Significant Improvement In Oswestry Disability Index Research Articles

Comparative study of percutaneous transfacet screw and pedicle screw in oblique lumbar interbody fusion for the treatment of single-level lumbar spinal stenosis

Objective: To conduct a comparative study of radiological and clinical outcomes between percutaneous transfacet screw (TFS) and pedicle screw (BPS) in oblique lateral lumbar interbody fusion (OLIF) for single-level lumbar spinal stenosis. Methods: A retrospective cohort study. Patients who underwent OLIF with TFS or BPS for the treatment of single-level lumbar spinal stenosis at Beijing Jishuitan Hospital from January 2019 to June 2022 were retrospectively analyzed. Radiological parameters and clinical indicators were compared between the two groups. Radiological parameters included preoperative, immediate postoperative (within 5 days), and 1-year postoperative measurements of disc height and segmental lordosis angle, as well as interbody fusion status at 1 year postoperatively. Clinical indicators included operative time, blood loss, length of hospital stay, complications, and Oswestry Disability Index (ODI), visual analogue scale (VAS) scores for back pain, and leg pain before and 1 year after surgery. Results: Four male and 10 female patients with an average age of (61.0±11.2) years underwent OLIF with TFS, while 9 male and 12 female patients underwent OLIF with BPS, with a mean age of (60.9±6.7) years. There was no statistically significant difference in preoperative disc height between the TFS and BPS groups (P>0.05). The immediate postoperative disc height was (12.9±2.1) mm and it was (10.4±1.7) mm at 1-year follow-up in the TFS group; in the BPS group, it was (12.9±2.1) mm immediately postoperatively and (11.9±2.1) mm at 1-year follow-up; there was statistically significant difference between the two groups at 1-year follow-up (P=0.037). The segmental lordosis angle showed no significant differences within each group or between the two groups at preoperative, immediate postoperative, or 1-year postoperative follow-up (all P>0.05). At 1-year postoperative follow-up, the fusion rates was 92.9%(13/14) in the TFS group and 95.2%(20/21) in the BPS group, with no statistically significant difference between the two groups (P>0.05). The TFS group had a significantly shorter operative time and less blood loss compared to the BPS group [(164.3±33.9) minutes vs (191.7±31.8) minutes and (74.3±46.9) ml vs (124.8±54.0) ml, respectively] (both P<0.05). Both groups showed significant improvement in ODI and VAS scores at 1 year postoperatively compared to those preoperatively, but with no statistically significant difference was found between the groups (both P>0.05). Conclusions: OLIF with TFS fixation can effectively restore disc height and alleviate back and leg pain in patients with single-level lumbar spinal stenosis. Compared to the OLIF with BPS procedure, OLIF with TFS has shorter operative time and less blood loss.

Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion

BackgroundAutologous bone grafts are the gold standard for spinal fusion; however, harvesting autologous bone can result in donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allografts (CBAs) are a viable alternative that avoids the need for bone harvesting and may increase fusion success alone or when used as an adjunct material. The present study examined the efficacy and safety of CBA when used as an adjunct graft material to lumbar arthrodesis.MethodsA prospective, single-arm, multicenter clinical trial (NCT 02969616) was conducted in adult subjects (> 18 years of age) undergoing lumbar spinal fusion with CBA graft (CBA used as primary (≥ 50% by volume), with augmentation up to 50%). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcomes were assessed with the Oswestry Disability Index (ODI), and Visual Analog Scales (VAS) score for back and leg pain. Adverse events were assessed through the 24-month follow-up period. The presented data represents an analysis of available subjects (n = 86) who completed 24 months of postoperative follow-up at the time the data was locked for analysis.ResultsPostoperative 24-month fusion success was achieved in 95.3% of subjects (n = 82/86) undergoing lumbar spinal surgery. Clinical outcomes showed statistically significant improvements in ODI (46.3% improvement), VAS-Back pain (75.5% improvement), and VAS-Leg pain (85.5% improvement) (p < 0.01) scores at Month 24. No subject characteristics or surgical factors were associated with pseudoarthrosis. A favorable safety profile with a limited number of adverse events was observed.ConclusionsThe use of CBA as an adjunct graft material showed high rates of successful lumbar arthrodesis and significant improvements in pain and disability scores. CBA provides an alternative to autograft with comparable fusion success rates and clinical benefits.Trial registrationNCT 02969616.

Outcomes of surgical intervention for degenerative lumbar spondylolisthesis: a comparative analysis of different surgical fixation techniques.

Debate regarding effectiveness of surgical modalities contributes to a lack of consensus of decision making for surgical interventions. Furthermore, data regarding cost effectiveness, surgical operative time, resources, patient hospital stay and recovery is limited, particularly in the medium term for degenerative lumbar spondylolisthesis. The objective was to compare clinical outcomes following different fixation interventions treating degenerative lumbar spondylolisthesis. A retrospective cohort study using the British Spine Registry (BSR) of 1,838 patients aged ≥18 years. Five hundred and five patients undergoing posterior lumbar interbody fusion (PLIF) and 1,333 undergoing transforaminal lumbar interbody fusion (TLIF) with 6 months follow-up, were compared. Demographics, Oswestry Disability Index (ODI), Numerical Rating Scale (NRS) [back and leg], quality of life, complications and cost effectiveness were analysed. NRS (back and leg) demonstrated a statistically significant difference favouring TLIF at 6 months (P=0.04) and (P<0.05) respectively. There was no difference in ODI improvement at 6 months between PLIF and TLIF (P=0.620), but there was a statistically significant difference in ODI scores preoperatively between PLIF and TLIF (P<0.001). EQ-5D-5L-Health VAS (P=0.136) and EQ-5D-5L (P=0.655) did not show a statistically significant difference in improvement between PLIF and TLIF. Dural tear was the most common complication and was higher in the PLIF group (5.7%) but not statistically significant. Estimated blood loss was greater for PLIF (P=0.041). Implant cost (P<0.001) was higher for TLIF whereas theatre time was higher for PLIF (P=0.031). Both PLIF and TLIF result in clinically significant improvements in ODI, NRS back pain and NRS leg pain, with superiority of TLIF for improvements in back and leg pain. Surgeons appeared to use ODI preoperatively to decide intervention with comparable improvements for both approaches. Average theatre time and blood loss volume was higher for PLIF. Factors like implant costs and costs of consumables were higher for TLIF. Costs merit further evaluation.

