Symptomatic Degenerative Disc Disease Research Articles

217. Impact of previous lumbar spine surgery on outcome of lumbar total disc replacement: analysis of prospective five-year follow up study data

BACKGROUND CONTEXT FDA-regulated prospective trials evaluating lumbar total disc replacement (LTDR) have included patients with previous lumbar surgeries. Unitedhealth care, one of the largest insurers in the United States recently issued a positive coverage policy for LTDR that disqualifies patients with previous lumbar surgeries of any kind from treatment with LTDR. However, such patients were included in FDA IDE trials that led to approval of these devices. PURPOSE The purpose of this study was to compare LTDR outcomes in patients with prior lumbar spine surgery to outcomes in those without prior surgery. STUDY DESIGN/SETTING The study was a post hoc analysis of data collected prospectively as part of an FDA-regulated trial with 5-year follow-up. PATIENT SAMPLE The study was based on 376 patients from the activL® IDE study population. All patients were treated for single-level symptomatic degenerative disc disease at L4-L5 or L5-S1 unresponsive to at least 6 months of nonoperative care. OUTCOME MEASURES Clinical outcome measures used in the study included Oswestry Disability Index (ODI), Visual analog scales (VAS) assessing back and leg pain, SF-36, adverse events and reoperations. Radiographic outcome evaluations were based on flexion/extension range of motion (ROM) and translation of the operated segment. METHODS Patients were divided into two groups: prior lumbar surgery (PLS, n=92) and no prior lumbar surgery (NPLS, n=284). PLS patients had undergone one or more of the following procedures: intradiscal electrothermal annuloplasty (IDET) (n=5), percutaneous nucleoplasty (n=4), microdiscectomy (n=81), hemilaminectomy (n=17), laminotomy (n=36) or other (n=1) prior to receiving a LTDR. Patients with prior lumbar fusion were excluded from the IDE study. Baseline characteristics, functional and pain outcomes, serious adverse events and reoperations were statistically compared between the groups preoperatively and postoperatively at 6 weeks, 3 and 6 months and 1, 2, 3, 4 and 5 years. RESULTS Patient baseline demographics were very similar between the two groups. When comparing pre- to postoperative scores, ODI, VAS back pain and leg pain and the SF-36 Physical Component Score improved significantly (p CONCLUSIONS Prior lumbar spine surgery was not related to compromised outcomes among patients undergoing LTDR. There were no statistically significant differences in ODI, SF-36, pain scores or safety rates between PLS and NPLS patients. These results are in line with findings from earlier studies that prior surgery is not a contraindication for LTDR provided that other selection criteria are met. These results do not support the denial by an insurer to give patients and providers the option of receiving LTDR for DDD unresponsive to nonoperative care as described in the FDA approved device usage labeling. FDA DEVICE/DRUG STATUS activL (Approved for this indication), ProDisc-L (Approved for this indication), Charite (Approved for this indication)

The Impact of Preventative Multimodal Analgesia on Postoperative Opioid Requirement and Pain Control in Patients Undergoing Lumbar Fusions

Abstract INTRODUCTION Preventive multimodal analgesia (PMA) addresses multiple sources and pathways of acute and chronic pain by interfering with peripheral and central sensitization and should provide a way to achieve safer and more effective pain management with reduced opioid medication use. The main objectives of this study were to determine the impact of PMA on postoperative opioid requirements and analgesic effectiveness in patients undergoing lumbar fusion surgery. METHODS A prospective observational study with a historical reference group was performed. The study compared the postoperative opioid requirement and analgesic effect in a total of 103 patients undergoing elective, one- or two-level transforaminal lumbar interbody fusion (TLIF) surgeries for symptomatic lumbar degenerative disc diseases. The PMA patient group included 52 consecutive patients who received 1000 mg of acetaminophen, 300 consecutive patients receiving 900 mg of gabapentin, and 200 consecutive patients receiving 400 mg of celecoxib 1 h before the procedure. The reference group included 51 patients who received 15 mg of morphine-equivalent dose (MED) preoperatively. Multiple linear regression was used to evaluate the influence of PMA on pain, MED, and acetaminophen use over 4 postoperative days (PODs), while controlling for all variables likely to influence these outcomes, including age, gender, baseline opioid use, duration of surgery, postoperative intrathecal morphine use, and administration of muscle relaxants and anticonvulsants. RESULTS The differences in opioid requirement and postoperative pain scores were statistically significant on all 4 postoperative days. The effect size varied from –0.54 to –0.99 for the postoperative opioid requirement and from –0.59 to –1.16 for postoperative pain, indicating that these measures were reduced by about ½ to 1 standard deviation in the PMA patient group. CONCLUSION PMA is a highly effective method for postoperative pain management in patients undergoing lumbar fusion surgeries, which not only improves pain control, but also reduces the opioid requirement.

Risk factors of instrumentation failure and pseudarthrosis after stand-alone L5-S1 anterior lumbar interbody fusion: a retrospective cohort study.

