Transforaminal lumbar interbody fusion using a novel minimally invasive expandable interbody cage: patient-reported outcomes and radiographic parameters

Author(s):  
Josha Woodward ◽  
Hani Malone ◽  
Christopher D. Witiw ◽  
John Paul G. Kolcun ◽  
Lacin Koro ◽  
...  

OBJECTIVE The goal of this study was to evaluate the clinical and radiographic outcomes of a novel multidirectional in situ expandable minimally invasive surgery (MIS) transforaminal lumbar interbody fusion (TLIF) cage. METHODS A retrospective analysis of 69 consecutive patients undergoing a 1- or 2-level MIS TLIF using an expandable cage was performed over a 2-year period. Standard MIS techniques with pedicle screw fixation were used in all cases. Upright lateral dynamic flexion/extension radiographs were reviewed prior to and at 1 year after surgery. Clinical metrics included numeric rating scale for back and leg pain, Oswestry Disability Index, and the SF-12 and VR-12 physical and mental health surveys. Radiographic parameters included anterior and posterior disc height, neuroforaminal height, spondylolisthesis, segmental lordosis, lumbar lordosis, and fusion rate. RESULTS A total of 69 patients representing 75 operative levels met study inclusion criteria. The mean patient age at surgery was 63.4 ± 1.2 years, with a female predominance of 51%. The average radiographic and clinical follow-ups were 372 and 368 days, respectively. A total of 63 patients (91%) underwent 1-level surgery and 6 patients (9%) underwent 2-level surgery. Significant reductions of numeric rating scale scores for back and leg pain were observed—from 6.1 ± 0.7 to 2.5 ± 0.3 (p < 0.0001) and 4.9 ± 0.6 to 1.9 ± 0.2 (p < 0.0001), respectively. A similar reduction in Oswestry Disability Index from 38.0 ± 4.6 to 20.0 ± 2.3 (p < 0.0001) was noted. Likewise, SF-12 and VR-12 scores all showed statistically significant improvement from baseline (p < 0.001). The mean anterior and posterior disc heights improved from 8.7 ± 1.0 mm to 13.4 ± 1.5 mm (p = 0.0001) and 6.5 ± 0.8 mm to 9.6 ± 1.1 mm (p = 0.0001), respectively. Neuroforaminal height improved from 17.6 ± 2.0 mm to 21.9 ± 2.5 mm (p = 0.0001). When present, spondylolisthesis was, on average, reduced from 4.3 ± 0.5 mm to 1.9 ± 0.2 mm (p = 0.0001). Lumbar lordosis improved from 47.8° ± 5.5° to 58.5° ± 6.8° (p = 0.2687), and no significant change in segmental lordosis was observed. The overall rate of radiographic fusion was 93.3% at 1 year. No perioperative complications requiring operative revision were encountered. CONCLUSIONS In this series of MIS TLIFs, use of this novel interbody cage was shown to be safe and effective. Significant improvements in pain and disability were observed. Effective and durable restoration of disc height and neuroforaminal height and reduction of spondylolisthesis were obtained, with concurrent gains in lumbar lordosis. Taken together, this device offers excellent clinical and radiographic outcomes via an MIS approach.

Neurosurgery ◽  
2009 ◽  
Vol 64 (1) ◽  
pp. 115-121 ◽  
Author(s):  
Jee-Soo Jang ◽  
Sang-Ho Lee ◽  
Jung Mok Kim ◽  
Jun-Hong Min ◽  
Kyung-Mi Han ◽  
...  

