Spine Patient Outcomes Research Trial Research Articles

UNEXPLAINED UNILATERAL LOWER LIMB NEUROLOGICAL DEFICITS AFTER POSTERIOR SPINAL DECOMPRESSION AND FUSION FOR DEGENERATIVE LUMBAR SPONDYLOLISTHESIS

The observational data from the Spine Patient Outcomes Research Trial (SPORT) confirm the superiority of surgical over conservative management of symptomatic degenerative spondylolisthesis. The most common reported neurologic complications after lumbar posterior decompression and fusion are implant malposition, contralateral foraminal stenosis, hematoma/seroma, arachnoiditis, and nerve root oedema or vascular underlying causes. The current study reported that the patient developed unexpected left side neurological deficit after conventional lumbar posterior spinal decompression surgery for degenerative spondylolisthesis. No intraoperative dural insult. The computer topography (CT) scan and magnetic resonance imaging (MRI) of the spine after index surgery show adequate canal and foraminal decompression. No hardware-related complications or compressive hematoma could explain the patient’s symptoms. The patient recovered completely after removing the redundant posterolateral bone graft. The theory behind that is aggressive posterolateral dissection over the transverse process and abundant application of the bone graft might compress or injure the lumbar plexus. So, we suggested a delicate dissection posterolaterally and only a reasonable amount of bone graft could be applied to prevent such a devastating neurological complication.

113. Lumbar discectomy patients who undergo reoperation experience worse clinical outcomes and greater socioeconomic burden four years after the primary procedure

BACKGROUND CONTEXT Multiple studies have observed that the clinical outcomes of patients who have undergone revision surgery after lumbar discectomy are less positive than outcomes in patients who did not require revision. Lumbar disc herniation patients with large annular defects undergoing discectomy are at significantly greater risk for symptom recurrence and revision, indicating that this population is also at significantly greater risk for worse clinical outcomes. The goal of this analysis was to assess the clinical and socioeconomic outcomes associated with post-discectomy reoperations and the utility of a bone-anchored annular closure device (ACD) for avoiding reoperations in patients with large annular defects. PURPOSE Not applicable. STUDY DESIGN/SETTING Not applicable. PATIENT SAMPLE Not applicable. OUTCOME MEASURES Not applicable. METHODS This was a retrospective analysis of a prospective randomized controlled trial (RCT). Lumbar discectomy patients with large (≥6 mm) annular defects were randomized to treatment with limited discectomy alone (Control; n=278) or limited discectomy augmented by an annular closure device (ACD; n=272). Clinical outcomes included visual analog scale (VAS) for ipsilateral leg and back pain, Oswestry Disability Index (ODI), reoperations at the index-level, serious adverse events (SAE), and working status. Comparisons of clinical and socioeconomic outcomes were made between reoperated and nonreoperated patients, regardless of ACD or Control treatment, at 4 years following the primary surgery. RESULTS At 4 years, clinical outcomes data were available for 73% of the patients. Among patients with data at 4 years, 64 experienced at least one index-level reoperation (Reoperated group) and 340 were not reoperated (Non-reoperated group). The Kaplan-Meier estimate of subjects experiencing at least one index-level reoperation within 48 months was 14.4% in the ACD group and 21.1% in the Control group (p=0.03 log-rank). In all, 49 procedures were performed in ACD subjects and 77 procedures performed in Control subjects. The reoperated patients had significantly worse scores than non-reoperated patients for ODI (22 ± 16 vs 11 ± 13; p CONCLUSIONS Index-level reoperations following lumbar discectomy in patients with large annular defects are associated with worse clinical outcomes and greater socioeconomic burden. These findings are consistent with reports on outcomes from large registry analyses including the Spine Patient Outcomes Research Trial (SPORT) and the Swedish National Spine Registry (Swespine). The ACD was effective in minimizing the number of patients subject to revision, primarily through prevention of repeat discectomy, with 33% fewer patients undergoing at least one index-level reoperation. FDA DEVICE/DRUG STATUS Barricaid Annular Closure Device (ACD) - (Approved for this indication).

Systematic Review of Outcomes Following 10-Year Mark of Spine Patient Outcomes Research Trial (SPORT) for Degenerative Spondylolisthesis.

