Dataset Information

Standalone lordotic endoscopic wedge lumbar interbody fusion (LEW-LIF™) with a threaded cylindrical peek cage: report of two cases.

ABSTRACT: We report two cases of a standalone lordotic endoscopic wedge lumbar interbody fusion (LEW-LIF™) with a stress-neutral non-expandable cylindrical threaded polyether ether ketone (PEEK) interbody fusion implant. Patients underwent full-endoscopic transforaminal decompression and fusion for symptomatic lateral recess stenosis due to disc herniation, and hypertrophy of the facet joint complex and ligamentum flavum and no more than grade I spondylolisthesis. Lumbar interbody fusion with cages traditionally calls for posterior supplemental fixation with pedicle screws for added stability. A more simplified version of lumbar decompression and fusion without pedicle screws would allow treating patients suffering from stenosis and instability induced sciatica-type low back and leg pain in an outpatient ambulatory surgery center setting (ASC). This would realize a significant reduction in cost as well as the burden to the patient with decreased postoperative pain and earlier return to function. A 62-year-old female patient had surgery at L4/5 for a 6-year history of worsening right sided sciatica-type leg- and low back pain. Another 79-year-old female had the same surgical management at L4/5 for a 5-year history of unrelenting left-sided spondylolisthesis-related symptoms. Both patients had an uneventful postoperative course until the last available follow-up of 24 weeks with greater than 60% VAS and Oswestry disability index (ODI) reductions. There was no evidence of implant expulsion, subsidence, or postoperative instability. We concluded that standalone outpatient lumbar transforaminal endoscopic interbody fusion with a non-expandable threaded cylindrical cage is feasible, and favorable clinical outcomes provide proof of concept to study long-term clinical outcomes in larger groups of patients.

SUBMITTER: Ramirez Leon JF

PROVIDER: S-EPMC7063321 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Standalone lordotic endoscopic wedge lumbar interbody fusion (LEW-LIF™) with a threaded cylindrical peek cage: report of two cases.

Ramírez León Jorge Felipe JF Ardila Álvaro Silva ÁS Rugeles Ortíz José Gabriel JG Martínez Carolina Ramírez CR Alonso Cuéllar Gabriel Oswaldo GO Infante Jefferson J Lewandrowski Kai-Uwe KU

Journal of spine surgery (Hong Kong) 20200101 Suppl 1

We report two cases of a standalone lordotic endoscopic wedge lumbar interbody fusion (LEW-LIF™) with a stress-neutral non-expandable cylindrical threaded polyether ether ketone (PEEK) interbody fusion implant. Patients underwent full-endoscopic transforaminal decompression and fusion for symptomatic lateral recess stenosis due to disc herniation, and hypertrophy of the facet joint complex and ligamentum flavum and no more than grade I spondylolisthesis. Lumbar interbody fusion with cages tradit ...[more]

PMID: 32195434

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Project description:We report a case of subsidence induced recurrence of unilateral L5 and S1 radiculopathy six months following a successful staged two-level endoscopic standalone lumbar interbody fusion using the VARILIF-L™ device. The patient was a 64-year-old female who first underwent outpatient endoscopic fusion L4/5 for failed non-operative care of Grade I spondylolisthesis. Within 11 months from the L4/5 index procedure, she developed symptomatic adjacent segment disease stemming from the L5/S1 level. A preoperative computed tomography before the planned L5/S1 endoscopic standalone VARILIF™ fusion 15 months following her L4/5 VARILIF™ procedure revealed fusion at the L4/5 level with minimal subsidence of the VARILIF-L™ implant, and advanced degeneration of the L5/S1 motion segment with lateral recess and foraminal stenosis, reduced posterior disc height, and vacuum disc. The patient underwent uneventful L5/S1 endoscopic standalone fusion using the VARILIF-L™ implant with successful clinical outcome and resolution of back and leg symptoms. Six months after the second endoscopic L5/S1 VARILIF™ procedure she developed recurrent L5 and S1 radiculopathy. Computed tomography showed significant implant subsidence and formation of a large soft tissue bulge on the approach side behind the interbody fusion cage. The subsidence induced subsidence and loss of posterior disc height and the associated recurrence of nerve root compression of the traversing S1 and exiting L5 nerve root. The recurrent radiculopathy was eventually treated with another transforaminal endoscopic decompression which included a more generous foraminoplasty with resection of the remaining superior articular process including a partial S1 pediculectomy and additional resection of the posterior annulus as well as scar and bony tissue that had formed within the axillary hidden zone of Macnab. We concluded that recurrent radiculopathy might occur after standalone lumbar transforaminal endoscopic interbody fusion with an expandable threaded cylindrical cage as a result of vertical and angular subsidence.

