INTRODUCTION: This study aimed to assess the impact of midline lumbar fusion with cortical bone trajectory screws (MIDLF/CBT) on the multifidus muscles, focusing on the evaluation of their postoperative atrophy. CLINICAL RATIONALE FOR THE STUDY: MIDLF/CBT is a relatively new technique increasingly used to treat spinal instability. Despite its reduced invasiveness compared to traditional posterior lumbar interbody fusion with traditional pedicle screws (PLIF/TP), concerns remain about potential damage to the multifidus muscles that are crucial for spinal stability. Understanding the extent of muscular atrophy post-MIDLF/CBT is vital for improving surgical outcomes, and potentially patient rehabilitation strategies. MATERIAL AND METHODS: This study retrospectively analysed preoperative and postoperative MRI scans of patients who underwent MIDLF/CBT for degenerative segmental spondylolisthesis. The bilateral width of the multifidus muscles at the operated segment and adjacent segments was measured using axial T2-weighted MRI scans. Statistical comparisons were made using a paired t test, with significance set at p < 0.05. RESULTS: The study included 16 patients with an average age of 57 ± 10 years, 10 of whom (62.5%) were women, and featured a mean follow-up period of 37 ± 25 months. Postoperative measurements showed a significant reduction in the width of the multifidus muscles at the operated segment (mean difference -3.3mm, p = 0.02) and the inferior adjacent segment (-7.4 mm, p < 0.01). A decrease in muscle width at the superior adjacent segment was also observed, although this was not statistically significant. CONCLUSIONS AND CLINICAL IMPLICATIONS: Our study concluded that MIDLF/CBT results in significant multifidus muscle atrophy at and below the operated segment, potentially impacting postoperative rehabilitation and recovery. These findings highlight the need for further research comparing MIDLF/CBT to other spinal stabilisation techniques. Additionally, incorporating functional electromyographic assessments of paraspinal muscles could provide deeper insights into the long-term consequences of spinal surgeries and helpdevelop new approaches and strategies to mitigate paravertebral muscles atrophy, thus enhancing patient outcomes.
- MeSH
- bederní obratle * chirurgie diagnostické zobrazování MeSH
- fúze páteře * metody MeSH
- hluboké zádové svaly * diagnostické zobrazování patologie MeSH
- kortikální kost chirurgie diagnostické zobrazování MeSH
- lidé středního věku MeSH
- lidé MeSH
- magnetická rezonanční tomografie MeSH
- pedikulární šrouby MeSH
- pooperační komplikace diagnostické zobrazování MeSH
- retrospektivní studie MeSH
- senioři MeSH
- spondylolistéza * chirurgie diagnostické zobrazování MeSH
- svalová atrofie * etiologie diagnostické zobrazování MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
CONTEXT: SB16 is a proposed biosimilar to reference denosumab (DEN; brand name: Prolia). OBJECTIVE: This phase 3 randomized, double-blind, multicenter study evaluated the biosimilarity of SB16 to DEN in women with postmenopausal osteoporosis (NCT04664959). DESIGN: The study included 457 postmenopausal osteoporosis patients who had a lumbar spine or total hip T-score between -2.5 and -4. Patients were randomized in a 1:1 ratio to receive either 60 mg of SB16 or DEN subcutaneously at month 0 and month 6. At month 12, patients were rerandomized to continue with the assigned treatment or switch from DEN to SB16 up to month 18. This report includes results up to month 12. METHODS: The primary endpoint was the percent change from baseline in lumbar spine bone mineral density (BMD) at month 12. Secondary endpoints including the percent change from baseline in BMD of the lumbar spine (except for month 12), total hip, and femoral neck; pharmacokinetic, pharmacodynamic (serum C-telopeptide of type I collagen, and procollagen type I N-terminal propeptide), safety, and immunogenicity profiles were measured up to month 12. RESULTS: The least-squares mean differences in percent change from baseline in lumbar spine BMD at month 12 were 0.33% (90% CI, -0.25 to 0.91) in the full analysis set and 0.39% (95% CI, -0.36 to 1.13) in the per-protocol set; both within the predefined equivalence margin. The secondary endpoints were comparable between the 2 treatment groups. CONCLUSION: The reported efficacy, pharmacokinetic, pharmacodynamic, safety, and immunogenicity data support the biosimilarity of SB16 to DEN.
