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Keywords = lumbar implant system

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16 pages, 829 KB  
Article
Evaluating the Efficacy of a Novel Titanium Cage System in ALIF and LLIF: A Retrospective Clinical and Radiographic Analysis
by Ryan W. Turlip, Mert Marcel Dagli, Richard J. Chung, Daksh Chauhan, Richelle J. Kim, Julia Kincaid, Hasan S. Ahmad, Yohannes Ghenbot and Jang Won Yoon
J. Clin. Med. 2025, 14(16), 5814; https://doi.org/10.3390/jcm14165814 - 17 Aug 2025
Viewed by 1122
Abstract
Background/Objectives: The success of lumbar interbody fusion depends on the implant design and the surgical approach used. This study evaluated the clinical and radiographic outcomes of lateral lumbar interbody fusion (LLIF) and anterior lumbar interbody fusion (ALIF) using a 3D-printed porous titanium [...] Read more.
Background/Objectives: The success of lumbar interbody fusion depends on the implant design and the surgical approach used. This study evaluated the clinical and radiographic outcomes of lateral lumbar interbody fusion (LLIF) and anterior lumbar interbody fusion (ALIF) using a 3D-printed porous titanium interbody cage system. Methods: A retrospective, single-center review of 48 patients treated for degenerative lumbar spine disease was conducted. Patients underwent LLIF, ALIF, or a combination of both using a 3D-printed titanium cage system (J&J MedTech, Raynham, MA, USA). The Oswestry disability index (ODI) and Patient-Reported Outcomes Measurement Information System (PROMIS) metrics were assessed after 6 weeks, 3 months, 6 months, and 12 months. Linear mixed-effects models evaluated the pre- and post-operative differences. Fusion performance and complications were assessed using the Bridwell grading system over 24 months. Results: A total of 78 levels (62 LLIF and 16 ALIF) were analyzed. Fusion rates were 90.3% (56/62) for LLIF levels and 81.3% (13/16) for ALIF levels by the end of 12 months. ODI scores improved significantly after 3 months (MD −13.0, p < 0.001), 6 months (MD −12.3, p < 0.001), and 12 months (MD −14.9, p < 0.001). PROMIS Pain Interference scores improved after 3 months (MD −6.1, p < 0.001), 6 months (MD −3.4, p < 0.001), and 12 months (MD −5.8, p < 0.001). PROMIS Physical Function scores improved after 3 months (MD +3.4, p = 0.032) and 12 months (MD +4.9, p < 0.001). Conclusions: This novel interbody cage demonstrated high fusion rates, significant pain and function improvements, and a favorable safety profile, warranting further comparative studies. Full article
(This article belongs to the Special Issue Clinical Advances in Spinal Neurosurgery)
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10 pages, 894 KB  
Article
High Fusion Rates with Structured Titanium TLIF Cages: A Retrospective 1-Year Study with and Without Adjacent Level Dynamic Stabilization
by Sonja Häckel, Jessica Gaff, Alana Celenza, Gregory Cunningham, Michael Kern, Paul Taylor and Andrew Miles
Surgeries 2025, 6(3), 52; https://doi.org/10.3390/surgeries6030052 - 30 Jun 2025
Viewed by 2693
Abstract
Background: Structured titanium (ST) cages are designed to enhance osseointegration and fusion in lumbar interbody procedures. However, clinical and radiological outcomes following TLIF using ST cages—particularly with or without adjacent-level dynamic stabilization (DSS)—have not been widely reported. Objective: To evaluate 12-month [...] Read more.
Background: Structured titanium (ST) cages are designed to enhance osseointegration and fusion in lumbar interbody procedures. However, clinical and radiological outcomes following TLIF using ST cages—particularly with or without adjacent-level dynamic stabilization (DSS)—have not been widely reported. Objective: To evaluate 12-month fusion outcomes and patient-reported outcomes (PROMs) after TLIF with structured titanium cages, comparing cases with and without adjacent-level DSS. Methods: In this retrospective cohort study, 82 patients undergoing TLIF with ST cages were analyzed—41 with hybrid instrumentation (TLIF + DSS) and 41 with TLIF alone. PROMs (ODI, VAS for back and leg pain, EQ-5D-5L) were assessed preoperatively and at 12 months. Fusion was assessed via CT scans at 12 months. Results: PROMs significantly improved over time in both groups (p < 0.001 for ODI, VAS back, VAS leg), but there were no significant differences between the hybrid and non-hybrid groups. Overall, the interbody fusion rate was 84%. Complete fusion was observed in 84% of the hybrid group and 80% of the TLIF-only group (p = 0.716), with very low rates of non-union. Conclusions: Structured titanium cages demonstrated excellent 1-year fusion rates and supported significant clinical improvement after TLIF. The addition of dynamic stabilization had no measurable effect on patient-reported or radiological outcomes at 12 months. Long-term studies are needed to assess any potential effect of DSS on adjacent segment disease. Full article
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11 pages, 6575 KB  
Article
High Accuracy of Three-Dimensional Navigated Kirschner-Wire-Less Single-Step Pedicle Screw System (SSPSS) in Lumbar Fusions: Comparison of Intraoperatively Planned versus Final Screw Position
by Mateusz Bielecki, Blake I. Boadi, Yizhou Xie, Chibuikem A. Ikwuegbuenyi, Minaam Farooq, Jessica Berger, Alan Hernández-Hernández, Ibrahim Hussain and Roger Härtl
Brain Sci. 2024, 14(9), 873; https://doi.org/10.3390/brainsci14090873 - 29 Aug 2024
Viewed by 2205
Abstract
(1) Background: Our team has previously introduced the Single-Step Pedicle Screw System (SSPSS), which eliminates the need for K-wires, as a safe and effective method for percutaneous minimally invasive spine (MIS) pedicle screw placement. Despite this, there are ongoing concerns about the reliability [...] Read more.