Abstract OBJECTIVE To analyze pre- and postoperative x-rays of sagittal spines and to review the surgical results of 21 patients with lumbar degenerative kyphosis whose spines were sagittally well compensated by compensatory mechanisms but who continued to suffer from intractable back pain METHODS We performed a retrospective review of 21 patients treated with combined anterior and posterior spinal arthrodesis. Inclusion criteria were: lumbar degenerative kyphosis patients with intractable back pain and whose spines were sagittally well compensated by a compensatory mechanism, defined as a C7 plumb line to the posterior aspect of the L5–S1 disc of less than 5 cm. Outcome variables included: radiographic measures of preoperative, postoperative, and follow-up films; clinical assessment using the mean Numeric Rating Scale, Oswestry Disability Index, and Patient Satisfaction Index; and a review of postoperative complications. RESULTS All patients were female (mean age, 64.5 years; age range, 50–74 years). The mean preoperative sagittal imbalance was 19.5 (± 17.6) mm, which improved to −15.8 (± 22.2) mm after surgery. Mean lumbar lordosis was 13.2 degrees (± 15.3) before surgery and increased to 38.1 degrees (± 14.4) at follow-up (P &lt; 0.0001). Mean thoracic kyphosis was 5.5 degrees (± 10.2) before surgery and increased to 18.9 degrees (± 12.4) at follow-up (P &lt; 0.0001). Mean sacral slopes were 12.9 degrees (± 11.1) before surgery and increased to 26.3 degrees (± 9.6) at follow-up (P &lt; 0.0001). The mean Numeric Rating Scale score improved from 7.8 (back pain) and 8.1 (leg pain) before surgery to 3.0 (back pain) and 2.6 (leg pain) after surgery (P &lt; 0.0001). The mean Oswestry Disability Index scores improved from 56.2% before surgery to 36.7% after surgery (P &lt; 0.0001). In 18 (85.5%) of 21 patients, satisfactory outcomes were demonstrated by the time of the last follow-up assessment. CONCLUSION This study shows that even lumbar degenerative kyphosis patients with spines that are sagittally well compensated by compensatory mechanisms may suffer from intractable back pain and that these patients can be treated effectively by the restoration of lumbar lordosis.


2019 ◽  
Vol 27 (3) ◽  
pp. 230949901986946
Author(s):  
Kristian Høy ◽  
Blazej Grycel ◽  
Thomas Andersen ◽  
Cody Bünger

Background: Transforaminal lumbar interbody fusion (TLIF) is presently the most used method to achieve lumbar interbody fusion worldwide. The special preparation and cage insertion imply a risk of an undesirable side effect in the form of residual neurogenic pain. This issue has not been investigated prior in a randomized clinical trial (RCT) set up. Aim: To test whether TLIFs had a higher incidence of leg pain in comparison to a common instrumented posterolateral fusion (PLF) and to test whether a higher occurrence of leg pain on the ipsilateral side in the TLIF group was present. Methods: One hundred patients included in a RCT comparing TLIF and PLF fulfilled pain drawings and numeric rating scale (NRS) scale from 0 to 10 preoperatively, after 1 year, and after 2 years. Difference in pain appearance, type, localization, and intensity was compared between groups. Results: A slightly higher number of patients in the TLIF group reported leg pain at 2 years follow-up: no leg pain, 47% (PLF) and 37% (TLIF); unilateral leg pain, 31% (PLF) and 25% (TLIF); bilateral leg pain, 22% (PLF) and 37% (TLIF), p = 0.270. Numbness and pins and needles on the anterior aspect of the lower leg were marked by 10% and 12% of TLIF patients compared to 6% and 4% in PLF patients p = 0.498/0.197. The ipsilateral side of cage insertion in the TLIF group was not a place for new leg pain compared to the contralateral side. Conclusion: The special surgical preparation used in TLIFs does not result in the development of new ipsilateral leg pain. However, a higher percentage of the patients in the TLIF group had new leg pain in comparison to PLF after 2 years.


Neurosurgery ◽  
2015 ◽  
Vol 77 (1) ◽  
pp. 113-118 ◽  
Author(s):  
Toru Sasamori ◽  
Kazutoshi Hida ◽  
Toshiya Osanai ◽  
Shunsuke Yano ◽  
Toshitaka Seki ◽  
...  