- MeSH
- bederní obratle účinky léků diagnostické zobrazování MeSH
- biosimilární léčivé přípravky * terapeutické užití farmakokinetika aplikace a dávkování škodlivé účinky MeSH
- denosumab * terapeutické užití farmakokinetika škodlivé účinky aplikace a dávkování MeSH
- dvojitá slepá metoda MeSH
- inhibitory kostní resorpce * terapeutické užití farmakokinetika aplikace a dávkování škodlivé účinky MeSH
- kostní denzita účinky léků MeSH
- lidé středního věku MeSH
- lidé MeSH
- postmenopauzální osteoporóza * farmakoterapie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
PURPOSE: The aim of this study was to compare the accuracy of two spine models: the broken curve model and a new four tangent circles model. The modification concerns the adaptation of data acquisition to kinematic methods used in, e.g., gait and running analysis. METHOD: Plastic, movable spine model of human with flexible intervertebral disks (manufactured by Erler Zimmer GE3014) was used as the study material. Markers with a diameter of 5 mm were glued to each spinous process (from C7 to L5). The recording was performed with a 6-camera Vicon system. Two spine models were created: a broken curve model used, among others, in the Diers scanner, and an own model of 4 circles, similar to the model of circles used in X-ray and CT analysis. RESULTS: The errors in the position of the spinous processes were significantly smaller in the 4-circle model than in the broken curve model. They ranged from 0.01 to 6.5 mm in the lumbar section, from 0.004 to 3.1 mm in the thoracic section. The practical possibilities of using the four-circle model during the cinematographic analysis of gait and run should be checked. CONCLUSION: The four-circle model is more accurate than the broken curve model and can be used in the cinematographic analysis of the human spine movement.
PURPOSE: This study evaluated the efficacy, safety, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of SB16 versus reference denosumab (DEN) up to 18 months in postmenopausal osteoporosis (PMO) patients, and assessed outcomes after switching from DEN to SB16 compared to those who continued with DEN or SB16. METHODS: 457 PMO patients were initially randomized, with 407 re-randomized at Month 12 to either continue DEN (DEN+DEN), switch to SB16 (DEN+SB16), or continue SB16 (SB16 + SB16) through Month 18. Efficacy was assessed by the percent change from baseline in bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck. Safety, PD, PK, and immunogenicity were evaluated throughout the study period. RESULTS: Mean percent changes from baseline in lumbar spine, total hip, and femoral neck BMD at Month 18 were comparable across treatment groups, indicating comparable efficacy between SB16 and DEN. The mean percent change in lumbar spine BMD was 6.8 % (SB16 + SB16), 6.2 % (DEN+SB16), and 6.8 % (DEN+DEN). Total hip BMD increased by 4.4 %, 3.5 %, and 4.0 %, and femoral neck BMD by 3.4 %, 3.1 %, and 2.7 % for SB16 + SB16, DEN+SB16, and DEN+DEN, respectively. Safety profiles were similar among groups, with no new safety concerns identified after switching. Only one patient in the DEN+SB16 group developed non-neutralizing anti-drug antibodies by Month 18, indicating a low immunogenicity risk for SB16. CONCLUSION: Switching from DEN to SB16 demonstrated comparable efficacy, safety, PD, PK, and immunogenicity in PMO patients relative to those who continued DEN. SB16 was well tolerated over 18 months, demonstrating comparable outcomes to DEN.
