palpation and histological results. The novel dynamic fixation system design is suitable, and its degradation in vivo is safe. The novel dynamic fixation system can be applied for posterior lumbar fusion between articular processes and complete the fusion like titanium rods.

Adjacent-segment effects of lumbar cortical screw–rod fixation versus pedicle screw–rod fixation with and without interbody support

2021 ◽  
pp. 1-7
Author(s):  
Piyanat Wangsawatwong ◽  
Anna G. U. Sawa ◽  
Bernardo de Andrada Pereira ◽  
Jennifer N. Lehrman ◽  
Luke K. O’Neill ◽  
...  
Keyword(s):  
Pedicle Screw ◽  
Interbody Fusion ◽  
Lumbar Fusion ◽  
Statistical Significance ◽  
Adjacent Segment ◽  
Lumbar Interbody Fusion ◽  
Lateral Bending ◽  
Single Level ◽  
Cortical Screw ◽  
Flexion Extension

OBJECTIVE Cortical screw–rod (CSR) fixation has emerged as an alternative to the traditional pedicle screw–rod (PSR) fixation for posterior lumbar fixation. Previous studies have concluded that CSR provides the same stability in cadaveric specimens as PSR and is comparable in clinical outcomes. However, recent clinical studies reported a lower incidence of radiographic and symptomatic adjacent-segment degeneration with CSR. No biomechanical study to date has focused on how the adjacent-segment mobility of these two constructs compares. This study aimed to investigate adjacent-segment mobility of CSR and PSR fixation, with and without interbody support (lateral lumbar interbody fusion [LLIF] or transforaminal lumbar interbody fusion [TLIF]). METHODS A retroactive analysis was done using normalized range of motion (ROM) data at levels adjacent to single-level (L3–4) bilateral screw–rod fixation using pedicle or cortical screws, with and without LLIF or TLIF. Intact and instrumented specimens (n = 28, all L2–5) were tested using pure moment loads (7.5 Nm) in flexion, extension, lateral bending, and axial rotation. Adjacent-segment ROM data were normalized to intact ROM data. Statistical comparisons of adjacent-segment normalized ROM between two of the groups (PSR followed by PSR+TLIF [n = 7] and CSR followed by CSR+TLIF [n = 7]) were performed using 2-way ANOVA with replication. Statistical comparisons among four of the groups (PSR+TLIF [n = 7], PSR+LLIF [n = 7], CSR+TLIF [n = 7], and CSR+LLIF [n = 7]) were made using 2-way ANOVA without replication. Statistical significance was set at p < 0.05. RESULTS Proximal adjacent-segment normalized ROM was significantly larger with PSR than CSR during flexion-extension regardless of TLIF (p = 0.02), or with either TLIF or LLIF (p = 0.04). During lateral bending with TLIF, the distal adjacent-segment normalized ROM was significantly larger with PSR than CSR (p < 0.001). Moreover, regardless of the types of screw-rod fixations (CSR or PSR), TLIF had a significantly larger normalized ROM than LLIF in all directions at both proximal and distal adjacent segments (p ≤ 0.04). CONCLUSIONS The use of PSR versus CSR during single-level lumbar fusion can significantly affect mobility at the adjacent segment, regardless of the presence of TLIF or with either TLIF or LLIF. Moreover, the type of interbody support also had a significant effect on adjacent-segment mobility.

scholarly journals Differences in standing and sitting spinopelvic sagittal alignment for patients with posterior lumbar fusion: important considerations for the changes of unfused adjacent segments lordosis

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhuoran Sun ◽  
Siyu Zhou ◽  
Wei Wang ◽  
Da Zou ◽  
Weishi Li
Keyword(s):  
Sagittal Alignment ◽  
Lumbar Fusion ◽  
Linear Regression Analysis ◽  
Posterior Lumbar Interbody Fusion ◽  
Sagittal Profile ◽  
Adjacent Segment ◽  
Sitting Position ◽  
Lumbosacral Fusion ◽  
Posterior Lumbar Fusion