(1) Background: Our team has previously introduced the Single-Step Pedicle Screw System (SSPSS), which eliminates the need for K-wires, as a safe and effective method for percutaneous minimally invasive spine (MIS) pedicle screw placement. Despite this, there are ongoing concerns about the reliability and accuracy of screw placement in MIS procedures without traditional tools like K-wires and Jamshidi needles. To address these concerns, we evaluated the accuracy of the SSPSS workflow by comparing the planned intraoperative screw trajectories with the final screw positions. Traditionally, screw placement accuracy has been assessed by grading the final screw position using postoperative CT scans. (2) Methods: We conducted a retrospective review of patients who underwent lumbar interbody fusion, using intraoperative 3D navigation for screw placement. The planned screw trajectories were saved in the navigation system during each procedure, and postoperative CT scans were used to evaluate the implanted screws. Accuracy was assessed by comparing the Gertzbein and Robbins classification scores of the planned trajectories and the final screw positions. Accuracy was defined as a final screw position matching the classification of the planned trajectory. (3) Results: Out of 206 screws, 196 (95%) were accurately placed, with no recorded complications. (4) Conclusions: The SSPSS workflow, even without K-wires and other traditional instruments, facilitates accurate and reliable pedicle screw placement. Full article
(This article belongs to the Special Issue Advanced Clinical Technologies in Treating Neurosurgical Diseases)
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18 pages, 6689 KB  
Article
Experimental Analysis of Stress Shielding Effects in Screw Spacers Placed in Porcine Spinal Tissue
by Elliot Alonso Alcántara-Arreola, Karla Nayeli Silva-Garcés, Jocabed Mendoza-Martínez, Miguel Antonio Cardoso-Palomares and Christopher René Torres-SanMiguel
J. Funct. Biomater. 2024, 15(8), 238; https://doi.org/10.3390/jfb15080238 - 22 Aug 2024
Cited by 5 | Viewed by 2226
Abstract
Bone cortical tissues reorganize and remodel in response to tensile forces acting on them, while compressive forces cause atrophy. However, implants support most of the payload. Bones do not regenerate, and stress shielding occurs. The aim is to analyze the biomechanical behavior of [...] Read more.
Bone cortical tissues reorganize and remodel in response to tensile forces acting on them, while compressive forces cause atrophy. However, implants support most of the payload. Bones do not regenerate, and stress shielding occurs. The aim is to analyze the biomechanical behavior of a lumbar cage to study the implant’s stress shielding. The ASTM E-9 standard was used with the necessary adjustments to perform compression tests on lumbar and thoracic porcine spinal vertebrae. Twelve cases were analyzed: six with the metal prosthesis and six with the PEEK implant. A mathematical model based on the Hertz contact theory is proposed to assess the stress shielding for endoprosthesis used in spine pathologies. The lumbar spacer (screw) helps to reduce the stress shielding effect due to the ACME thread. The best interspinous spacer is the PEEK screw. It does not embed in bone. The deformation capability increases by 11.5% and supports 78.6 kg more than a system without any interspinous spacer. Full article
(This article belongs to the Special Issue Biomaterials and Biomechanics Studies in Tissue Engineering)
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11 pages, 514 KB  
Article
Cone Beam Computed Tomography Panoramic Mandibular Indices in the Screening of Postmenopausal Women with Low Bone Mass: Correlations with Bone Quantity and Quality
by Ioana Ruxandra Poiană, Iulia Florentina Burcea, Silviu-Mirel Pițuru and Alexandru Bucur
Dent. J. 2024, 12(8), 256; https://doi.org/10.3390/dj12080256 - 14 Aug 2024
Cited by 1 | Viewed by 1858
Abstract
Objective. This study examined the potential use of computed tomography panoramic mandibular indices on cone beam CT (CBCT) for assessing bone density in postmenopausal women with low bone mass. Study design. The study enrolled 104 postmenopausal women who underwent dual-energy X-ray absorptiometry (DXA) [...] Read more.