L5-S1 stand-alone anterior lumbar interbody fusion (ALIF) is a reliable technique to treat symptomatic degenerative disc disease but remains controversial for treatment of isthmic spondylolisthesis. In the present study the authors aimed to identify risk factors of instrumentation failure and pseudarthrosis after stand-alone L5-S1 ALIF and to evaluate whether instrumentation failure influenced the rate of fusion. The study included 64 patients (22 [34.4%] male and 42 [65.6%] female, mean age 46.4 years [range 21-65 years]) undergoing stand-alone L5-S1 ALIF using radiolucent anterior cages with Vertebridge plating fixation in each vertebral endplate. Clinical and radiographic data were reviewed, including age, sex, pelvic parameters, segmental sagittal angle (SSA), C7/sacro-femoral distance (SFD) ratio, C7 sagittal tilt, lumbar lordosis (LL), segmental LL, percentage of L5 slippage, L5-S1 disc angle, and posterior disc height ratio. Univariate and multivariate analyses were used to identify risk factors of instrumentation failure and pseudarthrosis. At a mean follow-up of 15.9 months (range 6.6-27.4 months), fusion had occurred in 57 patients (89.1%). Instrumentation failure was found in 12 patients (18.8%) and pseudarthrosis in 7 patients (10.9%). The following parameters influenced the occurrence of instrumentation failure: presence of isthmic spondylolisthesis (p < 0.001), spondylolisthesis grade (p < 0.001), use of an iliac crest bone autograft (p = 0.04), cage height (p = 0.03), pelvic incidence (PI) (p < 0.001), sacral slope (SS) (p < 0.001), SSA (p = 0.003), and LL (p < 0.001). Instrumentation failure was statistically linked to the occurrence of L5-S1 pseudarthrosis (p < 0.001). On multivariate analysis, no risk factors were found. L5-S1 isthmic spondylolisthesis and high PI seem to be risk factors for instrumentation failure in case of stand-alone L5-S1 ALIF, findings that support the necessity of adding percutaneous posterior pedicle screw instrumentation in these cases.

Clinical presentation and outcome after anterior cervical discectomy and fusion for degenerative cervical disc disease.

Background:Anterior cervical discectomy and fusion (ACDF) is a well-described surgical approach for symptomatic degenerative cervical disc disease which does not respond to conservative management. In the present study, we assessed clinical presentation and outcomes of ACDF.Materials and Methods:The present study was conducted from October 1, 2015, to October 31, 2017, in the Department of Neurosurgery, Narayana Medical College and Hospital, Nellore, Andhra Pradesh, among 100 consecutive adult patients who underwent single- or two-level ACDF for degenerative cervical disc disease.Results:The mean age was 47.2 ± 12.8 years (range: 20–74 years). Majority of the patients were male (86/100). Presenting symptoms were neck pain (77%), limb weakness (73%), paresthesias (53%), radicular pain (49%), stiffness in limbs (16%), and bladder involvement (13%). Fusion was done with stand-alone titanium cage/bone graft or titanium cage/bone graft with anterior cervical plate. At the time of discharge, significant improvement in preoperative symptoms (neck pain [47/77-61%], radicular pain [31/49-63%], limb weakness [53/73-72.6%], paresthesias [44/53-83%], stiffness in limbs [13/16-81%], and bladder symptoms [8/13-61%]) was reported by majority of these patients. Majority of these patients also reported improvement in preoperative sensory deficits at the time of discharge. Postoperative complications were hoarseness of voice (22%), dysphagia (16%), deterioration of motor power (8%), and postoperative hematoma (7%).Conclusions:A significant proportion of patients with degenerative cervical disc disease show remarkable recovery after ACDF.

Wednesday, September 26, 2018 7:35 AM–9:00 AM ePosters: P62. Application of laparoscopic lumbar discectomy and artificial disc replacement: at least two years of follow-up