Abstract Objective This study aimed to describe the changes in spinopelvic sagittal alignment in the sitting position after posterior lumbar fusion, and to identify the factors influencing unfused adjacent segment lordosis. Methods Consecutive patients with lumbar degenerative disease who underwent posterior lumbar interbody fusion between December 2010 and April 2012 were recruited. Lateral full spine radiographs were obtained in the standing, erect sitting, and natural sitting positions. Spinopelvic parameters were measured preoperatively and at the final follow-up. Results The data of 63 patients were analyzed in this study. The average age was 61.6 ± 11.0 years. When changing from standing to sitting at the final follow-up, all spinopelvic sagittal parameters with the exceptions of pelvic incidence and thoracic kyphosis were significantly altered. The most noticeable changes occurred in the natural sitting position, with the spine slumped toward achieving a C-shaped sagittal profile. Multiple linear regression analysis revealed that when changing to a natural sitting position, age and fusion levels reflected the changes in lumbar lordosis (ΔLL), age and lumbosacral fusion reflected the changes in upper residual lordosis (ΔURL). Conclusion The most noticeable changes in spinopelvic sagittal alignment occurred in the natural sitting position after lumbar fusion. Age, fusion levels, and lumbosacral fusion significantly influenced the differences in LL and URL between the standing and natural sitting position. These characteristics should be fully considered when planning spinal realignment surgery and investigating the etiological factors of junctional complications.

Treatment of lumbar spinal stenosis with a total posterior arthroplasty prosthesis: implant description, surgical technique, and a prospective report on 29 patients

2007 ◽  
Vol 22 (1) ◽  
pp. 1-11 ◽  
Author(s):  
Paul McAfee ◽  
Larry T. Khoo ◽  
Luiz Pimenta ◽  
Andy Capuccino ◽  
Domagoj Coric ◽  
...  
Keyword(s):  
Spinal Stenosis ◽  
Short Form ◽  
Lumbar Fusion ◽  
Degenerative Spondylolisthesis ◽  
Adjacent Segment ◽  
Surgical Morbidity ◽  
Flexion Extension ◽  
Surgical Data ◽  
The Mean ◽  
Facet Arthropathy

Object Total disc replacement is an alternative to lumbar fusion, but patients with spinal stenosis, spondylolisthesis, and facet arthropathy are often excluded from this procedure because increased adjacent-segment motion can exacerbate dorsal spondylotic changes. In such cases of degenerative spondylolisthesis with stenosis, decompression and fusion remain the gold standard of treatment. To avoid attendant loss of motion at the treated segment, the TOPS system is a novel total posterior arthroplasty prosthesis that allows for an alternative dynamic, multiaxial, three-column stabilization and motion preservation. The purpose of this study is to report preliminary surgical data and clinical outcomes in patients treated with the TOPS lumbar total posterior arthroplasty system. Methods Twenty-nine patients were enrolled in a nonrandomized, multicenter, prospective pilot study outside the US. All patients had spinal stenosis and/or spondylolisthesis at L4–5 due to facet arthropathy. Radiographs and scores on outcome measures including the visual analog scale (VAS) for pain, Oswestry Disability Index (ODI), Short Form-36, and Zurich Claudication Questionnaire were prospectively recorded before surgery and at 6-week, 3-month, 6-month, and 1-year intervals after surgery. Prior to instrumentation, a bilateral total facetectomy and laminectomy at L4–5 or L3–4 was performed via a standard midline posterior approach. After decompression, the TOPS screws were inserted into four pedicles to achieve maximal purchase with triangulating bicortical trajectories. An appropriately sized TOPS arthroplasty implant was then applied. The mean surgical time was 3.1 hours, and patients' clinical status improved significantly following treatment with the TOPS device. The mean ODI score decreased compared with baseline by 41% at 1 year, and the 100-mm VAS score declined by 76 mm over the same time period. Radiographic analysis showed that lumbar motion was maintained, disc height was preserved, and no evidence of screw loosening was found. No device malfunctions or migrations and no device-related adverse events were reported during the study. Conclusions The TOPS total posterior arthroplasty system represents a novel, dynamic, posterior arthroplasty device that provides multiaxial stability in flexion, extension, rotation, and lateral bending after total facetectomy and neural decompression. The surgical data indicate that it can be safely applied via a traditional approach with low surgical morbidity and excellent 1-year functional and radiographic outcomes in patients with degenerative spondylolisthesis accompanied by stenosis and back pain.