Objective. This study examined the potential use of computed tomography panoramic mandibular indices on cone beam CT (CBCT) for assessing bone density in postmenopausal women with low bone mass. Study design. The study enrolled 104 postmenopausal women who underwent dual-energy X-ray absorptiometry (DXA) using a DXA scanner and mental foramen region CBCT alongside the NewTom VGi EVO Cone Beam 3D system. We assessed the relationship between the following DXA parameters: lumbar, femoral neck, and total hip T score, bone mineral density (BMD), and lumbar trabecular bone score (TBS). The following panoramic mandibular indices were also considered: the computed tomography mandibular index superior (CTI(S)), computed tomography mandibular index inferior (CTI(I)), and computed tomography mental index (CTMI). Results. The study revealed moderate correlations between CBCT indices and BMD/TBS scores: CTMI showed the highest correlation with the femoral neck T-score (r = 0.551, p < 0.0001). TBS scores were also moderately correlated with CBCT indices: CTMI showed a moderate positive correlation with TBS (r = 0.431, p < 0.0001); CTI(S) had a similar moderate positive correlation with TBS (r = 0.421, p < 0.0001). AUC values ranged from 0.697 to 0.733 for osteoporosis versus the osteopenia/normal group and from 0.734 to 0.744 for low versus normal bone quality groups, p < 0.0001. The comparison of the values of the studied indices between low versus normal bone quality (quantified with TBS) groups showed high sensitivity but low specificity. Conclusions. CBCT-measured indices CTI(S), CTI(I), and CTMI are useful in assessing patients with low bone mass to improve, by specific treatment, the prognosis of dental implants. Full article
(This article belongs to the Special Issue Risk Factors in Implantology)
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22 pages, 4033 KB  
Review
The Impact of Navigation in Lumbar Spine Surgery: A Study of Historical Aspects, Current Techniques and Future Directions
by Ahmed Majid Heydar, Masato Tanaka, Shrinivas P. Prabhu, Tadashi Komatsubara, Shinya Arataki, Shogo Yashiro, Akihiro Kanamaru, Kazumasa Nanba, Hongfei Xiang and Huynh Kim Hieu
J. Clin. Med. 2024, 13(16), 4663; https://doi.org/10.3390/jcm13164663 - 8 Aug 2024
Cited by 14 | Viewed by 6072
Abstract
Background/Objectives: We sought to improve accuracy while minimizing radiation hazards, improving surgical outcomes, and preventing potential complications. Despite the increasing popularity of these systems, a limited number of papers have been published addressing the historical evolution, detailing the areas of use, and [...] Read more.
Background/Objectives: We sought to improve accuracy while minimizing radiation hazards, improving surgical outcomes, and preventing potential complications. Despite the increasing popularity of these systems, a limited number of papers have been published addressing the historical evolution, detailing the areas of use, and discussing the advantages and disadvantages, of this increasingly popular system in lumbar spine surgery. Our objective was to offer readers a concise overview of navigation system history in lumbar spine surgeries, the techniques involved, the advantages and disadvantages, and suggestions for future enhancements to the system. Methods: A comprehensive review of the literature was conducted, focusing on the development and implementation of navigation systems in lumbar spine surgeries. Our sources include PubMed-indexed peer-reviewed journals, clinical trial data, and case studies involving technologies such as computer-assisted surgery (CAS), image-guided surgery (IGS), and robotic-assisted systems. Results: To develop more practical, effective, and accurate navigation techniques for spine surgery, consistent advancements have been made over the past four decades. This technological progress began in the late 20th century and has since encompassed image-guided surgery, intraoperative imaging, advanced navigation combined with robotic assistance, and artificial intelligence. These technological advancements have significantly improved the accuracy of implant placement, reducing the risk of misplacement and related complications. Navigation has also been found to be particularly useful in tumor resection and minimally invasive surgery (MIS), where conventional anatomic landmarks are lacking or, in the case of MIS, not visible. Additionally, these innovations have led to shorter operative times, decreased radiation exposure for patients and surgical teams, and lower rates of reoperation. As navigation technology continues to evolve, future innovations are anticipated to further enhance the capabilities and accessibility of these systems, ultimately leading to improved patient outcomes in lumbar spine surgery. Conclusions: The initial limited utilization of navigation system in spine surgery has further expanded to encompass almost all fields of lumbar spine surgeries. As the cost-effectiveness and number of trained surgeons improve, a wider use of the system will be ensured so that the navigation system will be an indispensable tool in lumbar spine surgery. However, continued research and development, along with training programs for surgeons, are essential to fully realize the potential of these technologies in clinical practice. Full article
(This article belongs to the Special Issue Spine Surgery and Rehabilitation: Current Advances and Future Options)
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21 pages, 9977 KB  
Article
Radiological Outcomes of Magnetically Controlled Growing Rods for the Treatment of Children with Various Etiologies of Early-Onset Scoliosis—A Multicenter Study
by Pawel Grabala, Munish C. Gupta, Daniel E. Pereira, Michal Latalski, Anna Danielewicz, Pawel Glowka and Michal Grabala
J. Clin. Med. 2024, 13(6), 1529; https://doi.org/10.3390/jcm13061529 - 7 Mar 2024
Cited by 9 | Viewed by 2785
Abstract
Background: The management of spinal deformities diagnosed before the age of 10 is critical due to the child’s development, skeletal system, and growth mechanism. Magnetically controlled growing rods (MCGRs) are a surgical treatment option for the growing spine. The aim of this study [...] Read more.