Long-Term Durability of Stand-Alone Lateral Lumbar Interbody Fusion.

The long-term durability of stand-alone lateral lumbar interbody fusion (LLIF) remains unknown. To evaluate whether early patient-reported outcome measures after stand-alone LLIF are sustained on long-term follow-up. One hundred and twenty-six patients who underwent stand-alone LLIF between 2009 and 2017 were included in this study. Patient-reported outcome measures included the Oswestry Disability Index (ODI), EuroQOL-5D (EQ-5D), and visual analog score (VAS) scores. Durable outcomes were defined as scores showing a significant improvement between preoperative and 6-week scores without demonstrating any significant decline at future time points. A repeated measures analysis was conducted using generalized estimating equations (model) to assess the outcome across different postoperative time points, including 6 weeks, 1 year, 2 years, and 5 years. ODI scores showed durable improvement at 5-year follow-up, with scores improving from 46.9 to 38.5 ( P = .001). Improvements in EQ-5D showed similar durability up to 5 years, improving from 0.48 to 0.65 ( P = .03). VAS scores also demonstrated significant improvements postoperatively that were durable at 2-year follow-up, improving from 7.0 to 4.6 ( P < .0001). Patients undergoing stand-alone LLIF were found to have significant improvements in ODI and EQ-5D at 6-week follow-up that remained durable up to 5 years postoperatively. VAS scores were found to be significantly improved at 6 weeks and up to 2 years postoperatively but failed to reach significance at 5 years. These findings demonstrate that patients undergoing stand-alone LLIF show significant improvement in overall disability after surgery that remains durable at long-term follow-up.

Effect of Muscularity and Fatty Infiltration of Paraspinal Muscles on Outcome of Lumbar Interbody Fusion.

Lumbar paraspinal muscles play an important role in maintaining global spinal alignment and are associated with lower back pain; however, only a few studies on the effect of the paraspinal muscles on the surgical outcome exist. Therefore, this study aimed to analyze the association of preoperative muscularity and fatty infiltration (FI) of paraspinal muscles with the outcome of lumbar interbody fusion. Postoperative clinical and radiographic outcomes were analyzed in 206 patients who underwent surgery for a degenerative lumbar disease. The preoperative diagnosis was spinal stenosis or low-grade spondylolisthesis, and the surgery performed was posterior lumbar interbody fusion or minimally invasive transforaminal lumbar interbody fusion. Indications for surgery were a complaint of severe radiating pain that did not improve with conservative treatment and neurological symptoms accompanied by lower extremity motor weakness. Patients with fractures, infections, tumors, or a history of lumbar surgery were excluded from this study. Clinical outcome measures included functional status, measured using the Oswestry disability index (ODI) and visual analog scale (VAS) score for lower back and leg pain. Other radiographic parameters included measures of spinal alignment, including lumbar lordosis, pelvic tilt, sacral slope, pelvic incidence, C7 sagittal vertical axis, and pelvic incidence-lumbar lordosis mismatch. Lumbar muscularity (LM) and FI were measured preoperatively using a lumbar magnetic resonance image (MRI). The high LM group showed more significant improvement in VAS score for lower back pain than the low LM group. In contrast, the VAS score for leg pain demonstrated no statistical significance. The high LM group showed more significant improvement in ODI postoperatively than the medium group. The severe FI group showed more significant improvement in ODI postoperatively, whereas the less severe FI group showed more significant improvement in the sagittal balance postoperatively. Patients with high LM and mild FI ratio observed on preoperative MRI demonstrated more favorable clinical and radiographic outcomes after lumbar interbody fusion. Therefore, preoperative paraspinal muscle condition should be considered when planning lumbar interbody fusion.

Do preoperative clinical and radiographic characteristics impact patient outcomes following one-level minimally invasive transforaminal lumbar interbody fusion based upon presenting symptoms?