Project description:ObjectivePrevious studies have confirmed that the nanohydroxyapatite/polyamide-66 (n-HA/PA66) cage is an ideal alternative material for degenerative lumbar disease (DLD) comparable to the polyether ether ketone (PEEK) cage due to its similar radiographic fusion, subsidence rate, and clinical results. However, these studies were restricted to one-level surgery. The aim of this study was to analyze the long-term clinical and radiologic outcomes between n-HA PA66 cage and PEEK cage for patients with multi-level degenerative lumbar diseases (DLDs).MethodsWe retrospectively reviewed all patients who underwent multi-level transforaminal lumbar interbody fusion (TLIF) from June 2010 to December 2016 with a minimum 6-year follow-up. Matched-pair analysis was performed using a 1-to-1 closest neighbor approach to match patients who received an n-HA PA66 cage with those who received a PEEK cage. Clinical outcomes and radiographic evaluations were compared between the two groups. The independent student's t-test and χ2 -test were applied to compare the differences between groups.ResultsAt the end of the propensity score matching (PSM) analysis, 48 patients from n-HA/PA66 group were matched to 48 patients in the PEEK group. No significant difference was observed in cage subsidence and bony fusion except for adjacent segment degeneration (ASD). The occurrence of ASD was 14.58% (7/48) in the n-HA/PA 66 group, which was significantly less than that in the PEEK group (33.33% [16/48]) (p = 0.031). Although the intervertebral space height (IH), segmental angle (SA) and lumbar lordosis (LL) significantly increased after surgery in both groups, there was no significant difference at any time point after surgery (p > 0.05). The visual analogue scale (VAS) and Oswestry disability index (ODI) scores significantly improved in both groups at 3m postoperative, 1y postoperative and at final follow-up. However, there were no significant differences in the VAS and ODI score at any time point (p > 0.05). The total complications and re-admission rate were not different between the two groups.ConclusionOverall, our data suggest that the outcomes of n-HA/PA66 cage group are comparable to those of the PEEK cage group, with a similar high fusion rate and low cage subsidence rate as PEEK cages, except its lower rate of ASD occurrence.

Project description:BACKGROUND:To compare standalone oblique lateral interbody fusion (OLIF) vs. OLIF combined with posterior bilateral percutaneous pedicle screw fixation (OLIF combined) for the treatment of lumbar spondylolisthesis. METHODS:This was a retrospective study of patients who underwent standalone OLIF or combined OLIF between 07/2014 and 08/2017 at two hospitals in China. Direct decompressions were not performed. Visual analog scale (VAS), Oswestry Disability Index (ODI), satisfaction rate, anterior/posterior disc heights (DH), foraminal height (FH), foraminal width (FW), cage subsidence, cage retropulsion, fusion rate, and complications were analyzed. All imaging examinations were read independently by two physicians and the mean measurements were used for analysis. RESULTS:A total of 73 patients were included: 32 with standalone OLIF and 41 with combined OLIF. The total complication rate was 25.0% with standalone OLIF and 26.8% with combined OLIF. There were no differences in VAS and ODI scores by 2?years of follow-up, but the scores were better with standalone OLIF at 1?week and 3?months (P?<?0.05). PDH and FW was smaller in the combined OLIF group compared with the standalone OLIF group before and after surgery (all P?<?0.05). There were significant differences in FH before surgery and at 1?week and 3?months between the two groups (all P?<?0.05), but the difference disappeared by 2?years (P?=?0.111). Cage subsidence occurred in 7.3% (3/41) and 7.3% (3/41) of the patients at 3 and 24?months, respectively, in the combined OLIF group, compared with 6.3% (2/32) and 15.6% (5/32), respectively, in the standalone OLIF group at the same time points (P?=?0.287). There was no cage retropulsion in both groups at 2?years. The fusion rate was 85.4%(35/41) in the combined OLIF group and 84.4% (27/32) in the standalone OLIF group at 3?months(P?=?0.669). At 24?months, the fusion rate was 100.0% in the combined OLIF group and 93.8% (30/32) in the standalone OLIF group (P?=?0.066). CONCLUSION:Standalone OLIF may achieve equivalent clinical and radiological outcomes than OLIF combined with fixation for spondylolisthesis. The rate of complications was similar between the two groups. Patients who are osteoporotic might be better undergoing combined rather than standalone OLIF. The possibilty of proof lies within a future prospective study, preferably an RCT.