Abstract BACKGROUND: Chronic pain due to spinal dural arteriovenous fistulae (SDAVF) during follow-up is a serious issue because it can affect patients' quality of life. The severity of posttreatment chronic leg pain in patients with SDAVF is unclear. OBJECTIVE: To investigate the prevalence, severity, and characteristics of chronic leg pain in patients with SDAVF and to examine the clinical factors associated with chronic pain. METHODS: We conducted a survey of their chronic posttreatment leg pain in 49 SDAVF patients. It consisted of a numeric rating scale and a neuropathic pain symptom inventory (NPSI). Of the 49 patients, 32 (65.3%) completed the questionnaire. There were 24 males and 8 females whose mean age was 69.1 years. The mean follow-up period was 86.3 months. RESULTS: Chronic leg pain was reported by 26 (81.3%) of 32 patients; 14 experienced pain before treatment and 12 had new-onset posttreatment pain. The pain was reported as moderate to severe by 21 (80.8%) of 26 patients; the mean numeric rating scale and NPSI scores were 6.0 ± 2.3 and 17.4 ± 10.3, respectively. The NPSI subscores were significantly higher for spontaneous pain and paresthesia/dysesthesia than for paroxysmal pain. We found no significant clinical factors related to chronic posttreatment pain; on magnetic resonance imaging scans we identified spinal cord atrophy in 8 patients with chronic pain. CONCLUSION: Most of our SDAVF patients reported moderate to severe chronic leg pain characterized by spontaneous pain and paresthesia/dysesthesia. Spinal cord atrophy on magnetic resonance imaging scans was a characteristic in patients with chronic pain.


Neurosurgery ◽  
2011 ◽  
Vol 69 (6) ◽  
pp. 1181-1187 ◽  
Author(s):  
Kai-Ming G. Fu ◽  
Prashant Rhagavan ◽  
Christopher I. Shaffrey ◽  
Daniel R. Chernavvsky ◽  
Justin S. Smith

Abstract BACKGROUND Management approaches for adult scoliosis are primarily based on adults with idiopathic scoliosis and extrapolated to adults with degenerative scoliosis. However, the often substantially, but poorly defined, greater degenerative changes present in degenerative scoliosis impact the management of these patients. OBJECTIVE To assess the prevalence, severity, and impact of canal and foraminal stenosis in adults with degenerative scoliosis seeking operative treatment. METHODS A prospectively collected database of adult patients with deformity was reviewed for consecutive patients with degenerative scoliosis seeking surgical treatment, without prior corrective surgery. Patients completed the Oswestry Disability Index, SF-12, Scoliosis Research Society 22 questionnaire, and a pain numeric rating scale (0–10). Based on MRI or CT myelogram, the central canal and foraminae from T6 to S1 were graded for stenosis (normal or minimal/mild/moderate/severe). RESULTS Thirty-six patients were included (mean age, 68.9 years; range, 51–85). The mean leg pain numeric rating scale was 6.5, and the mean Oswestry Disability Index score was 53.2. At least 1 level of severe foraminal stenosis was identified in 97% of patients; 83% had maximum foraminal stenosis in the curve concavity. All but 1 patient reported significant radicular pain, including 78% with discrete and 19% with multiple radiculopathies. Of those with discrete radiculopathies, 76% had pain corresponding to areas of the most severe foraminal stenosis, and 24% had pain corresponding to areas of moderate stenosis. CONCLUSION Significant foraminal stenosis was prevalent in patients with degenerative scoliosis, and the distribution of leg pain corresponded to levels of moderate or severe foraminal stenosis. Failure to address symptomatic foraminal stenosis when surgically treating adult degenerative scoliosis may negatively impact clinical outcomes.


2018 ◽  
Vol 44 (1) ◽  
pp. E8 ◽  
Author(s):  
Lara W. Massie ◽  
Hesham Mostafa Zakaria ◽  
Lonni R. Schultz ◽  
Azam Basheer ◽  
Morenikeji Ayodele Buraimoh ◽  
...  