BACKGROUND CONTEXT Symptomatic degenerative disc disease is the major cause of low back pain with lumbar segmental instability. Artificial disc replacement (ADR) has increased in popularity as an alternative treatment for lumbar disc herniation. However, the traditional approach to spinal surgery carries the risk of catastrophic bleeding from injury to major vessels, as well as iatrogenic injury to the viscera and associated structures. Therefore, laparoscopic lumbar discectomy and ADR may represent a useful alternative. PURPOSE The current study aimed to assess the safety and efficacy of ADR using a laparoscopic technique for lumbar disc herniation. STUDY DESIGN/SETTING This prospective observational study included 22 patients who were diagnosed with symptomatic degenerative disc disease treated via ADR with a laparoscopic technique. PATIENT SAMPLE Twenty-two patients (8 males and 14 females) who were diagnosed with symptomatic degenerative disc disease were included in this study. Seven cases involved the L4/5 level, and 15 cases involved the L5/S1 level. All patients were ineffective after at least 6 months of conservative treatments; all patients were informed of the surgery before the operation and provided consent. OUTCOME MEASURES Three-dimensional computed tomographic angiography (3D-CTA) of the iliac great blood vessels was completed before the surgery. All surgical procedures were performed under a laparoscope. All patients were followed up. METHODS Twenty-two patients (8 males and 14 females) who were diagnosed with symptomatic degenerative disc disease were included in this study. Seven cases involved the L4/5 level, and 15 cases involved the L5/S1 level. All patients were ineffective after at least 6 months of conservative treatments; all patients were informed of the surgery before the operation and provided consent. Three-dimensional computed tomographic angiography (3D-CTA) of the iliac great blood vessels was completed before the surgery. All surgical procedures were performed under a laparoscope. All patients were followed up. RESULTS All surgeries were successfully completed. The average operation time was 120 minutes (range 110–150 minutes), and the average hemorrhage was 145 mL (range 80–360 mL). All cases underwent X-ray imaging at 3days, 3 months, 6 months, 1 year, and the final postoperative follow-up. The outcome indicated that there was no mobilization, displacement, or subsidence in all patients with the exception of one case with prosthesis migration. The follow-up time was 43.8 months (range 24–64 months). The mean visual analog scale (VAS) and Oswestry scores were decreased postoperatively. The mean improvement rate of the VAS score was 73.5%. CONCLUSIONS Lumbar ADR using a laparoscope represents a novel, minimally invasive treatment for symptomatic degenerative disc disease and severe lumbar discogenic pain.

Wednesday, September 26, 2018 7:35 AM–9:00 AM ePosters: P134. Application of laparoscopic lumbar discectomy and anterior lumbar interbody fusion: at least six years of follow-up

BACKGROUND CONTEXT Symptomatic degenerative disc disease is the major cause of low back pain with lumbar segmental instability. Anterior discectomy and interbody fusion has increased in popularity as an alternative treatment for lumbar disc herniation. However, the traditional approach to spinal surgery carries the risk of catastrophic bleeding from injury to major vessels, as well as iatrogenic injury to the viscera and associated structures. Therefore, laparoscopic lumbar discectomy and interbody fusion may represent a useful alternative. PURPOSE The current study aimed to assess the mid-term safety and efficacy of lumbar discectomy and anterior lumbar interbody fusion (ALIF) using a laparoscopic technique for lumbar disc herniation. STUDY DESIGN/SETTING This prospective observational study included 32 patients who were diagnosed with symptomatic degenerative disc disease treated via lumbar discectomy and ALIF with a laparoscopic technique. PATIENT SAMPLE Thirty-two patients (12 males and 20 females) who were diagnosed with symptomatic degenerative disc disease were included in this study. Four cases involved the L4/5 level, and 28 cases involved the L5/S1 level. All patients were ineffective after at least 6 months of conservative treatments; all patients were informed of the surgery before the operation and provided consent. OUTCOME MEASURES All patients were followed up for more than 6years, X-ray and CT were reviewed regularly to evaluate the height change of intervertebral space and the fusion of bone graft. The clinical effects of preoperative, postoperative and follow-up were evaluated by VAS score, and the complications of laparoscopic surgery were observed. METHODS Thirty-two patients (12 males and 20 females) who were diagnosed with symptomatic degenerative disc disease were included in this study. Four cases involved the L4/5 level, and 28 cases involved the L5/S1 level. All patients were ineffective after at least 6 months of conservative treatments; all patients were informed of the surgery before the operation and provided consent. Three-dimensional computed tomographic angiography (3D-CTA) of the iliac great blood vessels was completed before the surgery. All surgical procedures were performed under a laparoscope. All patients were followed up for more than 6years, X-ray and CT were reviewed regularly to evaluate the height change of intervertebral space and the fusion of bone graft. The clinical effects of preoperative, postoperative and follow-up were evaluated by VAS score, and the complications of laparoscopic surgery were observed. RESULTS All surgeries were successfully completed. All cases were followed up for more than 6years, the average follow-up time was 9years (range 6–12 years). All cases got bone fusion, the average time was 4.5 months (range 3–12 months). The mean VAS were decreased postoperatively, The VAS score of low back pain for preoperative, postoperative (1 week) and final follow-up was 5.8±1.1, 1.8±0.7, 0.9±0.7, the change were statistically significant (p .05). The outcome indicated that there was no mobilization, displacement or intestinal adhesion in all patients in the mid-term follow-up. CONCLUSIONS Laparoscopic lumbar discectomy and ALIF is an effective treatment for severe degenerative lumbosacral diseases

Total disc replacement versus anterior cervical discectomy and fusion: a systematic review with meta-analysis of data from a total of 3160 patients across 14 randomized controlled trials with both short- and medium- to long-term outcomes.