Project description:Purpose:To evaluate the short-term clinical outcomes, complications, hospitalization time, and readmission rate related to day-case opening wedge high tibial osteotomy (OWHTO) with intraosseous PEEK (polyether ether ketone) implant, in the treatment of knee osteoarthritis. Methods:An observational study on patients treated with OWHTO using intraosseous PEEK implant was performed with a period of 12 months follow-up. Grade of Knee Injury and Osteoarthritis Outcome Score (KOOS) was assessed preoperatively, at 6 months, and at 12 months postoperatively. A simple t test was used to analyze the outcomes. P values <.05 were considered significant. Complications and revision surgeries were registered. Results:In the period from 2016 to 2017, a consecutive group of 40 patients (13 female, 27 male) with symptomatic medial knee osteoarthritis and varus malalignment were included in the study. The average age of the patients was 54.9 (± 7.6) years. In total, 30 (77%) patients met the criterion for minimal clinically important difference in KOOS scores. The KOOS symptoms improved from 58.1 ± 20 to 78.5 ± 16.5 (P < .0001), pain from 48.1 ± 18.2 to 78.6 ± 18.5 (P < .0001), activities of daily living from 59.0 ± 19.5 to 84.1 ± 15.2 (P < .0001), sport from 23.2 ± 17.6 to 55.6 ± 26.3 (P < .0001), and quality of life from 28.4 ± 12.8 to 61.5 ± 22.5 (P < .0001) at 1-year follow-up. The average hospitalization time at the Day Surgery Unit was 5.6 ± 0.7 hours, and 4 (10%) patients had to be readmitted to the hospital within 2 weeks postoperatively. The overall complication rate was 18%. Complications that required revision surgery were registered in 4 patients (10%), including 2 non-unions and 2 progressions of osteoarthritis. Conclusions:The day-case OWHTO with intraosseous PEEK implant was a success in 77% of the cases. The results and complications were comparable with other published studies. Despite a short hospitalization time, the readmission rate was low. Level of Evidence:IV, therapeutic case series.

Project description:BackgroundBecause of the implant-related problems with pedicle screw-based spinal instrumentations, other types of fixation have been tried in spinal arthrodesis. One such technique is the direct trans-pedicular, trans-discal screw fixation, pioneered by Grob for spondylolisthesis. The newly developed GO-LIF procedure expands the scope of the Grob technique in several important ways and adds security by means of robotic-assisted navigation. This is the first clinical trial on the GO-LIF procedure and it will assess safety and efficacy.Methods/designMulticentric prospective study with n = 40 patients to undergo single level instrumented spinal arthrodesis of the lumbar or the lumbosacral spine, based on a diagnosis of: painful disc degeneration, painful erosive osteochondrosis, segmental instability, recurrent disc herniation, spinal canal stenosis or foraminal stenosis. The primary target criteria with regards to safety are: The number, severity and cause of intra- and perioperative complications. The number of significant penetrations of the cortical layer of the vertebral body by the implant as recognized on postoperative CT. The primary target parameters with regards to feasibility are: Performance of the procedure according to the preoperative plan. The planned follow-up is 12 months and the following scores will be evaluated as secondary target parameters with regards to clinical improvement: VAS back pain, VAS leg pain, Oswestry Disability Index, short form - 12 health questionnaire and the Swiss spinal stenosis questionnaire for patients with spinal claudication. The secondary parameters with regards to construct stability are visible fusion or lack thereof and signs of implant loosening, implant migration or pseudarthrosis on plain and functional radiographs.DiscussionThis trial will for the first time assess the safety and efficacy of guided oblique lumbar interbody fusion. There is no control group, but the results, the outcome and the rate of any complications will be analyzed on the background of the literature on instrumented spinal fusion. Despite its limitations, we expect that this study will serve as the key step in deciding whether a direct comparative trial with another fusion technique is warranted.Trial registrationClinical Trials NCT00810433.

Project description:BackgroundPolyetheretherketone (PEEK) cages have been widely used in the treatment of lumbar degenerative disc disorders, and show good clinical results. Still, complications such as subsidence and migration of the cage are frequently seen. A lack of osteointegration and fibrous tissues surrounding PEEK cages are held responsible. Ceramic implants made of silicon nitride show better biocompatible and osteoconductive qualities, and therefore are expected to lower complication rates and allow for better fusion.Purpose of this study is to show that fusion with the silicon nitride cage produces non-inferior results in outcome of the Roland Morris Disability Questionnaire at all follow-up time points as compared to the same procedure with PEEK cages.Methods/designThis study is designed as a double blind multi-center randomized controlled trial with repeated measures analysis. 100 patients (18-75 years) presenting with symptomatic lumbar degenerative disorders unresponsive to at least 6 months of conservative treatment are included. Patients will be randomly assigned to a PEEK cage or a silicon nitride cage, and will undergo a transforaminal lumbar interbody fusion with pedicle screw fixation. Primary outcome measure is the functional improvement measured by the Roland Morris Disability Questionnaire. Secondary outcome parameters are the VAS leg, VAS back, SF-36, Likert scale, neurological outcome and radiographic assessment of fusion. After 1 year the fusion rate will be measured by radiograms and CT. Follow-up will be continued for 2 years. Patients and clinical observers who will perform the follow-up visits will be blinded for type of cage used during follow-up. Analyses of radiograms and CT will be performed independently by two experienced radiologists.DiscussionIn this study a PEEK cage will be compared with a silicon nitride cage in the treatment of symptomatic degenerative lumbar disc disorders. To our knowledge, this is the first randomized controlled trial in which the silicon nitride cage is compared with the PEEK cage in patients with symptomatic degenerative lumbar disc disorders.Trial registrationNCT01557829.

Dataset Information

Standalone lordotic endoscopic wedge lumbar interbody fusion (LEW-LIF™) with a threaded cylindrical peek cage: report of two cases.

Publications

Standalone lordotic endoscopic wedge lumbar interbody fusion (LEW-LIF™) with a threaded cylindrical peek cage: report of two cases.

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