BACKGROUND CONTEXTPatients undergoing minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) frequently present with lower extremity neurologic symptoms with or without associated lower back pain. While symptomatic improvement of leg and back pain has been reported, the resolution of back pain when it is a predominant presenting symptom remains underreported following MI-TLIF. PURPOSEThe purpose of this study was to compare clinical outcomes at 1 year of patients undergoing MI-TLIF with lower extremity neurologic symptoms with and without a significant component of back pain. STUDY DESIGNA retrospective review of prospectively collected data from a single surgeon surgical database from 2017 to 2019 was performed. PATIENT SAMPLEFifty one patients undergoing MI-TLIF. OUTCOME MEASURESSelf-reported measures included the Oswestry Disability Index (ODI), Visual analog scale back pain (VAS-back), and VAS leg pain (VAS-leg). METHODSPatients were divided into two groups: Leg Pain Predominant (patients reported greater than 50% leg pain upon presentation) and Back Pain Predominant (patients reported 50% or greater back pain). Multivariate analysis was performed to determine differences between groups based upon any significantly baseline characteristics. RESULTSPreoperative demographic and radiographic outcomes were similar between the two groups. Both groups demonstrated significant improvement in ODI, VAS-Back and VAS-leg at 1-year postoperatively. On multivariate analysis, there were differences in ODI at 1-year, 1-year back pain, and 1-year leg pain between groups with those who initially presented with leg pain having a lower ODI, VAS Back, and VAS leg. Patients who presented with predominantly leg pain were more likely to meet minimal clinically important difference (MCID) criteria for ODI and VAS-back compared to those with predominantly back pain. CONCLUSIONFollowing MI-TLIF, patients with lower extremity neurologic symptoms with and without a significant component of back pain have improvements in back pain, leg pain, and ODI regardless of their primary presenting pain complaint; however, patients who presented with predominantly leg pain were more likely to meet MCID criteria for improvement in their back pain and ODI score.

P35. Clinical outcome of surgical site infection after spinal fusion

<h3>BACKGROUND CONTEXT</h3> Surgical site infections (SSIs) pose a significant burden to both patients and the health care system with recent focus on the identification and modification of applicable risk factors in spine surgery. However, there is a paucity of literature evaluating the clinical outcomes of patients treated for infection after spine surgery. <h3>PURPOSE</h3> To compare the clinical outcomes of patients who developed SSI after thoracolumbar spine surgery to an aseptic control cohort. <h3>STUDY DESIGN/SETTING</h3> Retrospective propensity matched case-control study. <h3>PATIENT SAMPLE</h3> Adult patients who underwent thoracolumbar spinal fusion between March 2014 and January 2020. <h3>OUTCOME MEASURES</h3> Oswestry Disability Index (ODI), Visual Analog Scale (VAS) Back and Leg, Physical Component (PCS) and Mental Component (MCS) of the SF-12. <h3>METHODS</h3> Structured query language query (SQL) was used to identify patients and extract patient-reported outcome measures (PROMs). Demographic data was extracted through chart review. Patients who developed an SSI were matched to a control cohort based on age, sex, body mass index (BMI), diabetes status, smoking status and race through propensity score matching. <h3>RESULTS</h3> A total of 176 patients (132 Control, 44 SSI) with a mean age of 66 years, body-mass index of 34, ASA of 2.76 were included in final analysis. Both groups demonstrated significant improvements in ODI (Control: p<0.001, SSI: p=0.006), VAS Back (Control: p<0.001, SSI: p=0.002), VAS Leg (Control and SSI:p<0.001), and PCS-12 (Control:p<0.009, SSI:p=0.01) after surgery. Despite comparable preoperative and ∆ODI scores, patients who had an SSI had significantly worse postoperative ODI scores (Control:28.5, SSI: 37.5, p=0.024). ∆VAS Leg, ∆VAS Back, ∆PCS-12, and ∆MCS-12 did not differ significantly between groups with no difference in the proportion of individuals meeting MCID for VAS Leg (60.6% vs 57.1%, p=0.899), VAS Back (Control: 63.6%, SSI: 57.1%, p=0.667), PCS-12 (Control: 22.1%, SSI: 26.1%, p=0.868) or MCS-12 (Control: 20.5%, SSI: 30.4%, p=0.427). <h3>CONCLUSIONS</h3> Despite the associated morbidity of infection after spine surgery, the results of this study demonstrate that patients who sustain SSI after lumbar fusion can ultimately expect similar clinical outcomes as those without postoperative complications and can be used by surgeons to help counsel patients. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Stratifying outcome based on the Oswestry Disability Index for operative treatment of adult spinal deformity on patients 60 years of age or older: a multicenter, multi-continental study on Prospective Evaluation of Elderly Deformity Surgery (PEEDS)

BACKGROUND CONTEXTPatients with adult spinal deformity suffer from disease related disability as measured by the Oswestry Disability Index (ODI) for which surgery can result in significant improvements. PURPOSEThe purpose of this study was to show the change in overall and individual components of the ODI in patients aged 60 years or older following multi-level spinal deformity surgery. STUDY DESIGNProspective, multicenter, multi-continental, observational longitudinal cohort study PATIENT SAMPLEPatients ≥60 years undergoing primary spinal fusion surgery of ≥5 levels for coronal, sagittal or combined deformity. OUTCOME MEASURESOswestry Disability Index (ODI) METHODS: Patients completed the ODI pre-operatively for baseline, then at 10 weeks, 12 months and 24 months post-operatively. ODI scores were grouped into deciles, and change was calculated with numerical score and improvement or worsening was further categorized from baseline as substantial (≥20%), marginal (≥10–<20%) or no change (within 10%). RESULTSTwo-hundred nineteen patients met inclusion criteria for the study. The median number of spinal levels fused was 9 [Q1=5.0, Q3=12.0]. Two-year mean (95% CI) ODI improvement was 19.3% (16.7%; 21.9%; p<.001) for all age groups, with mean scores improved from a baseline of 46.3% (44.1%; 48.4%) to 41.1% (38.5%; 43.6%) at 10 weeks (p<.001), 28.1% (25.6%; 30.6%) at 12 months (p<.001), and 27.0% (24.4%; 29.5%) at 24 months (p<.001). At 2 years, 45.5% of patients showed 20% or greater improvement in ODI, 23.7% improved between 10% and 20%, 26.3% reported no change (defined as±10% from baseline), 4.5% of patients reported a worsening between 10% to 20%, and none reported worsening greater than 20%. 59.0% of patients were severely disabled (ODI >40%) pre-operatively, which decreased to 20.2% at 2 years. Significant improvement was observed across all 10 ODI items at 12 and 24 months. The largest improvements were seen in pain, walking, standing, sex life, social life and traveling. CONCLUSIONSIn this prospective, multicenter, multi-continental study of patients 60 years or older undergoing multi-level spinal deformity surgery, almost 70% of patients reported significant improvements in ODI without taking into account surgical indications, techniques or complications. Clear data is presented demonstrating the particular change from baseline for each decile of pre-operative ODI score, for each sub-score, and for each age group.