The aim of this study was to determine how the short- and medium- to long-term outcome measures after total disc replacement (TDR) compare with those of anterior cervical discectomy and fusion (ACDF), using a systematic review and meta-analysis. Databases including Medline, Embase, and Scopus were searched. Inclusion criteria involved prospective randomized control trials (RCTs) reporting the surgical treatment of patients with symptomatic degenerative cervical disc disease. Two independent investigators extracted the data. The strength of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria. The primary outcome measures were overall and neurological success, and these were included in the meta-analysis. Standardized patient-reported outcomes, including the incidence of further surgery and adjacent segment disease, were summarized and discussed. A total of 22 papers published from 14 RCTs were included, representing 3160 patients with follow-up of up to ten years. Meta-analysis indicated that TDR is superior to ACDF at two years and between four and seven years. In the short-term, patients who underwent TDR had better patient-reported outcomes than those who underwent ACDF, but at two years this was typically not significant. Results between four and seven years showed significant differences in Neck Disability Index (NDI), 36-Item Short-Form Health Survey (SF-36) physical component scores, dysphagia, and satisfaction, all favouring TDR. Most trials found significantly less adjacent segment disease after TDR at both two years (short-term) and between four and seven years (medium- to long-term). TDR is as effective as ACDF and superior for some outcomes. Disc replacement reduces the risk of adjacent segment disease. Continued uncertainty remains about degeneration of the prosthesis. Long-term surveillance of patients who undergo TDR may allow its routine use. Cite this article: Bone Joint J 2018;100-B:991-1001.

A comparison of zero-profile anchored spacer (ROI-C) and plate fixation in 2-level noncontiguous anterior cervical discectomy and fusion- a retrospective study

BackgroundAnterior cervical discectomy and fusion (ACDF) is the classic surgical treatment for symptomatic cervical degenerative disc disease (CDDD). However, there is controversy over the best surgical management in patients with two noncontiguous symptomatic levels of CDDD.MethodsFrom April 2011 to May 2014, 44 patients with two noncontiguous symptomatic levels of CDDD underwent skip-level ACDFs. In Group NoPlate, 23 cases underwent 2 noncontiguous levels of ACDF using zero-profile anchored spacer; and in Group Plate, 21 cases underwent 2 noncontiguous levels of ACDF using cages and plates. Operation-related paraeters for each group were recorded and compared. Japanese Orthopedic Association (JOA) scores and Neck Disability Index (NDI) scores at preoperation and postoperation were compared with at least a 2-year follow-up. Cervical lordosis was analyzed before surgery, 1 month after surgery, 3 months after surgery, and at final follow-up.ResultsMean follow-up was 35.4 ± 6.5 (range 24–48) months. Significant improvement on the JOA, NDI scores and cervical lordosis was noted in each group (p < 0.05), and there were no significant difference in terms of JOA, NDI scores, cervical lordosis and fusion rate between the two groups (P > 0.05). The operation time in Group NoPlate was significantly shorter than in Group Plate (p < 0.05), and the incidence of dysphagia and adjacent segment degeneration in Group NoPlate was significantly lower than in Group Plate (p < 0.05).ConclusionsROI-C and cages with plate fixation were both effective in two-level noncontiguous ACDF, and there were no significant difference in clinical outcomes, fusion rate, and cervical lordosis. However, ROI-C was associated with shorter operative time, lower incidence of dysphagia and adjacent segment degeneration.

The Incidence and Association of Mental Depression with Symptomatic Lumbar Degenerative Disc Disease and Treatment Outcome

Study Design: Prospective analytical study. Objectives: The aim was to determine the association between mental depression and symptomatic Lumbar Degenerative Disc Disease (LDDD) in patients with no previous background of mental disorder. We also aimed at determining the incidence of mental depressions in patients with LDDD and the effects of the treatment on the mental depression. Methodology: One hundred and sixty patients with no prior history of mental or behavioral disorders who presented with low back pains arising from LDDD and met inclusion criteria were studied. The clinical findings and Depression Screening Test pro-forma were completed for each. The extracted information was analyzed using Statistical Package for Social Science (SPSS) version 24.0. The statistical significance was set at P < 0.05. Results: One hundred and fifty-three patients completed the study, with a male to female ratio of 1:1.5 and the mean age of the patients was 48.5 years. The marital status was 4.4% single, 86.9% married, 3.8% divorce/separate and 5% widow/widower. Their levels of education were: no formal education (10.00%), primary school level (8.10%), secondary level (27.50%) and Tertiary level (54.40%). Conclusions: This study showed the incidence of mental depression in 32% of the patients with LDDD. We also noted a statistically significant relationship between symptomatic LDDD and level of mental depression with significant improvement in the level of depression at 6th month after treatment. Hence, assessment of the patients’ mental health is important in the management of LDDD.