Biomechanical Assessment of a PEEK Rod System for Semi-Rigid Fixation of Lumbar Fusion Constructs

2011 ◽  
Vol 133 (8) ◽  
Author(s):  
Matthew F. Gornet ◽  
Frank W. Chan ◽  
John C. Coleman ◽  
Brian Murrell ◽  
Russ P. Nockels ◽  
...  
Keyword(s):  
Lumbar Fusion ◽  
Dynamic Performance ◽  
Load Sharing ◽  
Axial Rotation ◽  
Rigid Fixation ◽  
Peek Rods ◽  
Significant Difference ◽  
Flexion Extension ◽  
Rod System

The concept of semi-rigid fixation (SRF) has driven the development of spinal implants that utilize nonmetallic materials and novel rod geometries in an effort to promote fusion via a balance of stability, intra- and inter-level load sharing, and durability. The purpose of this study was to characterize the mechanical and biomechanical properties of a pedicle screw-based polyetheretherketone (PEEK) SRF system for the lumbar spine to compare its kinematic, structural, and durability performance profile against that of traditional lumbar fusion systems. Performance of the SRF system was characterized using a validated spectrum of experimental, computational, and in vitro testing. Finite element models were first used to optimize the size and shape of the polymeric rods and bound their performance parameters. Subsequently, benchtop tests determined the static and dynamic performance threshold of PEEK rods in relevant loading modes (flexion-extension (F/E), axial rotation (AR), and lateral bending (LB)). Numerical analyses evaluated the amount of anteroposterior column load sharing provided by both metallic and PEEK rods. Finally, a cadaveric spine simulator was used to determine the level of stability that PEEK rods provide. Under physiological loading conditions, a 6.35 mm nominal diameter oval PEEK rod construct unloads the bone-screw interface and increases anterior column load (approx. 75% anterior, 25% posterior) when compared to titanium (Ti) rod constructs. The PEEK construct’s stiffness demonstrated a value lower than that of all the metallic rod systems, regardless of diameter or metallic composition (78% < 5.5 mm Ti; 66% < 4.5 mm Ti; 38% < 3.6 mm Ti). The endurance limit of the PEEK construct was comparable to that of clinically successful metallic rod systems (135N at 5 × 106 cycles). Compared to the intact state, cadaveric spines implanted with PEEK constructs demonstrated a significant reduction of range of motion in all three loading directions (> 80% reduction in F/E, p < 0.001; > 70% reduction in LB, p < 0.001; > 54% reduction in AR, p < 0.001). There was no statistically significant difference in the stability provided by the PEEK rods and titanium rods in any mode (p = 0.769 for F/E; p = 0.085 for LB; p = 0.633 for AR). The CD HORIZON® LEGACY™ PEEK Rod System provided intervertebral stability comparable to currently marketed titanium lumbar fusion constructs. PEEK rods also more closely approximated the physiologic anteroposterior column load sharing compared to results with titanium rods. The durability, stability, strength, and biomechanical profile of PEEK rods were demonstrated and the potential advantages of SRF were highlighted.

Treatment of lumbar spinal stenosis with a total posterior arthroplasty prosthesis: implant description, surgical technique, and a prospective report on 29 patients

2007 ◽  
Vol 22 (1) ◽  
pp. 1-11 ◽  
Author(s):  
Paul McAfee ◽  
Larry T. Khoo ◽  
Luiz Pimenta ◽  
Andy Capuccino ◽  
Domagoj Coric ◽  
...  
Keyword(s):  
Spinal Stenosis ◽  
Short Form ◽  
Lumbar Fusion ◽  
Degenerative Spondylolisthesis ◽  
Adjacent Segment ◽  
Surgical Morbidity ◽  
Flexion Extension ◽  
Surgical Data ◽  
The Mean ◽  
Facet Arthropathy