We performed a comprehensive search of PubMed, MEDLINE, and EMBASE for all English language studies of all levels of evidence pertaining to Spine Patient Outcomes Research Trial (SPORT), in accordance with Preferred Reported Items for Systematic Reviews and Meta-analyses guidelines. We aim to summarize the 10-year clinical outcomes of SPORT and its numerous follow-up studies for degenerative spondylolisthesis. The SPORT was a landmark randomized control trial including approximately 2500 patients at 13 clinics across the country. SPORT compared surgical and nonoperative management of the three most common spinal pathologies. Keywords used in the literature search included SPORT, spine patient outcomes research trial, degenerative spondylolisthesis, and surgical outcomes. The intent-to-treat analysis failed to show a significant difference between patients treated surgically as compared to those treated nonoperatively. However, as-treated analysis revealed statically greater improvements at 6 weeks, 2 years, and 4 years in patients treated surgically. Secondary outcomes such as low back pain, leg pain, stenosis bothersome scales, overall satisfaction with current symptoms, and self-rated progress were also significantly improved in surgical patients. Regardless of the initial grade of listhesis, disk height, or mobility, patients who had surgical treatment improved more in terms of Oswestry Disability Index, bodily pain, physical function, and low back pain bothersomeness scales. Risk of reoperation increased with age, having two or three moderate or severe stenotic levels, pain predominantly localized to the back, no physical therapy, the absence of neurogenic claudication, and greater leg pain scores. Risk of reoperation was not significantly affected by type of surgery performed, smoking, diabetes, obesity, longer duration of symptoms, or workman's compensation. Although intent-to-treat analysis failed to show significant differences in patients treated surgically, results of the as-treated analysis determined statically greater improvements in those patients with spondylolisthesis who were treated surgically as compared to those treated nonoperatively. 2.

Comparing Patient-reported Outcomes to Patient Satisfaction After a Microdiscectomy for Patient’s With a Lumbar Disk Herniation

A retrospective cohort study. The objective of this study was to determine if patient satisfaction is predicted by improvement in health-related quality of life (HRQOL) metrics. Patient satisfaction is becoming an increasingly common proxy for treatment quality; however, the correlation between patient satisfaction and HRQOL outcome metrics following a lumbar disk herniation is unclear. Patients enrolled in the Spine Patient Outcomes Research Trial (SPORT) study were prospectively enrolled at 13 institutions. A retrospective subgroup analysis of prospectively collected data from the SPORT trial was performed. Receiver operating characteristic curves were used to determine if improvement in HRQOL metrics could accurately identify patient satisfaction. HRQOL metrics included: Short Form-36 (SF-36), Oswestry Disability Index (ODI), Sciatica Bothersomeness Index, Back Pain Bothersomeness Scale, and Leg Pain Bothersomeness Scale. A total of 709 patients who underwent surgery and 319 patients treated without surgery were included. In the surgical cohort, receiver operating characteristic curve analysis demonstrated that SF-36 Physical Component Summary improvement had moderate accuracy [area under the curve (AUC)=0.77 (95% confidence interval, CI: 0.73-0.82)] at predicting satisfaction at 3 months, and it had excellent accuracy at predicting satisfaction at 2 years [AUC=0.81 (95% CI: 0.77-0.85)] and 4 years [AUC=0.81 (95% CI: 0.76-0.85)]. Absolute Physical Component Summary score had excellent accuracy at 3 months [AUC=0.83 (95% CI: 0.79-0.87)], 2 years [AUC=0.87 (95% CI: 0.84-0.9)] and 4 years [AUC=0.84 (95% CI: 0.8-0.89)]. Similarly improvement in the ODI had moderate accuracy of predicting satisfaction at 3 months [AUC=0.77 (95% CI: 0.72-0.81)], 2 years [AUC=0.78 (95% CI: 0.74-0.82)] and 4 years [AUC=0.78 (95% CI: 0.73-0.83)], and the absolute ODI score had excellent accuracy at 3 months [AUC=0.85 (95% CI: 0.82-0.89)], 2 years [AUC=0.89 (95% CI: 0.86-0.92)], and 4 years [AUC=0.88 (95% CI: 0.85-0.92)]. HRQOL metrics can accurately predict patient satisfaction with symptoms at 3 months, 2 years, and 4 years after surgical intervention for a lumbar disk herniation. Absolute outcome scores were somewhat more predictive than change scores.