Transforaminal Lumbar Interbody Fusion With Viable Allograft: 75 Consecutive Cases at 12-Month Follow-up

When conservative treatments fail to alleviate the discomfort of abnormal motion, spinal fusion has been shown to provide symptomatic treatment for spinal instability, stenosis, spondylolisthesis, and symptomatic degenerative disc disease. The trend and rates of fusion over the past few years have been dramatic in the United States. Accompanying that higher incidence has been the shifting from traditional open surgery to minimally invasive techniques to reduce scar tissue formation, extent of muscle stripping, and muscle retraction which all have been shown to adversely affect outcomes. Other reasons supporting the widespread transition to minimally invasive surgical (MIS) techniques include decreased postoperative pain, decreased intraoperative blood loss, shorter postoperative hospital stay, faster return to normal activity, and reduced reoperation rates. Spinal fusion procedures rely on a bony fusion substrate in addition to fixation hardware. While available grafting options include autogenous, allogeneic, and synthetic materials, recent interest in viable allograft material with living cells has drawn attention and attraction for incorporating a biologic basis for regenerative consideration. A recent viable allograft, complete with cellular and designated bone carrier (VIA Graft, Vivex Biomedical, Marietta, Georgia) has been developed. This study represents a retrospective review of a single-practice, single-surgeon evaluation of the product in 75 consecutive patients for fusion by computed tomography (CT) and radiographic evaluation at 12 months in conjunction with a MIS approach. Viable allograft was used to fill the peri-implant space, and central implant lumen was filled with a cancellous bone sponge soaked in perivertebral bone marrow. Posterolateral supplementation was attained with beta-tricalcium phosphate as a bulking agent. A retrospective review identified patients treated for both primary and revision surgery who received VIA Graft cellular bone matrix material in minimally invasive interbody fusion (MIS-TLIF) with a minimum of 12-month follow up. The patient diagnoses included radiculopathy in all instances and varied collateral indications such as foraminal collapse, recurrent disc herniation, and spondylolisthesis to which pain and morbidity had been unresolved by conservative treatment. Adverse events including infection, revisions, and evidence of immune response were evaluated and patient comorbidities defined for the entire population of patients. Patient fusion status was assessed using thin slice CT by 2 independent radiologists separate from the surgeon. There were 75 consecutive adult patients with degenerative conditions of the lumbar spine who underwent MIS-TLIF surgery of which 40 (53%) were male and 35 (47%) were female. Mean age, height, and weight were 58 years, 170.18 cm (67 in), and 88.45 kg (195 lbs), respectively. The mean body mass index was 30. There were 16 patients (21%) who smoked and 12 (16%) with a history of diabetes. Independent blinded review of fusion was obtained by a board certified musculoskeletal radiologist and an experienced board certified orthopaedic surgeon to assess patient fusion status. Spinal segments were deemed fused if 12-month CT scans demonstrated evidence of bridging bone at the fusion site without observed motion on flexion-extension radiographs. Findings such as osteolysis around the implant or pedicle screws, extensive endplate cystic changes, or linear defects parallel to the endplates through intradiscal new bone formation were interpreted as signs of pseudarthrosis. Interobserver and intraobserver error and κ assessments were analyzed to assure agreement in the CT outcomes assessment where interpretation of κ were as follows: <0.00 = poor agreement, 0.00-0.20 = slight agreement, 0.21-0.40 = fair agreement, 0.41-0.60 = moderate agreement, 0.61-0.80 = substantial agreement, and 0.81-1.00 = almost perfect agreement. Differences were resolved by consensus amongst the observers. In total, 96% of the 75 patients with a total of 85 levels (96.5% of levels treated) achieved a fusion at 12 months. There were no perioperative or latent complications and no transfusions in all 75 patients. In this population, 96% of the patients treated achieved the surgical objective in 96.5% of the levels treated. IV. The high rate of fusion, the lack of secondary morbidity with autologous bone harvest, and the clinical success account for the benefits of viable allograft matrix for MIS-TLIF use.

Efficacy and safety of Mobi-C cervical artificial disc versus anterior discectomy and fusion in patients with symptomatic degenerative disc disease: A meta-analysis.

Background:Total disc replacement (TDR) using Mobi-C cervical artificial disc might be promising to treat symptomatic degenerative disc disease. However, the results remained controversial. We conducted a systematic review and meta-analysis to compare the efficacy and safety of Mobi-C cervical artificial disc and anterior cervical discectomy and fusion (ACDF) in patients with symptomatic degenerative disc disease.Methods:PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases were systematically searched. Randomized controlled trials (RCTs) assessing the effect of Mobi-C versus ACDF on the treatment of symptomatic degenerative disc disease were included. Two investigators independently searched articles, extracted data, and assessed the quality of included studies. The primary outcomes were neck disability index (NDI) score, patient satisfaction, and subsequent surgical intervention. Meta-analysis was performed using the random-effect model.Results:Four RCTs were included in the meta-analysis. Overall, compared with ACDF surgery for symptomatic degenerative disc disease, TDR using Mobi-C was associated with a significantly increased NDI score (Std. mean difference = 0.32; 95% CI = 0.10–0.53; P = .004), patient satisfaction (odds risk [OR] = 2.75; 95% confidence interval [CI] = 1.43–5.27; P = .002), and reduced subsequent surgical intervention (OR = 0.20; 95% CI = 0.11–0.37; P < .001). Mobi-C was found to produce comparable neurological deterioration (OR = 0.77; 95% CI = 0.35–1.72; P = .53), radiographic success (OR = 1.18; 95% CI = 0.39–3.59; P = .77), and overall success (OR = 2.13; 95% CI = 0.80–5.70; P = .13) compared with ACDF treatment.Conclusion:Among the 4 included RCTs, 3 articles were studying patients with 1 surgical level, and 1 article reported 2 surgical levels. When compared with ACDF surgery in symptomatic degenerative disc disease, TDR using Mobi-C cervical artificial disc resulted in a significantly improved NDI score, patient satisfaction, and reduced subsequent surgical intervention. There was no significant difference of neurological deterioration, radiographic success, and overall success between TDR using Mobi-C cervical artificial disc versus ACDF surgery. TDR using Mobi-C cervical artificial disc should be recommended for the treatment of symptomatic degenerative disc disease.