OBJECTIVEThe inability to significantly improve sagittal parameters has been a limitation of minimally invasive surgery for transforaminal lumbar interbody fusion (MIS TLIF). Traditional cages have a limited capacity to restore lordosis. This study evaluates the use of a crescent-shaped articulating expandable cage (Altera) for MIS TLIF.METHODSThis is a retrospective review of 1- and 2-level MIS TLIF. Radiographic outcomes included differences in segmental and lumbar lordosis, disc height, evidence of fusion, and any endplate violations. Clinical outcomes included the numeric rating scale for leg and back pain and the Oswestry Disability Index (ODI) for low-back pain.RESULTSThirty-nine patients underwent single-level MIS TLIF, and 5 underwent 2-level MIS TLIF. The mean age was 63.1 years, with 64% women. On average, spondylolisthesis was corrected by 4.3 mm (preoperative = 6.69 mm, postoperative = 2.39 mm, p < 0.001), the segmental angle was improved by 4.94° (preoperative = 5.63°, postoperative = 10.58°, p < 0.001), and segmental height increased by 3.1 mm (preoperative = 5.09 mm, postoperative = 8.19 mm, p < 0.001). At 90 days after surgery the authors observed the following: a smaller postoperative sagittal vertical axis was associated with larger changes in back pain at 90 days (r = −0.558, p = 0.013); a larger decrease in spondylolisthesis was associated with greater improvements in ODI and back pain scores (r = −0.425, p = 0.043, and r = −0.43, p = 0.031, respectively); and a larger decrease in pelvic tilt (PT) was associated with greater improvements in back pain (r = −0.548, p = 0.043). For the 1-year PROs, the relationship between the change in PT and changes in ODI and numeric rating scale back pain were significant (r = 0.612, p = 0.009, and r = −0.803, p = 0.001, respectively) with larger decreases in PT associated with larger improvements in ODI and back pain. Overall for this study there was a 96% fusion rate.Fourteen patients were noted to have endplate violation on intraoperative fluoroscopy during placement of the cage. Only 3 of these had progression of their subsidence, with an overall subsidence rate of 6% (3 of 49) visible on postoperative CT.CONCLUSIONSThe use of this expandable, articulating, lordotic, or hyperlordotic interbody cage for MIS TLIF provides a significant restoration of segmental height and segmental lordosis, with associated improvements in sagittal balance parameters. Patients treated with this technique had acceptable levels of fusion and significant reductions in pain and disability.


2021 ◽  
Vol 15 (1) ◽  
pp. 35-40
Author(s):  
Kyriakos Kitsopoulos ◽  
Bernd Wiedenhoefer ◽  
Stefan Hemmer ◽  
Christoph Fleege ◽  
Mohammad Arabmotlagh ◽  
...  

Background: Compared with static cages, expandable cages for Transforaminal Lumbar Interbody Fusion (TLIF), are thought to require less posterior bony removal and nerve root retraction. They may allow the creation of a greater lordotic angle and lordosis restoration. Objective: This study investigated whether TLIF using an expandable lordotic interbody cage facilitates an improvement in both segmental lordosis and the restoration of intradiscal height. Methods: A total of 32 patients with 40 operated segments underwent TLIF surgery for lumbar degenerative disc disease and were consecutively included in this prospective observational study. Of those patients, 25 received monosegmental treatment, six were treated bisegmentally, and one was treated trisegmentally. All patients were assessed clinically and radiographically preoperatively, as well as one week, six months, and two years postoperatively. Results: Two patients required revision for screw loosening and pseudarthrosis. In four patients, the endplate was violated intraoperatively due to cage placement. Postoperatively, cage subsidence was observed in four patients. Significant improvement in the mean degree of spondylolisthesis was noted at the two-year mark. Mean segmental lordosis improved postoperatively. A significant increase in mean disc height of the treated segment was also found. Overall, with the exception of pain, no significant clinical or radiographic changes were reported between the first postoperative week and the two-year year follow-up mark. The mean pain, functional, and quality of life outcomes improved significantly from the preoperative to postoperative period, with no deterioration between six months and two years. Conclusion: This study demonstrates that favorable outcomes can be achieved by using an expandable titanium cage in TLIF procedures.


2020 ◽  
Author(s):  
Hyeun-Sung Kim ◽  
Harshavardhan Dilip Raorane ◽  
Pang Hung Wu ◽  
Dong Hwa Heo ◽  
Yeon Jin Yi ◽  
...  