Object Total disc replacement is an alternative to lumbar fusion, but patients with spinal stenosis, spondylolisthesis, and facet arthropathy are often excluded from this procedure because increased adjacent-segment motion can exacerbate dorsal spondylotic changes. In such cases of degenerative spondylolisthesis with stenosis, decompression and fusion remain the gold standard of treatment. To avoid attendant loss of motion at the treated segment, the TOPS system is a novel total posterior arthroplasty prosthesis that allows for an alternative dynamic, multiaxial, three-column stabilization and motion preservation. The purpose of this study is to report preliminary surgical data and clinical outcomes in patients treated with the TOPS lumbar total posterior arthroplasty system. Methods Twenty-nine patients were enrolled in a nonrandomized, multicenter, prospective pilot study outside the US. All patients had spinal stenosis and/or spondylolisthesis at L4–5 due to facet arthropathy. Radiographs and scores on outcome measures including the visual analog scale (VAS) for pain, Oswestry Disability Index (ODI), Short Form-36, and Zurich Claudication Questionnaire were prospectively recorded before surgery and at 6-week, 3-month, 6-month, and 1-year intervals after surgery. Prior to instrumentation, a bilateral total facetectomy and laminectomy at L4–5 or L3–4 was performed via a standard midline posterior approach. After decompression, the TOPS screws were inserted into four pedicles to achieve maximal purchase with triangulating bicortical trajectories. An appropriately sized TOPS arthroplasty implant was then applied. The mean surgical time was 3.1 hours, and patients' clinical status improved significantly following treatment with the TOPS device. The mean ODI score decreased compared with baseline by 41% at 1 year, and the 100-mm VAS score declined by 76 mm over the same time period. Radiographic analysis showed that lumbar motion was maintained, disc height was preserved, and no evidence of screw loosening was found. No device malfunctions or migrations and no device-related adverse events were reported during the study. Conclusions The TOPS total posterior arthroplasty system represents a novel, dynamic, posterior arthroplasty device that provides multiaxial stability in flexion, extension, rotation, and lateral bending after total facetectomy and neural decompression. The surgical data indicate that it can be safely applied via a traditional approach with low surgical morbidity and excellent 1-year functional and radiographic outcomes in patients with degenerative spondylolisthesis accompanied by stenosis and back pain.

scholarly journals Biomechanical Evaluation of strategies for Adjacent Segment Disease after Lateral lumbar interbody fusion: is extension of pedicle screw necessary?

2019 ◽  
Author(s):  
Ziyang Liang ◽  
Jianchao Cui ◽  
Jiarui Zhang ◽  
Jiahui He ◽  
Jingjing Tang ◽  
...  
Keyword(s):  
Pedicle Screw ◽  
Interbody Fusion ◽  
Adjacent Segment Disease ◽  
Adjacent Segment ◽  
Fe Model ◽  
Rigid Fixation ◽  
Lateral Bending ◽  
Maximum Displacement ◽  
Flexion Extension ◽  
Posterior Extension

Abstract Background: Adjacent segment disease (ASD) is a well-known complication after interbody fusion. Pedicle screw-rod revision possessed sufficient strength and rigidity. However, is a surgical segment with rigid fixation necessary for ASD reoperation? This study aimed to investigate the biomechanical effect on LLIF with different instrumentation for ASD treatment.Methods: A validated L2~5 finite element (FE) model was modified to simulate. ASD was considered the level cranial to the upper-instrumented segment(L3/4). Bonegraft fusion in LLIF with bilateral pedicle screw fixation (BPS) has occurred at the L4/5. The ASD segment for each group was underwent a) LLIF + posterior extension of BPS, b) PLIF + posterior extension of BPS, c) LLIF + lateral screw, d) Stand-alone LLIF. L3/4 Range of motion (ROM), interbody cage stress and strain, screw-boneinterface stress, cage-endplate interface stress, and L2/3 nucleus pulposus of intradiscal pressure (NP-IDP) analysis were calculated for the comparisons among fourmodels.Results: All reconstructive models displayed decreased motion at L3/4. In each loading condition, difference was not significant between model a and b, which providedthe maximum ROM reduction (73.8% to 97.7%, 68.3% to 98.4%, respectively). Model c also provided a significant ROM reduction (64.9% to 77.5%). Model d provided a minimal restriction of ROM (18.3% to 90.1%), which exceeded that of model a by 13.1 times in flexion-extension, 10.3 times in lateral bending and 4.8 times in rotation. Model b generated greater cage stress than other models, particularly in flexion. The maximum displacement of the cage and the peak stress of cage-endplate interface were found to be the highest in the model d in all loading conditions. For the screw bone interface, the stress was significantly greater in lateral instrumentation than that of posterior instrumentation.Conclusions: Stand-alone LLIF is likely to have limited stability, particularly in lateral bending and axial rotation. Posterior extension of BPS can provide the reliablystability and excellently protective effect on instrumentation and endplate. However, LLIF with in situ screw may be an alternative for ASD reoperation.

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