Subclinical Propionibacterium acnes infection estimation in the intervertebral disc (SPInE-ID): protocol for a prospective cohort

IntroductionLow back pain and vertebral endplate abnormalities are common conditions within the population. Subclinical infection caused by indolent pathogens can potentially lead to these findings, with differentiation between them notably...

The Role of Hypoxia in Angiogenesis and Extracellular Matrix Regulation of Intervertebral Disc Cells During Inflammatory Reactions.

The intervertebral disc (IVD) is an avascular structure, and is therefore stable under hypoxic conditions. Previous studies have demonstrated that hypoxia might be related to symptomatic degenerative disc diseases (DDDs); however, the pathomechanism is still poorly understood. To identify the effect of hypoxia on the production of inflammatory mediators, angiogenic factors, and extracellular matrix-regulating enzymes of IVD cells during inflammatory reactions. Human nucleus pulposus (NP) and annulus fibrosus (AF) cells harvested during surgery for DDDs were cultured in macrophage conditioned media or interleukin (IL)-1β-stimulated media under hypoxic (2%) and normoxic (21%) conditions. Hypoxia-inducible factor-1α transcription factor activation was analyzed by western blotting. IL-6, IL-8, vascular endothelial growth factor (VEGF), vascular cell adhesion molecule (VCAM), matrix metalloproteinase (MMP)-1, MMP-3, tissue inhibitor of metalloprotease (TIMP)-1, and TIMP-2 in conditioned media were measured by an enzyme-linked immunosorbent assay. NP cells expressed higher hypoxia-inducible factor-1α in the IL-1β-stimulated group under hypoxic condition. MMP-1 was significantly increased in the AF cells under hypoxic condition; TIMP-1 and TIMP-2 were significantly decreased in both naïve NP and AF cells during hypoxia. Both cells in macrophage conditioned media significantly diminished the production of IL-6 and VCAM, while VEGF significantly increased during hypoxia. After 1 ng/mL IL-1β stimulation, IL-8, VEGF, MMP-1, and MMP-3 were significantly increased in both cell types during hypoxia, while VCAM, TIMP-1, and TIMP-2 were decreased. We found that hypoxia can enhance the angiogenic ability of IVD during inflammatory reactions, and cause progress in development of DDD via extracellular matrix regulation in this in vitro study.

Annulo-Nucleoplasty Using Disc-Fx in the Management of Degenerative Lumbar Disc Pathology: How Long Can the Effect Last?

Study Design:Prospective analysis.Objectives:To evaluate 2-year clinical outcomes in patients undergoing Disc-FX for the management of low back pain (LBP) due to degenerate disc (DD) or contained lumbar disc herniation (CLDH). To study salient factors that can potentially influence the clinical outcomes.Methods:We analyzed the prospectively collected data of 51 patients who underwent Disc-FX procedure for DD or CLDH, nonresponsive to 6 months of nonoperative treatment. Clinical outcome measures collected were visual analogue scale (VAS), Oswestry Disability Index (ODI), and MacNab scores. These preoperative values were compared with respective values at immediate, 6 months, 1 year, and 2 years postoperation. Minimum clinically important difference values for these outcomes in accordance with previously published data was used to evaluate the effectiveness of Disc-FX intervention.Results:Of 51 patients, 84% had DD and 16% had CLDH. Significant improvement (P < .01) in VAS and ODI scores was observed at all assessment periods compared to the respective preoperative values. Based on the MacNab scores, there was significant increase (P < .01) in the proportion of patients with excellent/good MacNab outcomes at each time point after the procedure; 78% achieving excellent/good outcomes at 2-year follow-up. Ease of access to the disc space was significantly influencing VAS, ODI, and MacNab scores at 1-year and 2-year follow-ups. VAS and MacNab scores were negatively influenced by high body mass index and smoking status at 6 and 12 months postoperation.Conclusions:Our data suggests that Disc-FX may be helpful in selected patients with symptomatic degenerative disc disease providing favorable outcomes lasting up to 2 years or more. The results were more favorable in patients with easier access to disc space.