Systematic Review of Outcomes Following 10-Year Mark of Spine Patient Outcomes Research Trial for Intervertebral Disc Herniation.

We performed a comprehensive search of Pubmed, MEDLINE, and EMBASE for English-language studies of all levels of evidence pertaining to SPORT, in accordance with Preferred Reported Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. We aim to summarize the 10-year clinical outcomes of SPORT and its numerous follow-up studies for intervertebral disc herniation. The Spine Patient Outcomes Research Trial (SPORT) was a landmark study. SPORT compared surgical and nonoperative management of the three most common spinal pathologies. Keywords utilized included: SPORT, spine patient outcomes research trial, disc herniation, and surgical outcomes. The observational cohort analysis revealed statically greater improvement in primary outcomes at 3 months and 2 years in patients who had surgery, while analysis of the randomized control trial cohort failed to show a significant difference based on the intent-to-treat principle due to significant patient crossover. However, 4 year and 8 year as-treated analysis showed statistically greater improvements in those patients who were treated surgically. SPORT's subgroup analysis evaluated important factors when considering the treatment of IDH, including patient characteristics, level of herniation, duration of symptoms, recurrence of pain, presence of retrolistheiss, patient functional status, effects of previous treatment with epidural steroid injections and opioid medication, outcomes after incidental durotomy, MRI reader reliability, reoperation rates, and risk factors for reoperation. The clinical impact of SPORT was also investigated and included comparison of SPORT patients to NSQIP patients to determine generalizability, outcome differences in SPORT's surgical center sites, patient preferences, patient expectations, level of education, and effects of watching an evidence-based video. Ten years after its inception, SPORT has made strides in standardization and optimization of treatment for spinal pathologies. SPORT has provided clinicians with insight about outcomes of surgical and nonoperative treatment of IDH. Results showed significantly greater improvements in patients treated surgically. 3.

Systematic Review of Outcomes Following 10-year Mark of Spine Patient Outcomes Research Trial (SPORT) for Spinal Stenosis.

We performed a comprehensive search of Pubmed, MEDLINE, and EMBASE for all English-language studies of all levels of evidence pertaining to SPORT, in accordance with Preferred Reported Items for Systematic Reviews and Meta-analayses (PRISMA) guidelines. We aim to summarize the 10-year clinical outcomes of SPORT and its numerous follow-up studies for spinal stenosis. The Spine Patient Outcomes Research Trial (SPORT) was a landmark randomized control trial including approximately 2,500 patients at 13 clinics across the country. SPORT compared surgical and nonoperative management of the three most common spinal pathologies. Keywords utilized in the literature search included: SPORT, spine patient outcomes research trial, spinal stenosis, and surgical outcomes. Surgical intervention showed significantly greater improvement in pain and physical function scales from 6 weeks through 4 years. However, between 4 and 8 years, the difference between the two groups diminished, and the benefits in both groups stabilized. Secondary factors investigated showed that smoking was a confounding variable for treatment benefits and a positive sedimentation sign correlated with a greater surgical treatment effect. Obese patients were found to have higher rates of infection and reoperation and less improvement from baseline function. Risk factors for reoperation included duration of pretreatment symptoms for longer than 12 months, increased age, multiple levels of stenosis, predominant back pain, no physical therapy, greater leg pain, the use of antidepressants and no neurogenic claudication upon enrollment. Ten years after its inception, SPORT has made strides in standardization and optimization of treatment for spinal pathologies. SPORT has provided clinicians with insight about outcomes of surgical and nonoperative treatment of spinal stenosis. Results showed significantly greater improvement through 4 year follow up in those patients that received surgical treatment, however the difference between the surgical and nonsurgical groups diminished at 8 year follow up. 3.