A novel lumbar total joint replacement may be an improvement over fusion for degenerative lumbar conditions: a comparative analysis of patient-reported outcomes at one year

Background contextEffective alternatives to lumbar fusion for degenerative conditions have remained elusive. Anterior total disc replacement does not address facet pathology or central/recess stenosis, resulting in limited indications. A posterior-based motion-preserving option that allows for neural decompression, facetectomy, and reconstruction of the disc and facets may have a role. PurposeThe purpose was to compare one-year patient-reported outcomes for a novel, all-posterior, lumbar total joint replacement (LTJR – replacing both the disc and facet joints) against transforaminal lumbar interbody fusion (TLIF) for degenerative lumbar conditions warranting fusion (degenerative spondylolisthesis, recurrent disc herniation, severe foraminal stenosis requiring facet removal, and adjacent segment degeneration). Study design/settingA retrospective analysis of prospectively collected data comparing outcomes for LTJR patients to TLIF patients at an academic teaching hospital. Patient sampleAnalysis was conducted on 156 adult TLIF patients who were propensity matched to the 52 LTJR patients for a total sample of 208. Outcome measuresSelf-reported Oswestry Disability Index (ODI) and Numeric Rating Scale (NRS) for back and leg pain were compared preoperatively, 3 months and 1 year after surgery. MethodsThe implant is a motion-preserving lumbar reconstruction that replaces the function of both the disc and facets and is implanted using a bilateral transforaminal approach with complete facetectomies. Adult patients with degenerative lumbar pathology undergoing either LTJR or open TLIF were analyzed. These degenerative conditions included: grade 1 degenerative spondylolisthesis, recurrent disc herniation, adjacent segment disease, disc degeneration with severe foraminal stenosis). Trauma, tumor, grade 2 or higher spondylolisthesis, spinal deformity, and infection cases were excluded. Propensity score matching was performed to ensure parity between the cohorts. Multivariable regression analyses were done to compare the 1-year results as measured by 3 different standards to assess procedure success. ResultsAt 3 months, both the LTJR and TLIF cohorts showed significant and similar improvements in ODI and NRS back and leg pain. At 1 year, the LTJR cohort showed continued improvement in ODI and NRS back pain, while the TLIF group showed a plateau for ODI, back and leg pain. In a series of three multivariable logistic regressions, LTJR was shown to provide 3.3 times greater odds of achieving the minimal clinical symptom state in disability and pain (ODI <20%, NRS back and leg pain <2) and 2.4 and 4.1 times greater odds of achieving substantial clinical benefit (18% reduction in ODI) and minimal clinically important difference (30% reduction in ODI) as compared to TLIF. ConclusionsHere we present a comparative analysis for the first 52 patients undergoing a novel, posterior-based LTJR for the lumbar spine versus TLIF for degenerative pathology. The approach for the LTJR allows for wide neural decompression, facetectomy, and complete discectomy, with the implant working to replace the function of the disc and facets to preserve motion. At 1 year, the LTJR cohort showed significant improvement in ODI and NRS back and leg pain as compared to TLIF. These results suggest that wide neural decompression combined with motion preservation using this novel LTJR may represent a viable alternative to TLIF for treating certain degenerative conditions. A prospective controlled trial is under development to further evaluate the efficacy, safety, and durability of this procedure.

Functional and radiological outcome of modified spinous process osteotomy (MSPO) technique in decompressive surgery for lumbar canal stenosis

Introduction: The Modified Spinous Process Osteotomy (MSPO) surgery is done for degenerative spinal canal stenosis which gives adequate exposure and avoid iatrogenic instability and long segment fusion following conventional laminectomy. The objective of this article is to evaluate clinical and radiological results of the MSPO. Materials and Methods: Total 20 patients (13 male and 7 female) were included and studied prospectively with multilevel degenerative lumbar canal stenosis that were operated for posterior decompression by MSPO and laminectomy after detailed clinical and radiological work up. Regular follow up was done at 6 weeks 3 months and 1 year, clinical assessment for leg pain and back pain done by VAS, functional measurement of disability by Oswestry Disability Index (ODI) done. Dynamic view X-ray of lumbar spine taken and compared to the preoperative X-ray. CT scan was taken at 1 year post op to assess the union of spinous process. Results: All patients were followed up for 3 years. All patients recovered completely from thigh and leg pain and no patients had neurological deterioration. VAS for LBA and leg pain improved significantly along with significant improvement in ODI. The overall results were good to excellent in 93% of the patients, fair in 7% and no poor outcome. All patients were satisfied with the outcome at the last follow-up. The osteotomised spinous process eventually united with the retained laminar bridge in all patients. Conclusion: A less invasive and less techniquelly demanding MSPO technique provides better exposure and visualization, retaining median structures with least disturbance of kinematics of the lumbar spine. This procedure gives advantages for early ambulation and normalisation of patient’s lifestyle and early return to work. Keywords: MSPO, Decompression, Laminectomies, Lumbar canal stenosis.