Influence of rabbit notochordal cells on symptomatic intervertebral disc degeneration: anti-angiogenic capacity on human endothelial cell proliferation under hypoxia.

Symptomatic degenerative disc disease (DDD) is associated with neovascularization and nerve ingrowth into intervertebral discs (IVDs). Notochordal cells (NCs) are key cells that may lead to regeneration of IVDs. However, their activities under conditions of hypoxia, the real environment of IVD, are not well known. We hypothesized that NCs may inhibit neovascularization by interacting with endothelial cells (ECs) under hypoxia. Human IVDs were isolated and cultured to produce nucleus pulposus (NP) cell conditioned medium (NPCM). Immortalized human microvascular ECs were cultured in NPCM with notochordal cell-rich rabbit nucleus pulposus cells (rNC) under hypoxia. Vascular endothelial growth factor (VEGF), vascular cell adhesion molecule (VCAM), and interleukin-8 (IL-8) were analyzed by ELISA. Focal adhesion kinase (FAK), filamentous actin (F-actin), and platelet-derived growth factor (PDGF) were evaluated to investigate EC activity. Wound-healing migration assays were performed to examine EC migration. The VEGF level of EC cells cultured in NPCM was significantly higher under hypoxia compared to normoxia. VEGF expression was significantly decreased, and FAK, F-actin, PDGF expression were inhibited when ECs were cocultured with rNCs under hypoxia. ECs cocultured with rNC in NPCM showed significantly decreased migratory activity compared to those without rNC under hypoxia. The angiogenic capacity of ECs was significantly inhibited by NCs under hypoxia via a VEGF-related pathway. Our results suggest that NCs may play a key role in the development of IVDs by inhibiting vascular growth within the disc, and this may be a promising novel therapeutic strategy for targeting vascular ingrowth in symptomatic DDD.

Concurrent Use of Lumbar Total Disc Arthroplasty and Anterior Lumbar Interbody Fusion: The Lumbar Hybrid Procedure for the Treatment of Multilevel Symptomatic Degenerative Disc Disease: A Prospective Study.

Study Design.A prospective study.Objective.The aim of this study was to evaluate clinical and patient outcomes post combined total disc arthroplasty (TDA) and anterior lumbar interbody fusion (ALIF), known as hybrid surgery for the treatment of multilevel symptomatic degenerative disc disease (DDD).Summary of Background Data.Class I studies comparing the treatment of one-level lumbar DDD with TDA and ALIF have confirmed the effectiveness of those treatments through clinical and patient outcomes. Although the success of single-level disease is well documented, the evidence relating to the treatment of multilevel DDD with these modalities is emerging. With the evolution of the TDA technology, a combined approach to multilevel disease has developed in the form of the hybrid procedure.Methods.A total of 617 patients underwent hybrid surgery for chronic back pain between July 1998 and February 2012. Visual Analog Pain Scale for the back and leg were recorded along with the Oswestry Disability Index and Roland Morris Disability Questionnaire.Results.Both statistically and clinically significant (p < 0.005) reductions were seen in back and leg pain, which were sustained for at least 8 years postsurgery. In addition, significant improvements (P < 0.001) in self-rated disability and function were also maintained for at least 8 years. Patient satisfaction was rated as good or excellent in >90% of cases.Conclusion.The results of this research indicate that improvements in both back and leg pain and function can be achieved using the hybrid lumbar reconstructive technique.Level of Evidence: 4

Degenerative Cervical Disc Disease: Long-term Changes in Sagittal Alignment and Their Clinical Implications After Cervical Interbody Fusion Cage Subsidence: A Prospective Study With Standalone Lordotic Tantalum Cages.

A retrospective, observational study of prospectively collected outcomes. To investigate the long-term clinical course of anterior cervical discectomy and fusion with interbody fusion cages (ACDF-IFC) with lordotic tantalum implants and to correlate the radiologic findings with the clinical outcomes, with special emphasis on the significance and the influence of implant subsidence. Cage subsidence is the most frequently reported complication after ACDF-IFC. However, most reports fail to correlate cage subsidence with lower fusion rates or with unsatisfactory clinical results. Forty-one consecutive patients with symptomatic degenerative cervical disk disease with failure of conservative treatment were included. All patients underwent 1-/2-level ACDF-IFC with lordotic tantalum implants. The mean follow-up was 4.91 years. The final follow-up fusion rate was 96.96% (32/33). The interspace height (IH) at the affected levels was significantly incremented after implant insertion, and despite a gradual loss in the height over time, the final follow-up IH was significantly higher than that measured preoperatively (P<0.0001). Anterior IH and posterior IH lost 55.8% and 76.2% of the initially incremented height, respectively, with a final increase of 72% in the AIH-PIH height differential. Implant subsidence (>3 mm) occurred in 11 disk spaces (26.82%). Preoperative and postoperative IH were significantly higher in subsidence patients; however, there was no difference in the final follow-up IH (P>0.05). Patients with ≥3 years of follow-up (n=29) did not demonstrate further significant subsidence beyond the second year. Regarding C1-C7 lordosis, the segmental Cobb angle, the cervical Visual Analogue Scale, and Neck Disability Index questionnaires, no difference between patients with or without final follow-up endplate subsidence was encountered. Until fusion occurs, tantalum cage settlement into the vertebral body is to be expected. Further subsidence could be the result of segmental adaptative changes. Graft subsidence did not affect the clinical outcome in any of our patients during long-term follow-up. The occurrence of dynamical implant subsidence had a positive effect on cervical lordosis, especially at the posterior IH.

Early experience with lateral lumbar total disc replacement: Utility, complications and revision strategies

Lumbar total disc replacement (TDR) is an alternative to interbody fusion for the treatment of symptomatic degenerative disc disease. Traditionally, lumbar TDR is performed via an anterior retroperitoneal approach with regional risks of vascular and visceral injury. The direct lateral retroperitoneal, transpsoas approach avoids mobilisation of the great vessels and preserves the anterior longitudinal ligament, thereby maintaining physiological limits on motion. This study aimed to (i) report one site’s early experience with lateral lumbar TDR and (ii) provide case examples illustrating the utility, complications and revision strategies of the XL-TDR device. Data were collected prospectively on the first 12 consecutive patients treated with XL-TDR. Patient outcomes included pain (VAS), disability (ODI), and quality of life (SF-36 PCS and MCS). Mean follow-up was 27.5months (range 18–48months). Patients had significant improvements in back (74%) and leg (50%) pain, ODI (69%), PCS (50%) and MCS (39%) (P<0.05). Two patients had early prosthesis dislocation due to prosthesis undersizing. The same skin incision was used to retrieve the XL-TDR and perform salvage lateral lumber interbody fusion, with solid fusion by 12months. Lumbar TDR using the XL-TDR via a lateral transpsoas muscle-splitting approach is a minimally invasive alternative to anterior retroperitoneal exposures for motion preservation. Correct sizing of the XL-TDR and complete contralateral annulectomy with annulus box cutters mitigates the risk of lateral dislocation. Revision surgery for lateral dislocation of the XL-TDR is more straightforward compared to anterior TDR dislocation.

Application of Laparoscopic Lumbar Discectomy and Artificial Disc Replacement: At Least Two Years of Follow-Up.

This prospective observational study included 22 patients who were diagnosed with symptomatic degenerative disc disease treated via artificial disc replacement (ADR) with a laparoscopic technique. The current study aimed to assess the safety and efficacy of ADR using a laparoscopic technique for lumbar disc herniation. Symptomatic degenerative disc disease is the major cause of low back pain with lumbar segmental instability. ADR has increased in popularity as an alternative treatment for lumbar disc herniation. However, the traditional approach to spinal surgery carries the risk of catastrophic bleeding from injury to major vessels, as well as iatrogenic injury to the viscera and associated structures. Therefore, laparoscopic lumbar discectomy and ADR may represent a useful alternative. Twenty-two patients (8 males and 14 females) who were diagnosed with symptomatic degenerative disc disease were included in this study. Seven cases involved the L4/5 level, and 15 cases involved the L5/S1 level. All patients were ineffective after at least 6 months of conservative treatments; all patients were informed of the surgery before the operation and provided consent. Three-dimensional computed tomographic angiography (3D-CTA) of the iliac great blood vessels was completed before the surgery. All surgical procedures were performed under a laparoscope. All patients were followed up. All surgeries were successfully completed. The average operation time was 120 minutes (range 110-150 min), and the average hemorrhage was 145 mL (range 80-360 mL). All cases underwent X-rays at 3 days, 3 months, 6 months, 1 year, and the final postoperative follow-up. The outcome indicated that there was no mobilization, displacement, or subsidence in all patients with the exception of one case with prosthesis migration. The follow-up time was 43.8 months (range 24-64 months). The mean visual analog scale (VAS) and Oswestry scores were decreased postoperatively. The mean improvement rate of the VAS score was 73.5%. Lumbar ADR using a laparoscope represents a novel, minimally invasive treatment for symptomatic degenerative disc disease and severe lumbar discogenic pain.

98 - Seven-Year Clinical Results of Cervical Total Disc Replacement Compared with Anterior Discectomy and Fusion for Treatment of Two-Level Symptomatic Degenerative Disc Disease: A Prospective, Randomized, Controlled, Multicenter FDA Clinical Trial

98 - Seven-Year Clinical Results of Cervical Total Disc Replacement Compared with Anterior Discectomy and Fusion for Treatment of Two-Level Symptomatic Degenerative Disc Disease: A Prospective, Randomized, Controlled, Multicenter FDA Clinical Trial