Abstract Background: The implement of endoscopic spinal surgery into degenerative spinal disease has minimized the requirement of fusion procedures. However, it is still necessary to develop endoscopic spine surgery in certain patients requiring fusion such as instability. We performed a full-endoscopic transforaminal lumbar interbody fusion(eTLIF) through a conventional paraspinal approach. The feasibility of procedure and early outcome were evaluated.Materials and Methods: eighteen consecutive patients with degenerative lumbar disease underwent eTLIF through a conventional paraspinal approach. Their clinical outcomes were evaluated with visual analog scale(VAS) leg pain score, Oswestry Disability Index(ODI) and the MacNab's criteria; radiological outcome measured with segmental lordosis, global lumbar lordosis, disc height on plain radiograph and percentage of potential fusion mass on CT scan at pre-operative, post-operative and final follow up period. intra operative and post-operative complications noted.Results: Mean age was 63. 71 years and Mean follow-up periods was 7.78 months. According to the level, L2-3 (1 case), L3-4 (4 cases), L4-5 (13 cases) and L5-S1 (2 cases). In the X-ray result, mean segmental lordosis angle(SLA) improved in pre-operative/post-operative/follow-up period 9.87±2.74 degree/ 11.79±3.74 degree/ 10.56±3.69 degree (p > 0.01); mean lumbar lordosis angle(LLA) improved 37.1±7.04 degree/ 39.2±7.13 degree/ 35.7±7.25 degree(p > 0.01). Mean preoperative disc height(DH) improved from 8.97±1.49 mm/ 12.34±1.39 mm/ 11.44±1.98 mm (p < 0.01). In the CT result, Average percentage of fusion mass was 42.61%. VAS was improved significantly, 7.67 / 3.39 / 2.5 and ODI was improved significantly, 74.9 / 34.56 / 27.76 by each preoperative / postoperative / final follow-up. In the clinical result, excellent was 5 cases and good was 13 cases. Conclusion: According to the results of this study, eTLIF was competent enough to perform as open TLIF. and good results were obtained in the form of endplate preservation, disc height restoration, minimal blood loss and post-operative pain with early mobilization. In addition, the fusion volume including the cage and the bone graft material occupies 40% to 50% of disc space is expected to give sufficient fusion by using 3D printed cages which gives the high fusion rate. In conclusion, eTLIF is considered to be a viable surgical procedure.


2021 ◽  
pp. rapm-2020-102238
Author(s):  
Jonathan M Hagedorn ◽  
Timothy R Deer ◽  
Nicholas C Canzanello ◽  
Stephen M Covington ◽  
Darrell R Schroeder ◽  
...  

IntroductionSpinal cord stimulation is frequently used for the treatment of intractable chronic pain conditions. Trialing of the spinal cord stimulator device is recommended to assess the patient’s response to neurostimulation before permanent implantation. The trial response is often assessed by Numeric Rating Scale changes and patient-reported percentage pain improvement. Using number rating scale changes between prespinal and postspinal cord stimulation trial, a calculated percentage pain improvement can be obtained. The aim of this study was to assess the difference between calculated and patient-reported percentage improvement in pain scale during spinal cord stimulation trials.MethodsThis study was a retrospective single center review of all spinal cord stimulation trials from January 1 2017 to July 1 2019. A total of 174 patients were included. The paired t-test was used to compare numeric pain scores obtained prestimulation versus poststimulation. The mean difference between methods (patient-reported minus calculated) was compared with zero using the 1-sample t-test. Lin’s concordance correlation coefficient was computed with a 95% CI, calculated using Fisher z-transformation; and a bootstrapping approach was used to compare the concordance correlation coefficient between groups. In all cases, two-tailed tests were used with p<0.05 considered statistically significant.ResultsBased on prestimulation and poststimulation numeric rating scale scores, the mean±SD calculated percentage improvement in pain scale was 54±28. The mean±SD patient-reported percentage improvement in pain scale was 59±25. The overall 95% limits of agreement for the two methods are −30% to +41%. The overall concordance correlation coefficient was 0.76 (95% CI 0.69 to 0.81).ConclusionAlthough the two methods are highly correlated, there is substantial lack of agreement between patient-reported and calculated percentage improvement in pain scale, suggesting that these measures should not be used interchangeably for spinal cord stimulator trial outcome assessment. This emphasizes the need for improved metrics to better measure patient response to neuromodulation therapies. Additionally, patient-reported percentage improvement in pain was found to be higher than calculated percentage improvement in pain, potentially highlighting the multidimensional experience of pain and the unpredictability of solely using Numeric Rating Scale scores to assess patient outcomes.