P44. Epidural steroid injections show little relationship with improved clinical outcomes in both operative and nonoperative management of degenerative spondylolisthesis

BACKGROUND CONTEXT Although epidural steroid injection (ESI) has been shown to provide adequate pain relief for degenerative spondylolisthesis patients in treatment regimens up to months, it remains unclear whether the use of ESI affects the rate of crossover from nonoperative to operative management. PURPOSE Investigate the relationship between epidural steroid injections and rates of surgical crossover for degenerative spondylolisthesis patients. STUDY DESIGN/SETTING Retrospective review of prospectively collected data from 13 spine centers. PATIENT SAMPLE Degenerative spondylolisthesis patients from both the randomized and concurrent observational cohorts of the Spine Patient Outcomes Research Trial (SPORT). OUTCOME MEASURES Primary: Surgical crossover rates. Secondary: health related quality of life outcome (HRQL) measures (SF-36, ODI, Sciatica and Leg Pain Bothersomeness Indices), self-reported improvement METHODS Included: surgical candidates >18yrs with degenerative spondylolisthesis. Excluded: patients receiving ESI before enrollment. Those who received ESI within 3 months of enrollment (ESI) and those who did not (no-ESI) were compared for differences in baseline characteristics. Outcomes at 1-year, 2-year, 3-year, and 4-year intervals following enrollment were assessed within operative and nonoperative groups using longitudinal mixed–effect models with random subject intercept term to account for correlations between repeated measurements. Treatment comparisons were performed at follow-up intervals. Area under the curve analysis for all time points assessed global significance of treatment. RESULTS Included: 266 patients (192 no-ESI, 74 ESI). Patient groups did not differ in age, sex, BMI, or comorbidity burden (all p>0.05). No-ESI had greater baseline SF-36 body-pain scores (38±20 vs 30±16, p=0.002) and self-reported surgical preference (38% vs 11%, p 0.05). Surgical ESI and no-ESI patients showed no differences in postoperative HRQL changes at any follow-up interval, or in 4-year average HRQL outcomes. Non-operative no-ESI patients showed greater 4-year average improvement in SF-36 body pain (no-ESI: 17.8, ESI: 7.8, p=0.004) and physical function (no-ESI: 13.1, ESI: 4.3, p=0.005) than non-operative ESI patients. These improvements in SF-36 body pain were greater for non-operative no-ESI patients at 1-year (p=0.002) and 3-years (p=0.005); improvements in SF-36 physical function were greater for non-operative no-ESI patients at 1-year (p=0.030) and 2-years (p=0.002). Of patients that were initially non-operative, there was no difference between ESI and no-ESI groups in surgical crossover rates (ESI: 52%, no-ESI: 39%, p=0.15). For operative patients, crossover rates to non-operative treatment did not differ between ESI and no-ESI groups (ESI: 23%, no-ESI: 16%, p=0.38). CONCLUSIONS For surgical degenerative spondylolisthesis patients, there was no relationship between ESI and improved clinical outcomes over a 4-year study. For nonoperative patients, ESI was associated with inferior pain reduction through 3 years of follow-up; however, this was confounded by higher levels of baseline pain. ESI showed little relationship with surgical crossover. FDA DEVICE/DRUG STATUS Unavailable from authors at time of publication.

Reoperations Following Lumbar Discectomy Are Associated With Worse Clinical Outcomes and Greater Socioeconomic Burden 3 Years After the Primary Procedure

Abstract INTRODUCTION Lumbar discectomy patients with large annular defects are at significantly greater risk for symptom recurrence and revision. Previous studies suggest that outcomes following revision surgery are less positive than outcomes from primary discectomy. This analysis aimed to assess the clinical and socioeconomic outcomes associated with postdiscectomy reoperations and the utility of a bone-anchored annular closure device (ACD) for avoiding reoperations. METHODS This study was a retrospective analysis of a prospective randomized controlled trial (RCT). Lumbar discectomy patients with large (>6 mm) annular defects were treated with discectomy alone (Control; n = 278) or discectomy with an ACD (n = 272). Patient-reported outcomes included visual analog scale (VAS) for ipsilateral leg or back pain and Oswestry Disability Index (ODI). At 3 yr, clinical outcomes were available for 75% of the patients. Comparisons of outcomes were made between reoperated (n = 64) and nonreoperated (n = 351) patients, regardless of ACD or Control treatment, at 3 yr following the primary surgery. RESULTS Reoperated patients had significantly worse scores for ODI (24 ± 19 vs 11 ± 13; P < .0001), VAS leg pain (28 ± 30 vs 12 ± 19; P < .0001), and VAS back pain (36 ± 31 vs 17 ± 21; P < .0001). Significantly more nonreoperated patients were working at 3 yr (97% vs 84%; P < .001). Based on Kaplan-Meier analysis, the proportion of subjects experiencing at least 1 index-level reoperation in 3 yr was 11% in the ACD group and 19% in the Control group (P = .007). CONCLUSION Index-level reoperations following lumbar discectomy are associated with worse outcomes and greater socioeconomic burden in patients with large annular defects (>6 mm). These findings are consistent with reports from large registry analyses, including the Spine Patient Outcomes Research Trial (SPORT) and the Swedish National Spine Registry (Swespine). The ACD reduced the number of patients experiencing index-level reoperation by 43%.

