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Expandable Polyaryl-Ether-Ether-Ketone Spacers for Interbody Distraction in the Lumbar Spine.

ABSTRACT: Study Design Retrospective case series. Objective StaXx XD (Spine Wave, Inc., Shelton, CT, United States) is an expandable polyaryl-ether-ether-ketone (PEEK) wafer implant utilized in the treatment of lumbar degenerative disease. PEEK implants have been successfully used as interbody devices. Few studies have focused on expandable PEEK devices. The aim of the current study is to determine the radiographic and clinical outcome of expandable PEEK cages utilized for transforaminal lumbar interbody fusion in patients with lumbar degenerative diseases. Methods Forty-nine patients who underwent lumbar interbody fusion with implantation of expandable PEEK cages and posterior instrumentation were included. The clinical outcome was evaluated using the visual analog scale (VAS) and the Oswestry Disability Index (ODI). Radiographic parameters including disk height, foraminal height, listhesis, local disk angle of the index level/levels, regional lumbar lordosis, and graft subsidence were measured preoperatively, postoperatively, and at latest follow-up. Results At an average follow-up of 19.3 months, the minimum clinically important difference for the ODI and VAS back, buttock, and leg were achieved in 64, 52, 58, and 52% of the patients, respectively. There was statistically significant improvement in VAS back (6.42 versus 3.11, p < 0.001), VAS buttock (4.66 versus 1.97, p = 0.002), VAS leg (4.55 versus 1.96, p < 0.001), and ODI (21.7 versus 12.1, p < 0.001) scores. There was a significant increase in the average disk height (6.49 versus 8.18 mm, p = 0.037) and foraminal height (15.6 versus 18.53 mm, p = 0.0001), and a significant reduction in the listhesis (5.13 versus 3.15 mm, p = 0.005). The subsidence of 0.66 mm (7.4%) observed at the latest follow-up was not significant (p = 0.35). Conclusions Midterm results indicate that expandable PEEK spacers can effectively and durably restore disk and foraminal height and improve the outcome without significant subsidence.

SUBMITTER: Alimi M

PROVIDER: S-EPMC4472284 | biostudies-other | 2015 Jun

REPOSITORIES: biostudies-other

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Project description:BackgroundLumbar interbody fusion is among the most common types of spinal surgery performed. Over time, the term has evolved to encompass a number of different approaches to the intervertebral space, as well as differing implant materials. Questions remain over which approaches and materials are best for achieving fusion and restoring disc height.Questions/purposesWe reviewed the literature on the advantages and disadvantages of various methods and devices used to achieve and augment fusion between the disc spaces in the lumbar spine.MethodsUsing search terms specific to lumbar interbody fusion, we searched PubMed and Google Scholar and identified 4993 articles. We excluded those that did not report clinical outcomes, involved cervical interbody devices, were animal studies, or were not in English. After exclusions, 68 articles were included for review.ResultsPosterior approaches have advantages, such as providing 360° support through a single incision, but can result in retraction injury and do not always restore lordosis or correct deformity. Anterior approaches allow for the largest implants and good correction of deformities but can result in vascular, urinary, psoas muscle, or lumbar plexus injury and may require a second posterior procedure to supplement fixation. Titanium cages produce improved osteointegration and fusion rates but also increase subsidence caused by the stiffness of titanium relative to bone. Polyetheretherketone (PEEK) has an elasticity closer to that of bone and shows less subsidence than titanium cages, but as an inert compound PEEK results in lower fusion rates and greater osteolysis. Combination PEEK-titanium coating has not yet achieved better results. Expandable cages were developed to increase disc height and restore lumbar lordosis, but the data on their effectiveness have been inconclusive. Three-dimensionally (3D)-printed cages have shown promise in biomechanical and animal studies at increasing fusion rates and reducing subsidence, but additive manufacturing options are still in their infancy and require more investigation.ConclusionsAll of the approaches to spinal fusion have plusses and minuses that must be considered when determining which to use, and newer-technology implants, such as PEEK with titanium coating, expandable, and 3D-printed cages, have tried to improve upon the limitations of existing grafts but require further study.

Project description:ObjectiveTo compare the early radiographic and clinical outcomes of expandable uniplanar versus biplanar interbody cages used for single-level minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF).MethodsA retrospective review of 1-level MIS-TLIFs performed with uniplanar and biplanar polyetheretherketone cages was performed. Radiographic measurements were performed on radiographs taken preoperatively, at 6-week follow-up, and 1-year follow-up. Oswestry Disability Index (ODI) and visual analogue scale (VAS) for back and leg at 3-month and 1-year follow-up.ResultsA total of 93 patients (41 uniplanar, 52 biplanar) were included. Both cage types provided significant postoperative improvements in anterior disc height, posterior disc height, and segmental lordosis at 1 year. No significant differences in cage subsidence rates were found between uniplanar (21.9%) and biplanar devices (32.7%) at 6 weeks (odds ratio, 2.015; 95% confidence interval, 0.651-6.235; p = 0.249) with no additional instances of subsidence at 1 year. No significant differences in the magnitude of improvements based on ODI, VAS back, or VAS leg at 3-month or 1-year follow-up between groups and the proportion of patients achieving the minimal clinically important difference in ODI, VAS back, or VAS leg at 1 year were not statistically significantly different (p > 0.05). Finally, there were no significant differences in complication rates (p = 0.283), 90-day readmission rates (p = 1.00), revision surgical procedures (p = 0.423), or fusion rates at 1 year (p = 0.457) between groups.ConclusionBiplanar and uniplanar expandable cages offer a safe and effective means of improving anterior disc height, posterior disc height, segmental lordosis, and patient-reported outcome measures at 1 year postoperatively. No significant differences in radiographic outcomes, subsidence rates, mean subsidence distance, 1-year patient-reported outcomes, and postoperative complications were noted between groups.