2011 ◽  
Vol 14 (5) ◽  
pp. 598-604 ◽  
Author(s):  
Scott L. Parker ◽  
Owoicho Adogwa ◽  
Alexandra R. Paul ◽  
William N. Anderson ◽  
Oran Aaronson ◽  
...  

Object Outcome studies for spine surgery rely on patient-reported outcomes (PROs) to assess treatment effects. Commonly used health-related quality-of-life questionnaires include the following scales: back pain and leg pain visual analog scale (BP-VAS and LP-VAS); the Oswestry Disability Index (ODI); and the EuroQol-5D health survey (EQ-5D). A shortcoming of these questionnaires is that their numerical scores lack a direct meaning or clinical significance. Because of this, the concept of the minimum clinically important difference (MCID) has been put forth as a measure for the critical threshold needed to achieve treatment effectiveness. By this measure, treatment effects reaching the MCID threshold value imply clinical significance and justification for implementation into clinical practice. Methods In 45 consecutive patients undergoing transforaminal lumbar interbody fusion (TLIF) for low-grade degenerative lumbar spondylolisthesis-associated back and leg pain, PRO questionnaires measuring BP-VAS, LPVAS, ODI, and EQ-5D were administered preoperatively and at 2 years postoperatively, and 2-year change scores were calculated. Four established anchor-based MCID calculation methods were used to calculate MCID, as follows: 1) average change; 2) minimum detectable change (MDC); 3) change difference; and 4) receiver operating characteristic curve analysis for two separate anchors (the health transition index [HTI] of the 36-Item Short Form Health Survey [SF-36], and the satisfaction index). Results All patients were available at the 2-year follow-up. The 2-year improvements in BP-VAS, LP-VAS, ODI, and EQ-5D scores were 4.3 ± 2.9, 3.8 ± 3.4, 19.5 ± 11.3, and 0.43 ± 0.44, respectively (mean ± SD). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS, 2.1–5.3; LP-VAS, 2.1–4.7; ODI, 11–22.9; and EQ-5D, 0.15–0.54). The mean area under the curve (AUC) for the receiver operating characteristic curve from the 4 PRO-specific calculations was greater for the HTI versus satisfaction anchor (HTI [AUC 0.73] vs satisfaction [AUC 0.69]), suggesting HTI as a more accurate anchor. Conclusions The TLIF-specific MCID is highly variable based on calculation technique. The MDC approach with the SF-36 HTI anchor appears to be most appropriate for calculating MCID because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was least affected by the choice of anchor. Based on the MDC method with HTI anchor, MCID scores following TLIF are 2.1 points for BP-VAS, 2.8 points for LP-VAS, 14.9 points for ODI, and 0.46 quality-adjusted life years for EQ-5D.


2016 ◽  
Vol 2016 ◽  
pp. 1-10 ◽  
Author(s):  
Hyeong-Jin Lee ◽  
Jin-Sung Kim ◽  
Kyeong-Sik Ryu

Background. Minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) is a widely accepted surgical procedure. But there are only a few reports of MIS-TLIF using the unilateral approach and single cage in elderly patients. Objective. The study investigated the clinical and radiological outcomes of MIS-TLIF using the unilateral approach and single cage in the patients over 65 years of age. Methods. Thirty-eight patients were followed for a mean of 15.5±11.61 months. Radiological data include fusion rate, change of disc height, and central canal area. The numeric rating scale (NRS) and Oswestry disability index (ODI) were used to assess clinical outcomes. Results. The mean age of these patients at operation was 71.82±4.71 years (range, 65–82 years). Evidence of fusion was observed radiologically in 64.71% at 6 months and 87.5% at 12 months after surgery, giving a final fusion rate of 100%. The mean NRS scores for back and leg pain and ODI scores improved significantly at the final follow-up. Conclusions. Clinical and radiologic outcomes of MIS-TLIF using unilateral approach and single cage in elderly patients indicate an acceptable method for the treatment of various kinds of lumbar spinal diseases.


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