Background: The management of spinal deformities diagnosed before the age of 10 is critical due to the child’s development, skeletal system, and growth mechanism. Magnetically controlled growing rods (MCGRs) are a surgical treatment option for the growing spine. The aim of this study was to analyze the radiological findings of patients treated with MCGRs for early-onset scoliosis (EOS) of various etiologies. We hypothesized that the MCGRs could provide acceptable long-term radiographic results, such as an increase in the T1–T12 and T1–S1 height and significant overall deformity correction. Methods: We retrospectively reviewed 161 EOS patients with a combined total of 302 MCGRs inserted at five institutions between 2016 and 2022 with a mean follow-up of at least two years. The Cobb angle of the major curve (MC), thoracic kyphosis (TK), lumbar lordosis (LL), and T1–T12 and T1–S1 height measurements were assessed before, after, and during the follow-up. Results: Among the 90 female and 71 male patients, there were 51 neurological, 42 syndromic, 58 idiopathic, and ten congenital scoliosis etiologies. Of the patients, 73 were aged under six years old. The mean follow-up time was 32.8 months. The mean age at placement of the MCGRs was 7 years and that at the last follow-up after fusion surgery was 14.5 years. The mean MC before the initial surgery was 86.2°; following rod implantation, it was 46.9°, and at the last follow-up visit, it was 45.8°. The mean correction rate among the etiology subgroups was from 43% to 50% at follow-up. The mean TK was noted as 47.2° before MCGR implantation, 47.1° after MCGR placement, and 44.5° at the last follow-up visit. The mean T1–T12 height increased by 5.95 mm per year, with a mean T1–S1 height of 10.1 mm per year. Conclusions: MCGR treatment allowed for an average correction of the curvature by 50% during the period of lengthening, while controlling any deformity and growth of the spine, with a significant increase in the T1–T12 and T1–S1 values during the observation period. MCGR treatment in EOS carries a risk of complications. While congenital and syndromic EOS often have short and less flexible curves in those groups of patients, single rods can be as effective and safe. Definitive fusion results in the mean final coronal correction between the start of MCGR treatment and after undergoing PSF of approximately 70%. The mean T1–T12 spinal height increased by 75 mm, while the T1–S1 spinal height gained a mean of 97 mm. Full article
(This article belongs to the Special Issue Spinal Disorders: Current Treatment and Future Opportunities: Part II)
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20 pages, 2424 KB  
Article
Comparative Analysis of Early and Long-Term Outcomes of Patients with Degenerative Lumbar Spine Disease Using the DIAM Stabilizer and Standard Rehabilitation Program: A Preliminary Prospective Randomized Controlled Trial with 1-Year Follow-Up
by Adam Druszcz, Maciej Miś, Małgorzata Paprocka-Borowicz, Joanna Rosińczuk and Bogdan Czapiga
Healthcare 2023, 11(22), 2956; https://doi.org/10.3390/healthcare11222956 - 13 Nov 2023
Cited by 1 | Viewed by 2491
Abstract
Low back pain (LBP) is a leading cause of disability and work absenteeism. The cause of LBP may be degeneration of the intervertebral disc. LBP is characterized by considerable variability and tends to develop into chronic pain. Treatment of LBP includes conservative and [...] Read more.