Project description:BackgroundTransforaminal lumbar interbody fusion (TLIF) is an effective surgery for lumbar degenerative disease. However, this fusion technique requires resection of inferior facet joint to provide access for superior facet joint resection, which results in reduced lumbar spinal stability and unnecessary trauma. We have previously developed extraforaminal lumbar interbody fusion (ELIF) that can avoid back muscle injury with direct nerve root decompression. This study aims to show that ELIF enhances lumbar spinal stability in comparison to TLIF by comparing lumbar spinal stability of L4-L5 range of motion (ROM) on 12 cadaveric spine specimens after performing TLIF or ELIF.Methods12 cadaveric spine specimens were randomly divided and treated in accordance with the different internal fixations, including ELIF with a unilateral pedicle screw (ELIF+UPS), TLIF with a unilateral pedicle screw (TLIF+UPS), TLIF with a bilateral pedicle screw (TLIF+BPS), ELIF with a unilateral pedicle screw and translaminar facet screw (ELIF+UPS+TLFS) and ELIF with a bilateral pedicle screw (ELIF+BPS). The treatment groups were exposed to a 400-N load and 6 N·m movement force to calculate the angular displacement of L4-L5 during anterior flexion, posterior extension, lateral flexion and rotation operation conditions.ResultsThe ROM in ELIF+UPS group was smaller than that of TLIF+UPS group under all operating conditions, with the significant differences in left lateral flexion and right rotation by 36.15% and 25.97% respectively. The ROM in ELIF+UPS group was higher than that in TLIF+BPS group. The ROM in the ELIF+UPS+TLFS group was much smaller than that in the ELIF+UPS group, but was not significantly different than that in the TLIF+BPS group.ConclusionsDespite that TLIF+BPS has great stability, which can be comparable by that of ELIF+UPS. Additionally, ELIF stability can be further improved by using translaminar facet screws without causing more tissue damage to patient.

Project description:ObjectiveTo observe the clinical and radiological effect of crenel lateral interbody fusion (CLIF) procedure in the management of lumbar spine adjacent segment degenerative (ASD).MethodsThirty-seven patients with lumbar spine ASD who underwent the CLIF procedure between June 2018 and December 2019 were included in the study. There were 13 males and 24 females, with a mean age of 64.30 ± 5.92 years. The VAS score of the back (VAS_Back) and legs (VAS_Leg), Oswestry Disability Index (ODI) score, the height of the intervertebral space (HIS), the height of the intervertebral foramen (HIF), the cross-sectional area (CSA) of the vertebral canal, segmental lordosis (SL), and lumbar lordosis (LL) were recorded before the operation, 2 weeks after the operation, 3 months after the operation, and at the last follow-up respectively. Clinical and radiological outcomes before and after the surgery were compared, and correlation and regression analyses were performed.ResultsThere were no vascular and nerve-related complications during the operation. The average follow-up time was 16.63 ± 4.24 months. The median of both VAS_Back and VAS_Leg was 7 before surgery and 1 at the last follow-up. Meanwhile, the average preoperative ODI score, HIS, HIF, CSA of the vertebral canal, LL, and SL was (67.48 ± 7.17) %, (4.80 ± 0.73) mm, (12.95 ± 2.07) mm, (59.52 ± 9.22) mm2 , (37.22 ± 5.92)° and (4.78 ± 1.99)°, respectively. At the final follow-up, ODI score, HIS, HIF, CSA of the vertebral canal, LL, and SL was (7.07 ± 2.66) %, (9.44 ± 0.61) mm, (17.30 ± 1.90) mm, (70.49 ± 8.95) mm2 , (44.67 ± 6.38)° and (13.44 ± 3.27)°, respectively. In the VAS_Back, VAS_Leg, ODI score, LL, SL, HIS, HIF, and CSA of the vertebral canal, the difference between preoperative and 2 weeks after the operation, 3 months after the operation, and the last follow-up were statistically significant (P < 0.05). However, the difference was not statistically significant between each time point after the operation in the CSA of the vertebral canal, LL, and SL (P > 0.05). Nonetheless, the difference was statistically significant in ODI between each time point after the operation (P < 0.05). VAS_Leg was associated with HIS, HIF, and CSA of the vertebral canal, while LL and SL were risk factors for low back pain.ConclusionCrenel lateral interbody fusion is an effective procedure in the management of lumbar ASD. Not only was the postoperative swift recovery due to minimal invasion, but also adequate LL and SL were achievable.

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Expandable Polyaryl-Ether-Ether-Ketone Spacers for Interbody Distraction in the Lumbar Spine.

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