- MeSH
- bederní obratle účinky léků MeSH
- denosumab * terapeutické užití MeSH
- inhibitory kostní resorpce * terapeutické užití MeSH
- kostní denzita * účinky léků MeSH
- lidé středního věku MeSH
- lidé MeSH
- postmenopauzální osteoporóza * farmakoterapie MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND: A comparison of fusion rates and clinical outcomes of instrumented transforaminal interbody fusion (TLIF) between polyetheretherketone (PEEK) and titanium-coated PEEK (Ti-PEEK) cages is not well documented. METHODS: A single-centre, prospective, randomised study included patients who underwent one-level TLIF between L3-S1 segments. Patients were randomised into one of two groups: TLIF surgery with the PEEK cage and TLIF surgery with the Ti-PEEK cage. Clinical results were measured. All patients were assessed by repeated X-rays and 3D CT scans. Cage integration was assessed using a modified Bridwell classification. The impact of obesity and smoking on fusion quality was also analysed. Patients in both groups were followed up for 2 years. RESULTS: Altogether 87 patients were included in the study: of these 87 patients, 81 (93.1%) completed the 2-year follow-up. A significant improvement in clinical outcome was found in the two measurements scales in both groups (RM: p = 0.257, VAS: p = 0.229). There was an increase in CobbS and CobbL angle in both groups (p = 0.172 for CobbS and p = 0.403for CobbL). Bony fusion was achieved in 37 of 40 (92.5%) patients in the TiPEEK group and 35 of 41 (85.4%) in the PEEK group (p = 0.157). Cage subsided in 2 of 40 patients (5%) in the TiPEEK group and 11 of 41 (26.8%) in the PEEK group (p = 0.007). Body mass index > 30 and smoking were not predictive factors of bony fusion achievement. CONCLUSION: There is no significant advantage of TiPEEK cages over PEEK cages in clinical outcome and fusion rate 2 years after surgery.
- MeSH
- bederní obratle chirurgie MeSH
- benzofenony * MeSH
- fúze páteře * metody MeSH
- ketony MeSH
- lidé MeSH
- polyethylenglykoly MeSH
- polymery * MeSH
- prospektivní studie MeSH
- titan * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
This study aimed to characterize the mechanical properties of native human ligamentum flavum (LF) and correlate them with histopathological changes. Mechanical property gradients across the cranial, medial, and caudal regions of LF were mapped and compared with histological sections. We also compared lumbar spinal stenosis (LSS) samples with disc herniation (DH) samples as reference material to identify differences in mechanical properties and histopathological features. Our results revealed significant heterogeneity in LF mechanical properties, with local variations correlating with specific histopathological changes such as chondroid metaplasia and loss of elastic fibers. These findings underscore the importance of considering LF heterogeneity in mechanical characterization and provide insights into its behavior under pathological conditions.
- MeSH
- bederní obratle * patologie MeSH
- biomechanika MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- ligamentum flavum * patologie MeSH
- mechanický stres MeSH
- senioři MeSH
- spinální stenóza * patologie MeSH
- výhřez meziobratlové ploténky * patologie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
V souvislosti se zařazením nové položky Seznamu nemocí z povolání (příloha nařízení vlády č. 290/1995 Sb. v platném znění) ke dni 1. 1. 2023 – chronického onemocnění bederní páteře z přetěžování pohybového aparátu [5] vznikla potřeba relevantního hodnocení profesionální expozice faktorům, které se na jejím vzniku podílejí. Vzhledem k tomu, že expoziční kritéria, vycházející z limitu NIOSH US, nezahrnují komplexní rozsah možných působících sil a současně nezohledňují dobu výkonu práce, předkládají autoři z důvodu nezbytné standardizace metodických postupů autorizovaných laboratoří matematický model zpracování výsledků hodnocení této zátěže, které navazují na výstupy ze software Back Solver.
In connection with the inclusion of a new item in the List of Occupational Diseases (Annex to Government Regulation No. 290/1995 Coll., as amended) as of 1 January 2023 – chronic lumbar spine disease from overloading the musculoskeletal system [5], the need for a relevant assessment of occupational exposure to the factors involved in its occurrence has arisen. With regard to the fact that the exposure criteria, based on the NIOSH US limit, do not include a comprehensive range of possible acting forces and at the same time do not take into account the time of work, the authors present a mathematical model of processing the results of the evaluation of this load, which follow the outputs from the Back Solver software, due to the necessary standardization of methodological procedures of authorized laboratories.