Low back pain (LBP) is a leading cause of disability and work absenteeism. The cause of LBP may be degeneration of the intervertebral disc. LBP is characterized by considerable variability and tends to develop into chronic pain. Treatment of LBP includes conservative and rehabilitative treatments, surgery, and so-called minimally invasive treatment. One of the most commonly performed procedures is interspinous stabilization using a dynamic interspinous DIAM (device for intervertebral assisted motion) stabilizer. There is still no clear, strong evidence for the effectiveness and superiority of surgical treatment over conservative treatment. This study aimed to compare the early and long-term outcomes of patients with LBP using the DIAM interspinous stabilizer in relation to patients treated conservatively. A group of 86 patients was prospectively randomized into two comparison groups: A (n = 43), treated with the DIAM dynamic stabilizer for degenerative lumbar spine disease (mean age = 43.4 years ± SD = 10.8 years), and B (n = 43), treated conservatively. Pain severity was assessed using the visual analog scale (VAS), whereas disability was assessed using the Oswestry disability index (ODI). The difference in preoperative and postoperative ODI scores ≥ 15 points was used as a criterion for treatment effectiveness, and the difference in VAS scores ≥ 1 point was used as a criterion for pain reduction. In patients under general anesthesia, the procedure only included implantation of the DIAM system. Patients in the control group underwent conservative treatment, which included rehabilitation, a bed regimen, analgesic drug treatment and periarticular spinal injections of anti-inflammatory drugs. It was found that all patients (n = 43) continued to experience LBP after DIAM implantation (mean VAS score of 4.2). Of the 36 patients who experienced LBP with sciatica before the procedure, 80.5% (n = 29) experienced a reduction in pain. As for the level of fitness, the average ODI score was 19.3 ± 10.3 points. As for the difference in ODI scores in the pre-treatment results vs. after treatment, the average score was 9.1 ± 10.6. None of the patients required reoperation at 12 months after surgery. There were no statistically significant differences between the two groups in either early (p = 0.45) or long-term outcomes (p = 0.37). In conclusion, neurosurgical treatment with the DIAM interspinous stabilizer was as effective as conservative treatment and rehabilitation during the one-year follow-up period. Full article
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14 pages, 3065 KB  
Article
Surgical Treatment of Adolescent Idiopathic Scoliosis with the ApiFix Minimal Invasive Dynamic Correction System—A Preliminary Report of a 24-Month Follow-Up
by Susanne Froehlich, Wolfram Mittelmeier, Biren Desai, Subash Jung Pandey, Herbert Raddatz, Bjoern Lembcke, Annett Klinder and Katrin Osmanski-Zenk
Life 2023, 13(10), 2032; https://doi.org/10.3390/life13102032 - 9 Oct 2023
Cited by 4 | Viewed by 4211
Abstract
Adolescent idiopathic scoliosis (AIS) is a three-dimensional growth disorder. Corrective surgical procedures are the recommended treatment option for a thoracic angle exceeding 50° and a lumbar major curve of 40°. Over the past few years, dynamic growth modulation implants have been developed as [...] Read more.
Adolescent idiopathic scoliosis (AIS) is a three-dimensional growth disorder. Corrective surgical procedures are the recommended treatment option for a thoracic angle exceeding 50° and a lumbar major curve of 40°. Over the past few years, dynamic growth modulation implants have been developed as alternatives to permanent fusion. The ApiFix system was designed as a 2D “posterior dynamic device” for curve correction. After implantation in a minimally invasive procedure, it uses polyaxial joints and a self-adjusting rod to preserve the degree of motion and to accommodate the patient’s growth. It provides an effective method of controlling deformity and fills the gap between the conservative treatment of major curves that are >35° and the fusion procedure. The objective of the two-center cohort study was the analysis of the correction results of patients, who underwent surgical intervention with the ApiFix system. The inclusion criteria were AIS, Lenke type 1 or type 5, a major curve on bending films of ≤30°, and an angle of the major curve of between 35° and 60°. Postoperative radiograph data were obtained longitudinally for up to 24 months of follow-up and compared to preoperative (preop) values. For comparisons of the different time points, non-parametric tests (Wilcoxon) or paired t-tests for normally distributed values were used to analyze repeated measures. Overall, 36 patients (25 female and 11 male) were treated with the ApiFix system from April 2018 to October 2020. Lenke type 1 was identified in 21 (58%) cases and Lenke type 5 was identified in 15 (42%) cases. The average angle of the thoracic major curve for Lenke 1 was 43°. The preoperative lumbar major curve (Lenke 5) was determined to be 43°. Over a follow-up of 24 months, a correction of the major curve to an average of 20° was observed for Lenke 1 and that to an average of 15° was observed for Lenke 5. Lenke type 1 and type 5 showed significant changes in the major curve over the individual test intervals in the paired comparisons compared to the starting angle (Lenke 1: preop—24 months, 0.002; Lenke 5: preop—24 months, 0.043). Overall, 11 events were recorded in the follow-up period, that required revision surgery. We distinguished between repeated interventions required after reaching the maximum distraction length of the implant due to the continued growth of the patient (n = 4) and complications, such as infections or problems associated with the anchorage of the implant (n = 7). The results from the present cohort revealed a statistically significant improvement in the postoperatively measured angles of the major and minor curves in the follow-up after 24 months. Consequently, the results were comparable to those of the already established vertebral body tethering method. Alignment in AIS via dynamic correction systems in combination with a possible growth modulation has been a treatment alternative to surgical fusing procedures for more than a decade. However, the long-term corrective effect has to be validated in further studies. Full article
(This article belongs to the Special Issue Orthopaedics and Traumatology: Surgery and Research)
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14 pages, 2433 KB  
Article
Biomechanical Effect of Hybrid Dynamic Stabilization Implant on the Segmental Motion and Intradiscal Pressure in Human Lumbar Spine
by Chih-Kun Hsiao, Yi-Jung Tsai, Cheng-Yo Yen, Yi-Chen Li, Hao-Yuan Hsiao and Yuan-Kun Tu
Bioengineering 2023, 10(1), 31; https://doi.org/10.3390/bioengineering10010031 - 26 Dec 2022
Cited by 7 | Viewed by 5030
Abstract
The hybrid dynamic stabilization system, Dynesys-Transition-Optima, represents a novel pedicle-based construct for the treatment of lumbar degenerative disease. The theoretical advantage of this system is to stabilize the treated segment and preserve the range of motion within the adjacent segment while potentially decreasing [...] Read more.
The hybrid dynamic stabilization system, Dynesys-Transition-Optima, represents a novel pedicle-based construct for the treatment of lumbar degenerative disease. The theoretical advantage of this system is to stabilize the treated segment and preserve the range of motion within the adjacent segment while potentially decreasing the risk of adjacent segment disease following lumbar arthrodesis. Satisfactory short-term outcomes were previously demonstrated in the Dynesys-Transition-Optima system. However, long-term follow-up reported accelerated degeneration of adjacent segments and segmental instability above the fusion level. This study investigated the biomechanical effects of the Dynesys-Transition-Optima system on segment motion and intradiscal pressure at adjacent and implanted levels. Segmental range of motion and intradiscal pressure were evaluated under the conditions of the intact spine, with a static fixator at L4–5, and implanted with DTO at L3–4 (Dynesys fixator) and L4–5 (static fixator) by applying the loading conditions of flexion/extension (±7.5 Nm) and lateral bending (±7.5 Nm), with/without a follower preload of 500 N. Our results showed that the hybrid Dynesys-Transition-Optima system can significantly reduce the ROM at the fusion level (L4–L5), whereas the range of motion at the adjacent level (L3–4) significantly increased. The increase in physiological loading could be an important factor in the increment of IDP at the intervertebral discs at the lumbar spine. The Dynesys-Transition-Optima system can preserve the mobility of the stabilized segments with a lesser range of motion on the transition segment; it may help to prevent the occurrence of adjacent segment degeneration. However, the current study cannot cover all the issues of adjacent segmental diseases. Future investigations of large-scale and long-term follow-ups are needed. Full article
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11 pages, 1645 KB  
Article
Comparison of the Optimal Design of Spinal Hybrid Elastic Rod for Dynamic Stabilization: A Finite Element Analysis
by Jui-Yang Hsieh, Chen-Sheng Chen, Shao-Ming Chuang, Jyh-Horng Wang, Po-Quang Chen and Yi-You Huang
Appl. Sci. 2022, 12(22), 11759; https://doi.org/10.3390/app122211759 - 19 Nov 2022
Cited by 2 | Viewed by 2285
Abstract
The spinal hybrid elastic (SHE) rod is a semi-rigid pedicle screw-based rod for spinal dynamic stabilization. This study investigated the biomechanical effects of different ratios of SHE rod using finite element analysis (FEA). A three-dimensional nonlinear FEA of an intact lumbar spine model [...] Read more.
The spinal hybrid elastic (SHE) rod is a semi-rigid pedicle screw-based rod for spinal dynamic stabilization. This study investigated the biomechanical effects of different ratios of SHE rod using finite element analysis (FEA). A three-dimensional nonlinear FEA of an intact lumbar spine model (INT) was constructed. The SHE rod was composed of an inner nitinol stick (NS) and an outer polycarbonate urethane shell (PS). Four groups implanted at L3–L4 had the same outer diameter (5.5 mm) but different NS diameter/PS thickness ratios: Nt45, Nt35, Nt25, and Nt15. The resultant intervertebral range of motion (ROM), disc stress, facet joint contact force, screw stress, NS stress, and PCU stress were analyzed. The results indicated that ROM, disc stress, and facet force decreased moderately in the implanted L3–L4 levels and increased slightly in the adjacent L2–L3 levels. The NS stress and NS diameter trended towards inverse proportionality. Changing the ratio did not markedly influence screw or PS stress. The SHE rod system with elastic NS and insulated PS has a 5.5 mm diameter for universal pedicle screws. The SHE rod system provides sufficient spinal support and increases gentle adjacent segment stress. Considering the durability, the optimal NS diameter/PS thickness ratio of the SHE rod system is 3.5/2.0 mm. Full article
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14 pages, 5627 KB  
Article
Continuous Rod Load Monitoring to Assess Spinal Fusion Status–Pilot In Vivo Data in Sheep
by Markus Windolf, Maximilian Heumann, Viktor Varjas, Caroline Constant, Manuela Ernst, Robert Geoff Richards, Hans-Joachim Wilke and Lorin Michael Benneker
Medicina 2022, 58(7), 899; https://doi.org/10.3390/medicina58070899 - 6 Jul 2022
Cited by 17 | Viewed by 3917
Abstract
Background and Objectives: Spinal fusion is an effective and widely accepted intervention. However, complications such as non-unions and hardware failures are frequently observed. Radiologic imaging and physical examination are still the gold standards in the assessment of spinal fusion, despite multiple limitations [...] Read more.
Background and Objectives: Spinal fusion is an effective and widely accepted intervention. However, complications such as non-unions and hardware failures are frequently observed. Radiologic imaging and physical examination are still the gold standards in the assessment of spinal fusion, despite multiple limitations including radiation exposure and subjective image interpretation. Furthermore, current diagnostic methods only allow fusion assessment at certain time points and require the patient’s presence at the hospital or medical practice. A recently introduced implantable sensor system for continuous and wireless implant load monitoring in trauma applications carries the potential to overcome these drawbacks, but transferability of the principle to the spine has not been demonstrated yet. Materials and Methods: The existing trauma sensor was modified for attachment to a standard pedicle-screw-rod system. Two lumbar segments (L2 to L4) of one Swiss white alpine sheep were asymmetrically instrumented. After facetectomy, three sensors were attached to the rods between each screw pair and activated for measurement. The sheep was euthanized 16 weeks postoperatively. After radiological assessment the spine was explanted and loaded in flexion-extension to determine the range of motion of the spinal segments. Sensor data were compared with mechanical test results and radiologic findings. Results: The sensors measured physiological rod loading autonomously over the observation period and delivered the data daily to bonded smartphones. At euthanasia the relative rod load dropped to 67% of the respective maximum value for the L23 segment and to 30% for the L34 segment. In agreement, the total range of motion of both operated segments was lower compared to an intact reference segment (L23: 0.57°; L34: 0.49°; intact L45: 4.17°). Radiologic assessment revealed fusion mass in the facet joint gaps and bilateral bridging bone around the joints at both operated segments. Conclusions: Observations of this single-case study confirm the basic ability of continuous rod load measurement to resolve the spinal fusion process as indicated by a declining rod load with progressing bone fusion. A strong clinical potential of such technology is eminent, but further data must be collected for final proof of principle. Full article
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23 pages, 904 KB  
Review
Metallic Implants Used in Lumbar Interbody Fusion
by Jakub Litak, Michał Szymoniuk, Wojciech Czyżewski, Zofia Hoffman, Joanna Litak, Leon Sakwa and Piotr Kamieniak
Materials 2022, 15(10), 3650; https://doi.org/10.3390/ma15103650 - 20 May 2022
Cited by 31 | Viewed by 8772
Abstract
Over the last decade, pedicle fixation systems have evolved and modifications in spinal fusion techniques have been developed to increase fusion rates and improve clinical outcomes after lumbar interbody fusion (LIF). Regarding materials used for screw and rod manufacturing, metals, especially titanium alloys, [...] Read more.
Over the last decade, pedicle fixation systems have evolved and modifications in spinal fusion techniques have been developed to increase fusion rates and improve clinical outcomes after lumbar interbody fusion (LIF). Regarding materials used for screw and rod manufacturing, metals, especially titanium alloys, are the most popular resources. In the case of pedicle screws, that biomaterial can be also doped with hydroxyapatite, CaP, ECM, or tantalum. Other materials used for rod fabrication include cobalt–chromium alloys and nitinol (nickel–titanium alloy). In terms of mechanical properties, the ideal implant used in LIF should have high tensile and fatigue strength, Young’s modulus similar to that of the bone, and should be 100% resistant to corrosion to avoid mechanical failures. On the other hand, a comprehensive understanding of cellular and molecular pathways is essential to identify preferable characteristics of implanted biomaterial to obtain fusion and avoid implant loosening. Implanted material elicits a biological response driven by immune cells at the site of insertion. These reactions are subdivided into innate (primary cellular response with no previous exposure) and adaptive (a specific type of reaction induced after earlier exposure to the antigen) and are responsible for wound healing, fusion, and also adverse reactions, i.e., hypersensitivity. The main purposes of this literature review are to summarize the physical and mechanical properties of metal alloys used for spinal instrumentation in LIF which include fatigue strength, Young’s modulus, and corrosion resistance. Moreover, we also focused on describing biological response after their implantation into the human body. Our review paper is mainly focused on titanium, cobalt–chromium, nickel–titanium (nitinol), and stainless steel alloys. Full article
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14 pages, 332 KB  
Review
Hydroxyapatite Use in Spine Surgery—Molecular and Clinical Aspect
by Jakub Litak, Wojciech Czyzewski, Michał Szymoniuk, Bartlomiej Pastuszak, Joanna Litak, Grzegorz Litak, Cezary Grochowski, Mansur Rahnama-Hezavah and Piotr Kamieniak
Materials 2022, 15(8), 2906; https://doi.org/10.3390/ma15082906 - 15 Apr 2022
Cited by 31 | Viewed by 5139
Abstract
Hydroxyapatite possesses desirable properties as a scaffold in tissue engineering: it is biocompatible at a site of implantation, and it is degradable to non-toxic products. Moreover, its porosity enables infiltration of cells, nutrients and waste products. The outcome of hydroxyapatite implantation highly depends [...] Read more.
Hydroxyapatite possesses desirable properties as a scaffold in tissue engineering: it is biocompatible at a site of implantation, and it is degradable to non-toxic products. Moreover, its porosity enables infiltration of cells, nutrients and waste products. The outcome of hydroxyapatite implantation highly depends on the extent of the host immune response. Authors emphasise major roles of the chemical, morphological and physical properties of the surface of biomaterial used. A number of techniques have been applied to transform the theoretical osteoconductive features of HAp into spinal fusion systems—from integration of HAp with autograft to synthetic intervertebral implants. The most popular uses of HAp in spine surgery include implants (ACDF), bone grafts in posterolateral lumbar fusion and transpedicular screws coating. In the past, autologous bone graft has been used as an intervertebral cage in ACDF. Due to the morbidity related to autograft harvesting from the iliac bone, a synthetic cage with osteoconductive material such as hydroxyapatite seems to be a good alternative. Regarding posterolateral lumbar fusion, it requires the graft to induce new bone growth and reinforce fusion between the vertebrae. Hydroxyapatite formulations have shown good results in that field. Moreover, the HAp coating has proven to be an efficient method of increasing screw fixation strength. It can decrease the risk of complications such as screw loosening after pedicle screw fixation in osteoporotic patients. The purpose of this literature review is to describe in vivo reaction to HAp implants and to summarise its current application in spine surgery. Full article
(This article belongs to the Special Issue Multiple Applications of Hydroxyapatite-Based Materials)
18 pages, 5605 KB  
Article
Novel Mg-0.5Ca-xMn Biodegradable Alloys Intended for Orthopedic Application: An In Vitro and In Vivo Study
by Corneliu Munteanu, Daniela Maria Vlad, Eusebiu-Viorel Sindilar, Bogdan Istrate, Maria Butnaru, Sorin Aurelian Pasca, Roxana Oana Nastasa, Iuliana Mihai and Stefan-Lucian Burlea
Materials 2021, 14(23), 7262; https://doi.org/10.3390/ma14237262 - 27 Nov 2021
Cited by 7 | Viewed by 2568
Abstract
Mg-based biodegradable materials, used for medical applications, have been extensively studied in the past decades. The in vitro cytocompatibility study showed that the proliferation and viability (as assessed by quantitative MTT-assay—3-(4,5-dimethyltiazol-2-yl)-2,5-diphenyl tetrazolium bromide) were not negatively affected with time by the addition of [...] Read more.
Mg-based biodegradable materials, used for medical applications, have been extensively studied in the past decades. The in vitro cytocompatibility study showed that the proliferation and viability (as assessed by quantitative MTT-assay—3-(4,5-dimethyltiazol-2-yl)-2,5-diphenyl tetrazolium bromide) were not negatively affected with time by the addition of Mn as an alloying element. In this sense, it should be put forward that the studied alloys don’t have a cytotoxic effect according to the standard ISO 10993-5, i.e., the level of the cells’ viability (cultured with the studied experimental alloys) attained both after 1 day and 5 days was over 82% (i.e., 82, 43–89, 65%). Furthermore, the fibroblastic cells showed variable morphology (evidenced by fluorescence microscopy) related to the alloy sample’s proximity (i.e., related to the variation on the Ca, Mg, and Mn ionic concentration as a result of alloy degradation). It should be mentioned that the cells presented a polygonal morphology with large cytoplasmic processes in the vicinity of the alloy’s samples, and a bipolar morphology in the remote region of the wells. Moreover, the in vitro results seem to indicate that only 0.5% Mn is sufficient to improve the chemical stability, and thus the cytocompatibility; from this point of view, it could provide some flexibility in choosing the right alloy for a specific medical application, depending on the specific parameters of each alloy, such as its mechanical properties and corrosion resistance. In order to assess the in vivo compatibility of each concentration of alloy, the pieces were implanted in four rats, in two distinct body regions, i.e., the lumbar and thigh. The body’s reaction was followed over time, 60 days, both by general clinical examinations considering macroscopic changes, and by laboratory examinations, which revealed macroscopic and microscopic changes using X-rays, CT(Computed Tomography), histology exams and SEM (Scanning Electron Microscopy). In both anatomical regions, for each of the tested alloys, deformations were observed, i.e., a local reaction of different intensities, starting the day after surgery. The release of hydrogen gas that forms during Mg alloy degradation occurred immediately after implantation in all five of the groups examined, which did not affect the normal functionality of the tissues surrounding the implants. Imaging examinations (radiological and CT) revealed the presence of the alloy and the volume of hydrogen gas in the lumbar and femoral region in varying amounts. The biodegradable alloys in the Mg-Ca-Mn system have great potential to be used in orthopedic applications. Full article
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