Bidirectional Expandable Technology for Transforaminal or Posterior Lumbar Interbody Fusion: A Retrospective Analysis of Safety and Performance.

Expandable devices for transforaminal or posterior lumbar interbody fusion (TLIF and PLIF, respectively) may enable greater restoration of disc height, foraminal height, and stability within the interbody space than static spacers. Medial-lateral expansion may also increase stability and resistance to subsidence. This study evaluates the clinical and radiographic outcomes from early experience with a bidirectional expandable device. This was a retrospective analysis of a continuous series of patients across 3 sites who had previously undergone TLIF or PLIF surgery with a bidirectional expandable interbody fusion device (FlareHawk, Integrity Implants, Inc) at 1 or 2 contiguous levels between L2 and S1. Outcomes included the Oswestry Disability Index (ODI), a visual analog scale (VAS) for back pain or leg pain, radiographic fusion by 1 year of follow-up, subsidence, device migration, and adverse events (AE). There were 58 eligible patients with radiographs for 1-year fusion assessments and 45 patients with ODI, VAS back pain, or VAS leg pain data at baseline and a mean follow-up of 4.5 months. The ODI, VAS back pain, and VAS leg pain scores improved significantly from baseline to final follow-up, with mean improvements of 14.6 ± 19.1, 3.4 ± 2.6, and 3.9 ± 3.4 points (P < .001 for each), respectively. In addition, 58% of patients achieved clinically significant improvements in ODI, 76% in VAS back pain, and 71% in VAS leg pain. By 1 year, 96.6% of patients and 97.4% of levels were considered fused. There were zero cases of device subsidence and 1 case of device migration (1.7%). There were zero device-related AEs, 1 intraoperative dural tear, and 3 subsequent surgical interventions. The fusion rate, improvements in patient-reported outcomes, and the AEs observed are consistent with those of other devices. The bidirectional expansion mechanism may provide other important clinical value, but further studies will be required to elucidate the unique advantages. 4.

75. Prospective, randomized study of lumbar facet replacement and lumbar interbody fusion for spondylolisthesis

BACKGROUND CONTEXT The surgical treatment for lumbar spondylolisthesis has remained somewhat controversial. Posterior lumbar arthroplasty with facet replacement is a novel alternative to lumbar decompression and fusion. There are currently no FDA-approved devices for facet replacement. The TOPS System is a robust, pedicle screw-based biomechanical device intended to replace the facets and posterior elements following aggressive decompression. PURPOSE Lumbar facet replacement is a novel motion-preserving procedure that can be used to treat spondylolisthesis with stenosis. There is an ongoing multicenter, prospective, randomized, controlled US Food and Drug Administration (FDA) Investigation Device Exemption (IDE) trial evaluating the clinical and radiographic outcomes of an investigational facet replacement device and lumbar fusion with interbody fusion with pedicle screw fixation. STUDY DESIGN/SETTING Multicenter, prospective, randomized, US FDA Investigation Device Exemption trial. PATIENT SAMPLE The results of five high enrolling investigational sites from the prospective, randomized IDE trial comparing facet replacement (TOPS) and lumbar interbody fusion (TLiF) in the treatment of Grade I degenerative spondylolisthesis and stenosis were combined to evaluate clinical outcomes. OUTCOME MEASURES The primary clinic outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) as well as re-operation rate. Patients were 2:1 randomized to artificial facet replacement vs TLIF using a monolithic PEEK interbody spacer and pedicle screw fixation. A minimum of 12 months follow-up was required for inclusion in this study. METHODS The results of five high enrolling investigational sites from the prospective, randomized IDE trial comparing facet replacement (TOPS) and lumbar interbody fusion (TLiF) in the treatment of Grade I degenerative spondylolisthesis and stenosis were combined to evaluate clinical outcomes. The primary clinic outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) as well as re-operation rate. Patients were 2:1 randomized to artificial facet replacement vs TLIF using a monolithic PEEK interbody spacer and pedicle screw fixation. A minimum of 12 months follow-up was required for inclusion in this study. RESULTS A total of 129 patients have been enrolled and randomly assigned to either TOPS (n=90) or to TLIF (n= 39). A total of 63 patients were available for follow-up of at least 12 months (TOPS=47, TLIF=16). The reoperation rate for revision, removal or supplemental fixation (RRSF) for facet replacement and TLIF control was 6.7% and 12.8%, respectively. There was no significant difference between groups in baseline mean ODI (TOPS=57; TLIF=56) or VAS Back (TOPS=68; TLIF=68) and Leg scores (TOPS=83; TLIF=84). Both groups showed significant improvement in ODI (TOPS=13; TLIF=14) and VAS Back (TOPS=12; TLIF=14) and VAS Leg (TOPS=12; TLIF=10) from baseline to 12-month follow-up. At 12-month follow-up, 89% of TOPS patients and 81% of TLIF patients showed both a minimum of 15-point ODI improvement and no RRSF reoperation. CONCLUSIONS The preliminary results of this prospective, randomized study are encouraging for both TOPS and TLIF. Both lumbar facet replacement and interbody fusion groups have shown good clinical outcomes with relatively low re-operation rates. There was a trend toward lower reoperation rates with lumbar arthroplasty that did not reach clinical significance. There was no statistically significant difference between the groups in clinic outcome measures. There was a statistically significant level of improvement from baseline and last follow-up in ODI and VAS (Back and Leg) in both treatment groups. Lumbar facet replacement and lumbar interbody fusion both appear to be viable options for treatment of one-level lumbar stenosis due to degenerative spondylolisthesis. Continued enrollment with long-term follow-up is required to validate these early findings as well as to evaluate for any differences between rigid and dynamic stabilization on adjacent level disease. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Analysis of Lumbar Sagittal Curvature in Spinal Decompression and Fusion for Lumbar Spinal Stenosis Patients under Roussouly Classification.