The purpose of the study was to determine whether running is associated with greater bone mineral density (BMD) by comparing the BMD of regularly active male runners (AR) with inactive nonrunner male controls (INC). This cross-sectional study recruited 327 male AR and 212 male INC (aged 18-65) via a stratified recruitment strategy. BMD of the whole body (WB) and partial segments (spine, lumbar spine (LS), leg, hip, femoral neck (FN), and arm for each side) were measured by dual-energy x-ray absorptiometry (DXA) and lower leg dominance (dominant-D/nondominant-ND) was established by functional testing. An ANCOVA was used to compare AR and INC. The AR had greater BMD for all segments of the lower limb (p<0.05), but similar BMD for all segments of the upper limb (p>0.05) compared with INC. Based on the pairwise comparison of age groups, AR had greater BMD of the ND leg in every age group compared with INC (p<0.05). AR had grater BMD of the D leg in every age group except for (26-35 and 56-65) compare with INC (p<0.05). In the youngest age group (18-25), AR had greater BMD in every measured part of lower extremities (legs, hips, femoral necks) compared with INC (p<0.05). In the 46-55 age group AR had greater BMD than INC (p < 0.05) only in the WB, D Leg, D neck, and ND leg. In the 56-65 age group AR had greater BMD than INC (p<0.05) only in the ND leg. Overall, AR had greater BMD compared with INC in all examined sites except for the upper limbs, supporting the notion that running may positively affect bone parameters. However, the benefits differ in the skeletal sites specifically, as the legs had the highest BMD difference between AR and INC. Moreover, the increase in BMD from running decreased with age.
- MeSH
- absorpční fotometrie * MeSH
- bederní obratle fyziologie diagnostické zobrazování MeSH
- běh * fyziologie MeSH
- dospělí MeSH
- kostní denzita * fyziologie MeSH
- krček femuru diagnostické zobrazování fyziologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- průřezové studie MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
BACKGROUND: Together with an increased interest in minimally invasive lateral transpsoas approach to the lumbar spine goes a demand for detailed anatomical descriptions of the lumbar plexus. Although definitions of safe zones and essential descriptions of topographical anatomy have been presented in several studies, the existing literature expects standard appearance of the neural structures. Therefore, the aim of this study was to investigate the variability of the extrapsoas portion of the lumbar plexus in regard to the lateral transpsoas approach. METHODS: A total of 260 lumbar regions from embalmed cadavers were utilized in this study. The specimens were dissected as per protocol and all nerves from the lumbar plexus were morphologically evaluated. RESULTS: The most common variation of the iliohypogastric and ilioinguinal nerves was fusion of these two nerves (9.6%). Nearly in the half of the cases (48.1%) the genitofemoral nerve left the psoas major muscle already divided into the femoral and genital branches. The lateral femoral cutaneous nerve was the least variable one as it resembled its normal morphology in 95.0% of cases. Regarding the variant origins of the femoral nerve, there was a low formation outside the psoas major muscle in 3.8% of cases. The obturator nerve was not variable at its emergence point but frequently branched (40.4%) before entering the obturator canal. In addition to the proper femoral and obturator nerves, accessory nerves were present in 12.3% and 9.2% of cases, respectively. CONCLUSION: Nerves of the lumbar plexus frequently show atypical anatomy outside the psoas major muscle. The presented study provides a compendious information source of the possibly encountered neural variations during retroperitoneal access to different segments of the lumbar spine.
- MeSH
- bederní obratle * chirurgie anatomie a histologie MeSH
- bederní svaly * anatomie a histologie chirurgie MeSH
- lidé MeSH
- miniinvazivní chirurgické výkony metody MeSH
- mrtvola * MeSH
- nervus femoralis anatomie a histologie chirurgie MeSH
- nervus obturatorius anatomie a histologie chirurgie MeSH
- plexus lumbosacralis * anatomie a histologie chirurgie MeSH
- senioři MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH