Dataset Information

Evaluation of an Injectable Biphasic Calcium Sulfate/Hydroxyapatite Cement for the Augmentation of Fenestrated Pedicle Screws in Osteoporotic Vertebrae: A Biomechanical Cadaver Study.

ABSTRACT: Cement augmentation of pedicle screws is one of the most promising approaches to enhance the anchoring of screws in the osteoporotic spine. To date, there is no ideal cement for pedicle screw augmentation. The purpose of this study was to investigate whether an injectable, bioactive, and degradable calcium sulfate/hydroxyapatite (CaS/HA) cement could increase the maximum pull-out force of pedicle screws in osteoporotic vertebrae. Herein, 17 osteoporotic thoracic and lumbar vertebrae were obtained from a single fresh-frozen human cadaver and instrumented with fenestrated pedicle screws. The right screw in each vertebra was augmented with CaS/HA cement and the un-augmented left side served as a paired control. The cement distribution, interdigitation ability, and cement leakage were evaluated using radiographs. Furthermore, pull-out testing was used to evaluate the immediate mechanical effect of CaS/HA augmentation on the pedicle screws. The CaS/HA cement presented good distribution and interdigitation ability without leakage into the spinal canal. Augmentation significantly enhanced the maximum pull-out force of the pedicle screw in which the augmented side was 39.0% higher than the pedicle-screw-alone side. Therefore, the novel biodegradable biphasic CaS/HA cement could be a promising material for pedicle screw augmentation in the osteoporotic spine.

SUBMITTER: Tian X

PROVIDER: S-EPMC9786089 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Evaluation of an Injectable Biphasic Calcium Sulfate/Hydroxyapatite Cement for the Augmentation of Fenestrated Pedicle Screws in Osteoporotic Vertebrae: A Biomechanical Cadaver Study.

Tian Xinggui X Raina Deepak B DB Vater Corina C Kilian David D Ahlfeld Tilman T Platzek Ivan I Nimtschke Ute U Tägil Magnus M Lidgren Lars L Thomas Alexander A Platz Uwe U Schaser Klaus-Dieter KD Disch Alexander C AC Zwingenberger Stefan S

Journal of functional biomaterials 20221201 4

Cement augmentation of pedicle screws is one of the most promising approaches to enhance the anchoring of screws in the osteoporotic spine. To date, there is no ideal cement for pedicle screw augmentation. The purpose of this study was to investigate whether an injectable, bioactive, and degradable calcium sulfate/hydroxyapatite (CaS/HA) cement could increase the maximum pull-out force of pedicle screws in osteoporotic vertebrae. Herein, 17 osteoporotic thoracic and lumbar vertebrae were obtaine ...[more]

PMID: 36547529

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Project description:BackgroundIn atlantoaxial instabilities, posterior C1/C2 fusion using lateral mass screws (LMS) or pedicle screws (PS) in a mono- or bicortical position in the atlas is a typical treatment. The bone microstructure and positioning of the screw trajectories appear to be of significant relevance for stability.PurposeThe aim of this study was a comparative analysis of the mechanical durability of screw fixation concerning microstructural characteristics of the trajectories of LMS and PS in mono- and bicortical position.MethodsHuman C1 from geriatric body donors (n = 28; 50% female, age 80.8 ± 13.9 years) were collected and characterized based on their bone microstructure. Additionally, the mechanical stability of LMS and PS fixation in mono- and bicortical positioning was tested by mechanical loading. High-resolution quantitative computed tomography was used to analyze the bone microstructure of cylinders corresponding to the trajectories of PS and LMS in mono- and bicortical locations in each C1. After instrumentation with both screw types and types of fixation, the mechanical stability was tested by increased cyclic loading in cranio-caudal direction.ResultsTrajectories of PS presented with more bone volume and a higher contact length to cortical bone. Simultaneously, a higher number of cycles and a higher maximum force was needed to loosen PS compared to LMS, while the loose by torque at the experiment end was still greater in PS. Differences between mono- and bicortical positioning of PS and LMS have only been observed in the initial stiffness of screws. When comparing microstructural and mechanical properties, the cortical contact length and bone volume in screw trajectories were strongest associated with a high loose and cycle count.ConclusionsThis study suggests that mono- and bicortical positioning of PS is similarly efficient in creating a stable basis for screw fixation in the atlas. While PS are superior to LMS, the contact with cortical bone is of major relevance for a stable foundation.

Project description:BackgroundThe incidence of cancer patients with bone metastasis is increasing annually. With the advancement of medical treatment for malignant tumors, the survival time of patients with spinal metastases is gradually being prolonged, and adjacent segment vertebral metastases often occur after conventional pedicle screw (CPS) surgery, leading to spinal instability, pain and nerve function injury again, with repeated symptoms. Combined pedicle screw fixation can maintain or reconstruct the spinal stability. This study aimed to investigate the efficacy and safety of cement-augmented fenestrated pedicle screws in the posterior approach for spinal metastases by comparing with CPS.MethodsFrom January 2017 to August 2019, 52 patients with spinal metastases who underwent separation surgery and internal fixation via posterior approach were retrospectively enrolled. Cases were divided into the cement-augmented pedicle screw (CAPS) group (28 cases) and the CPS group (24 cases). The baseline data [age, gender, surgical sites, surgical segment, Tomita classification, Tomita score, Tokuhashi score, spinal instability neoplastic score (SINS)], surgical information, and local progression-free survival (PFS) time were compared between the two groups. Every patient was followed-up every 3 months with imaging examination. The visual analog scale (VAS) score and Frankel grade of the two groups were recorded before and 3 months after the operation were used to evaluate the efficacy. The operation time, the amount of intraoperative blood loss, the amount of bone cement injected in the pedicle screw group, and the complications of the surgery were recorded to evaluate the safety of CAPS.ResultsThe baseline characteristics were comparable between the two group. Compared with the CPS group, the CAPS group showed significantly longer operation time (163±20 vs. 138±18 min, P<0.001) and lower VAS scores (2.93±1.33 vs. 4.17±1.34, P=0.002). Adjacent segment vertebral metastasis occurred in 10 cases (2 in the CAPS group and 8 in the CPS group, P=0.017). Internal implant failure occurred in 8 cases (1 in the CAPS group and 7 in the CPS group, P=0.011). Compared with the CPS group, the CAPS group had a significantly longer local PFS time (P<0.05).ConclusionsCAPS could be a safe and effective choice in surgery for spinal metastases with the posterior approach.

Project description:Pedicles are often broken when screws are inserted into hard pedicles with small diameters or when the diameter of the screw itself is inadequate. However, there is a lack of biomechanical literature that addresses screw loosening as a result of broken pedicles or the resulting salvage of those screws. We performed a novel in vitro study to compare the pullout strength of screws between intact pedicles and two different types of broken pedicles; strategies to prevent screw loosening were also compared. Thirty L4 Sawbones were designed to represent intact pedicles, semi-pedicles, and nonpedicles and were prepared for screw insertion. Three sizes of polyaxial screws (diameter × length dimensions of 6.0 mm × 45 mm, 6.0 mm × 50 mm and 6.5 mm × 45 mm) were independently and randomly distributed into the intact-pedicle group (IP group, n = 30), the semi-pedicle group (SP group, n = 15), or the nonpedicle group (NP group, n = 15). The experiments were conducted across a minimum of five trials for each of the chosen screw sizes. We then analyzed the results of the imaging, pullout testing, and embedded bone volume. Any fractures or defects of the vertebrae caused by screw insertion were excluded from the study. The appropriate screw trajectory and insertional depth were confirmed using axial and sagittal X-ray imaging prior to screw pullout testing. A pullout strength of only 41% to 45% for the SP group and 29% to 39% for the NP group was retained following a broken pedicle. The use of longer or larger-diameter screws appears to be an effective salvaging procedure for the NP group (p < 0.05). The embedded bone volume percentage analysis indicated that, compared to the IP group, 68% to 76% of effective bone embedded into the screw threads in the SP group, and 58% to 65% in the NP group. There was no direct correlation between the pullout strength and the embedded bone volume; however, less effective embedded bone volume was associated with lower pullout strength. This study describes the evolution of the well-established screw pullout test being applied to the broken pedicle Sawbone testing model. The pedicle plays an important role in determining the pullout strength of a screw. However, a salvage procedure that utilizes a longer or larger-diameter screw might be a reliable clinical approach to address broken pedicles.

Project description:BackgroundCement-augmented pedicle screw instrumentation (CAPSI) has been proven to significantly increase the biomechanical stability in the osteoporotic lumbar spine. However, besides the merits, it is responsible for the inevitable cement leakage growing with more instrumented segments and volumes involved. This study aimed to compare the biomechanical performance of pedicle screws augmented on all segments with those augmented only on the cranial and caudal vertebrae selectively.MethodsThe finite element model of L3-S1 was modeled with the CT data of a healthy volunteer, the solid/fenestrated pedicle screws from micro-CT scans of physical screws, and bone cement from the CT scans of a postoperative patient with CAPSI. Three different augmented strategies for pedicle screws were taken into consideration: augmentation at each pedicle trajectory (Model A), selective augmentation at the cranial and caudal pedicle trajectories (Model B), and pedicle trajectories without augmentation (Model C). A total of six surgical models were constructed: Models A, B, and C were subdivided into double segmental fusion from L4 to S1 (Models A1, B1, and C1) and multi-segment fusion from L3 to S1 (Models A2, B2, and C2). The Range of motion (ROM), stress on the cage, and stress on the fixed segments were compared among the six models.ResultsThe ROM at the fusion segments decreased in all instrumentation models. The ROMs of Model B and Model A are similar in each direction, while that of Model C is significantly larger. The differences in the ROMs between Model A and Model B were noted to be less than 0.1°. Compared with Models A1 and A2, the peak Von Mise stress on the cage-endplate interface and pedicle screws were slightly higher in Models B1 and B2. In contrast, the stress of Models C1 and C2 increased significantly. The compressive stress was concentrated in the screw head, the cranial and caudal screws, and rods.ConclusionsThe selective augmentation of pedicle screws is capable of providing reliable stability in short-segment posterior fixation (2- or 3-level). It could be a potential optimal procedure to minimize the associated complications of CAPSI.

Project description:BackgroundPedicle screw insertion in osteoporotic patients is challenging. Achieving more screw-cortical bone purchase and invasiveness minimization, the cortical bone trajectory and the midline cortical techniques represent alternatives to traditional pedicle screws. This study compares the fatigue behavior and fixation strength of the cement-augmented traditional trajectory (TT), the cortical bone trajectory (CBT), and the midline cortical (MC).MethodsTen human cadaveric spine specimens (L1 - L5) were examined. The average age was 86.3 ± 7.2 years. CT scans were provided for preoperative planning. CBT and MC were implanted by using the patient-specific 3D-printed placement guide (MySpine®, Medacta International), TT were implanted freehand. All ten cadaveric specimens were randomized to group A (CBT vs. MC) or group B (MC vs. TT). Each screw was loaded for 10,000 cycles. The failure criterion was doubling of the initial screw displacement resulting from the compressive force (60 N) at the first cycle, the stop criterion was a doubling of the initial screw displacement. After dynamic testing, screws were pulled out axially at 5 mm/min to determine their remaining fixation strength.ResultsThe mean pull-out forces did not differ significantly. Concerning the fatigue performance, only one out of ten MC of group A failed prematurely due to loosening after 1500 cycles (L3). Five CBT already loosened during the first 500 cycles. The mean displacement was always lower in the MC. In group B, all TT showed no signs of failure or loosening. Three MC failed already after 26 cycles, 1510 cycles or 2144 cycles. The TT showed always a lower mean displacement. In the subsequent pull-out tests, the remaining mean fixation strength of the MC (449.6 ± 298.9 N) was slightly higher compared to the mean pull-out force of the CBT (401.2 ± 261.4 N). However, MC (714.5 ± 488.0 N) were inferior to TT (990.2 ± 451.9 N).ConclusionThe current study demonstrated that cement-augmented TT have the best fatigue and pull-out characteristics in osteoporotic lumbar vertebrae, followed by the MC and CBT. MC represent a promising alternative in osteoporotic bone if cement augmentation should be avoided. Using the patient-specific placement guide contributes to the improvement of screws' biomechanical properties.

Dataset Information

Evaluation of an Injectable Biphasic Calcium Sulfate/Hydroxyapatite Cement for the Augmentation of Fenestrated Pedicle Screws in Osteoporotic Vertebrae: A Biomechanical Cadaver Study.

Publications

Evaluation of an Injectable Biphasic Calcium Sulfate/Hydroxyapatite Cement for the Augmentation of Fenestrated Pedicle Screws in Osteoporotic Vertebrae: A Biomechanical Cadaver Study.

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