To evaluate the clinical significance of spinal decompression and fusion for lumbar spinal stenosis in old patients under Roussouly classification, 160 old patients (>60 year old) with lumbar spinal stenosis underwent spinal decompression, and fusion were retrospectively studied. According to Roussouly classification, patients were divided into 4 groups, in which Roussouly types I, II, and IV were the nonstandard group and Roussouly type III was the standard group. Visual analog scale (waist, leg) and Oswestry disability index (ODI) scores were recorded before operation and at the final follow-up. All patients improved the sagittal curvature: for patients in Roussouly types I and II, there were statistically significant differences in terms of postoperative global lordosis (GL), global kyphosis (GK), sacral slope (SS), sagittal vertical axis (SVA), and pelvic tilt (PT) compared with that before surgery (all P < 0.001); patients in Roussouly type IV obtained similar results with type III after surgery. The four groups showed significant improvement in ODI and VAS scores at final follow-up (all P < 0.001). After regrouping at the final follow-up, the proportion of the standard type (Roussouly type III) patients was increased compared with preoperative. In conclusion, Roussouly classification has important guiding significance in spinal decompression and fusion for old patients (>60 years) with lumbar spinal stenosis.

Selective local anesthesia versus corticosteroid infiltration on low back pain: a randomized clinical trial

Abstract Antecedents and Objectives Local infiltrations are second line therapy in the treatment of chronic low back pain, although their use is controversial in the literature. Our objective was to compare the effectiveness of 2 types of infiltration at the paravertebral lumbar level in two groups of patients diagnosed with low back pain: corticosteroids, and selective local anaesthetic administered using segmental neural therapy (SNT). Material and Methods Double-blind clinical trial in 55 patients diagnosed with low back pain in the neurosurgery department of the Hospital Central de la Defensa Gomez Ulla. Patients were randomised to 2 treatment groups to receive either paravertebral injections of corticosteroids or SNT. Outcomes were measured using a visual analogue scale (VAS), the Oswestry Disability Index (ODI), the Short Form-36, and patient satisfaction at the start of treatment (baseline) and at 3 and 12 months post intervention. Results The combined treatment group showed a statistically significant improvement in ODI at 3 months. The SNT group showed a statistically significant improvement in baseline VAS vs. VAS at 3 (1.398 cm, p = 0.001) and 12 months (0.791 cm, p = 0.007). No differences were observed in the remaining variables measured. The percentage of patients that would repeat the treatment was 81% and 83%, respectively. Conclusions Significant pain relief was achieved with SNT, and disability improved with the combined treatment. Although clinical improvement was limited, patients were satisfied. Local infiltrations should be considered as an alternative treatment for chronic low back pain. Clinical Trial Registration This clinical trial was registered at the European Union Clinical Trials Register with EUDRA-CT number 2015-001146-29.

Interplay of Dynamic Extension Reserve and T1 Slope in Determining the Loss of Cervical Lordosis Following Laminoplasty: A Novel Classification System

Laminoplasty causes destruction of the posterior musculoligamentous complex, which may result in cervical kyphosis, or more commonly loss of cervical lordosis (LOCL). In this study, we evaluated the role of various preoperative radiologic parameters in predicting not only the LOCL/kyphosis but also the functional outcomes in the form of change in Oswestry Disability Index (ODI) score following laminoplasty. Patients were evaluated both clinically and radiologically with dynamic cervical spine radiograph, noncontrast-enhanced computed tomography, and magnetic resonance imaging of the cervical spine preoperatively as well as at 1 year follow-up. One hundred twenty-one patients who underwent laminoplasty for cervical spondylotic myelopathy/ossified posterior longitudinal ligament from 2011 to 2018 at our center were included in final analysis. In multivariate analysis, preoperative Cobb angle (P= 0.001), T1 slope (TIS; P= 0.001), and dynamic extension reserve (P < 0.001) were found to have an independent effect on LOCL. The receiver operating characteristic curve using the regression model significantly predicted LOCL >10° with an area under the curve of 88.3% (P < 0.001). Similarly, preoperative T1S (P= 0.036) and SVA (P < 0.001) were found to be independent predictors of significant improvement in ODI after laminoplasty. The receiver operating characteristic curve using the regression model significantly predicted change in ODI with an area under the curve of 83.7% (P < 0.001). Based on these findings, classification and scoring systems with good accuracy have been proposed for prediction of LOCL and improvement in ODI. We have found that the chances of significant LOCL is determined by an interplay of preoperative Cobb angle, T1S, and dynamic extension reserve.

A Comparison of Minimally Invasive Transforaminal Lumbar Interbody Fusion and Decompression Alone for Degenerative Lumbar Spondylolisthesis

Abstract INTRODUCTION The optimal minimally invasive surgical (MIS) approach for lumbar spondylolisthesis is not clearly elucidated. This study compares patient reported outcomes (PRO) following MIS transforaminal lumbar interbody fusion (MI-TLIF) and MIS decompression for degenerative lumbar spondylolisthesis. METHODS A total of 608 patients from the Quality Outcomes Database (QOD) Lumbar Spondylolisthesis Module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis of whom 143 underwent MIS [72 MI-TLIF (50.3%) and 71 MIS decompressions (49.7%)]. Surgeries were classified as MIS if there was utilization of percutaneous screw fixation and placement of a Wiltse-plane MIS intervertebral body graft (MI-TLIF) or if there was a tubular decompression (MIS decompression). In total, 24-mo follow-up parameters were collected. PROs included the Oswestry Disability Index (ODI), numeric rating scale (NRS) Back Pain, NRS Leg Pain, EuroQoL-5D (EQ-5D) Questionnaire, and North American Spine Society (NASS) Satisfaction Questionnaire. Multivariate models were constructed adjusting for baseline patient and surgical factors. RESULTS The mean age of the MIS cohort was 67.1 ± 11.3 yr (MI-TLIF 62.1 yr vs MIS decompression 72.3 yr) and consisted of 79 (55.2%) women (MI-TLIF 55.6% vs MIS decompression 54.9%). The proportions reaching 24-mo follow-up were similar (MI-TLIF 83.3% and MIS decompression 84.5%; P = .85). MI-TLIF was associated with higher blood loss (108.8 vs 33.0 mL, P &lt; .001), longer operative times (228.2 vs 101.8 min, P &lt; .001) and length of hospitalization (2.9 vs 0.7 d, P &lt; .001). MI-TLIF was associated with a significantly lower reoperation rate (14.1% vs 1.4%, P = .004). Both cohorts demonstrated significant improvements in ODI, NRS back pain, NRS leg pain, and EQ-5D at 24 mo (P &lt; .001). In multivariate analyses, MI-TLIF was associated with superior ODI change (ß = −7.59; 95% CI [−14.96 to −0.23]; P = .04), NRS back pain change (ß = −1.54; 95% CI [−2.78 to −0.30]; P = .02), and NASS satisfaction (OR = 0.32; 95% CI [0.12-0.82]; P = .02). CONCLUSION For symptomatic, single-level degenerative spondylolisthesis, MI-TLIF was associated with a 10-fold lower reoperation rate and superior outcomes for disability, back pain, and patient satisfaction compared to MIS decompression alone.

Fat Infiltration in the Multifidus Muscle as a Predictor of Prognosis After Decompression and Fusion in Patients with Single-Segment Degenerative Lumbar Spinal Stenosis: An Ambispective Cohort Study Based on Propensity Score Matching

To determine whether fat infiltration in the multifidus muscle would predict surgical prognosis in patients with degenerative lumbar spinal stenosis (DLSS). This ambispective cohort study enrolled 118 consecutive patients undergoing surgery for L4-5 single-segment DLSS. Fat infiltration rate (FIR) on magnetic resonance images of the multifidus muscle at L5-S1 were measured using ImageJ software. The enrolled patients were divided into FIR <25% and FIR ≥25% groups according to their FIR of the multifidus muscle at L5-S1. The 2 groups of patients who finished follow-up were further matched for the baseline covariates based on propensity scores. Patients' reported outcomes including the visual analog scale score for back pain and leg pain, and the Oswestry Disability Index (ODI) score were compared between groups at follow-up and further adjusted using generalized linear models. Patients in the FIR <25% group showed statistically significantly greater reduction in ODI at 6 and 18 months after surgery than did patients in the FIR ≥25% group in either cohort regardless of adjustment; however, the 2-point between-group difference was smaller than the predefined minimum clinically important difference. In addition, more patients in the FIR <25% group achieved clinically significant improvement in ODI than those in the FIR ≥25% group in either complete cohort or matching cohort (63.8% vs. 21.1%, P < 0.001; 70.3% vs. 24.1%, P<0.001, respectively) before and after adjustment (63.3%vs. 27.8%, P < 0.001; 69.1% vs. 31.0%, P < 0.001, respectively). Fat infiltration in multifidus muscle at L5-S1 could be a potential predictor of functional improvement after surgery in patients with L4-5 single-segment DLSS.

PROMIS Physical Function Score Strongly Correlates With Legacy Outcome Measures in Minimally Invasive Lumbar Microdiscectomy.

Retrospective cohort. This study aims to determine the validity of the patient-reported outcomes measurement information system (PROMIS) physical function (PF) in minimally invasive lumbar discectomy (MIS LD) patients. PROMIS was designed to allow for assessment of clinical outcomes in fewer questions than previous outcome measures with the goal of reducing noncompliance associated with longer, time-consuming surveys. However, there exists a paucity of evidence regarding the efficacy of the PROMIS PF domain in patients undergoing MIS LD. A surgical database of patients undergoing 1-3 level MIS LD was retrospectively reviewed. Postoperative changes in PROMIS PF scores were analyzed at 6-weeks, 12-weeks, and 6-months using paired Student t tests. PROMIS scores were compared to Oswestry disability index (ODI), visual analog scale (VAS) back, and VAS leg scores. Correlations were tested using Pearson correlation coefficient. Forty-one MIS LD patients were identified, reporting an average preoperative PROMIS PF score of 35.36 ± 7. Patients demonstrated significant improvement in ODI, VAS back, and VAS leg scores. Additionally, strong associations with PROMIS scores were observed for preoperative and postoperative ODI (r range: 0.5735-0.8543) and postoperative VAS back (r range: 0.5332-0.6522) and VAS leg pain (r range: 0.5257-0.6412). Patients undergoing MIS LD demonstrated significant improvements in PROMIS PF, ODI, VAS back, and VAS leg pain postoperatively. Additionally, improvements in PROMIS physical function scores at each postoperative time point were determined to be significantly correlated with ODI, VAS back, and VAS leg pain. The results of the current study demonstrate PROMIS PF has strong utility as a postoperative outcome assessment tool. 4.

Effects of Physical Therapy on Pain, Functional Status, Sagittal Spinal Alignment, and Spinal Mobility in Chronic Non-specific Low Back Pain.

To investigate the effects of physical therapy (PT) on pain, functional status, sagittal spinal alignment, and spinal mobility in chronic non-specific low back pain (NSLBP). The study population consisted of 100 patients with chronic NSLBP. The study group comprised 60 patients to whom a PT program including superficial heat, transcutaneous electrical nerve stimulation, and ultrasound for 10 sessions was assigned. The control group was composed of 40 patients who received no PT. Home exercise programs were applied to both groups. Pain severity was determined using a Visual Analog Scale (VAS), and functional status was evaluated using the Oswestry Disability Index (ODI). Spinal sagittal alignment in regard to lumbosacral, lumbar lordosis, and thoracic kyphosis angles and spinal mobility regarding lumbar and thoracic flexion and extension degrees were assessed using a digital inclinometer. Lumbar flexion was also assessed using the modified lumbar Schober test (mLST). Evaluations were performed at baseline and after completing the therapy sessions. There were significant decreases in VAS scores in each group upon therapy completion. However, significant improvements in ODI, mLST, and all inclinometric evaluations in terms of sagittal spinal alignment and spinal mobility were noted only in the study group compared with baseline values (p<0.05). Despite the short course of treatment, PT was found to have significant positive effects on pain severity, functional status, sagittal spinal alignment, and spinal mobility. PT was determined to be an effective treatment option for chronic NSLBP.

A prospective randomized study to analyze the efficacy of balanced pre-emptive analgesia in spine surgery

Background ContextSurgical procedures involving the spine are known to cause moderate to severe postoperative pain. Inadequate management of acute pain in the postoperative period results in higher morbidity, and consequently may lead to chronic pain caused by central sensitization. The role of pre-emptive analgesia (PA) and intraoperative analgesia in management of postoperative pain has gained precedence over recent years. Pathophysiology of postoperative pain in spine surgery is unique, as it is a combination of nociceptive, inflammatory, and neuronal stimuli. Blockage of all three stimuli in the perioperative period by pre-emptively administrating a combination of paracetamol (P), ketorolac (K), and pregabalin (PR) might help in adequate management and alleviation of acute postoperative pain. PurposeTo evaluate the analgesic effect of a combination of P, K, and PR as pre-emptive multimodal analgesia, aimed to block or reduce acute postoperative pain after spine surgery. Study DesignA prospective, randomized, controlled, and double-blinded clinical trial. Patient SampleAfter Institutional Review Board approval, 100 consecutive patients requiring single- or double level spinal fusion procedures were randomized into two groups—PA and control (C). MethodsThe PA group received P, K, and PR 4 hours before surgery, as PA. Both groups underwent identical anesthetic and postoperative pain management protocol. Outcome MeasuresDemographic and surgical data, 4 hourly postoperative pain levels—Numeric Pain Rating scale (NRS), Ambulatory NRS scores; level of consciousness—Ramsay sedation scale, total amount of opioids consumed (TOC) through patient-controlled analgesia; functional levels—Oswestry Disability Index (ODI), surgical satisfaction index-North American Spine Society (NASS) satisfaction scale, duration of hospital stay, and all complications were recorded and analyzed. A research grant of 6,032 USD was obtained from AO Spine toward this work. There is no conflict to disclose. ResultsBoth the groups had identical demographic backgrounds and surgical profiles. The average NRS score within the first 48-hour period in the PA group (2.7±0.79) was significantly less than the C group (3.4±0.98) and the differences were more in the first 12 hours following surgery. Similarly, Ambulatory NRS scores were significantly low in the PA group during the first and second postoperative days. The PA group individuals were found to be more physically motivated, as 95.7% were able to ambulate 50 m on the first postoperative day compared with 30% in the C group. The PA group had significantly low TOC (3.02±2.29 mg) in comparison to the C group (4.94±3.08 mg). The duration of hospital stay was 4.17±1.02 and 4.84±1.62 days in the PA and C groups (p=.017), respectively. No major complications occurred in either groups and were found to be similar in percentage between both the groups, except for nausea and vomiting which were more in C group. Dry mouth was the most common side effect noted irrespective of the groups. All patients had significant improvement in ODI with better results in PA group at first month follow up. The PA group (97.90%) was extremely satisfied compared with C group (72%, p=.002) according to NASS scale. ConclusionsPostoperative pain management in spine surgery is maximized if perioperative painful stimuli can be inhibited, which requires adequate blood levels of analgesic, anti-inflammatory, and neuropathic drugs intraoperatively. The employed strategy of preoperative administration of balanced analgesia with a combination of P, K, and PR, each having different mechanisms of action, resulted in lesser pain intensity, allowed better ambulation tolerance, improved functional outcomes and has also reduced the requirement of opioids and duration of hospital stay with no additional complications. Thus, this balanced analgesia administered preoperatively would address the complicated postsurgical pain.