Lumbar disc herniation: what has the Spine Patient Outcomes Research Trial taught us?

Intervertebral disc herniation (IDH) can cause back pain and/or radiculopathy and accounts for a significant portion of patients having spinal surgery in the USA. One of the most impactful and well-executed randomized trials to study diagnosis, treatments, and outcomes in patients with three commonly treated spinal conditions was the Spine Patient Outcomes Research Trial (SPORT). This study and the subsequent data analyses have resulted in numerous publications related to IDH. The purpose of this review is to summarize SPORT publications with IDH results to better understand what we have learned from this important landmark trial. Publications utilizing SPORT data that reported findings related to IDH patients were identified from Medline, PubMed, and PubMed Central. The primary findings pertaining to IDH were summarized. There were 25 studies identified reporting findings related to IDH from the SPORT data published between 2004 and 2017. Publications in the following areas were summarized: epidemiology and baseline patient characteristics (1), treatment preferences and expectations (2), radiological and MRI (3), primary study objectives at twoyears (2), fouryears (1) and eightyears (1), subgroup analyses (13), cost-effectiveness (1), and reherniation (1). This report reviewed the current state of SPORT publications related to IDH to identify and summarize what we have learned about diagnosis, patient characteristics, treatments, outcomes, and cost-effectiveness in patients with lumbar disc herniations. Many important findings are now published from this robust trial's data. Clinicians should incorporate these results into their clinical decision-making and during counseling patients presenting with lumbar disc herniations.

Nonsurgical Treatment Choices by Individuals with Lumbar Intervertebral Disc Herniation in the United States: Associations with Long-term Outcomes.

The objectives of this study were to (1) evaluate differences between patients with lumbar intervertebral disc herniation who received physical therapy (PT) and those who did not; (2) identify factors associated with receiving PT; and (3) examine the influence of PT on clinical outcomes over the course of 1 yr. An observational cohort study using data from the Spine Patient Outcomes Research Trial was conducted. This study included 363 patients with intervertebral disc herniation who received nonsurgical management within 6 wks of enrollment. Baseline characteristics were compared between patients who received PT and those who did not. Multivariate logistic regression examined factors predictive of patients receiving PT. Mixed effects models were used to compare primary outcomes (Short-Form Survey 36 bodily pain and physical function and modified Oswestry Index) at 3 and 6 mos and 1 yr after enrollment. Forty percent of the nonsurgical cohort received PT. Higher disability scores, neurological deficit, and patient preference predicted PT use. Compared with other nonsurgical management strategies, standard care PT was not associated with a significant difference in pain, disability, or surgery over 1 yr. Many patients with intervertebral disc herniation seek secondary care for persisting symptoms and pursue nonsurgical management. The best management strategy is unclear and further research is needed to examine appropriate sequencing and selection of treatment.

Reoperation for Recurrent Intervertebral Disc Herniation in the Spine Patient Outcomes Research Trial: Analysis of Rate, Risk Factors, and Outcome.

This study was a post-hoc subgroup analysis of prospectively collected data in the Spine Patient Outcomes Research Trial (SPORT). The aim of this study was to determine the risk factors for and to compare the outcomes of patients undergoing revision disc excision surgery in SPORT. Risk factors for reherniation and outcomes after revision surgery have not been well-studied. This information is critical for proper patient counseling and decision-making. Patients who underwent primary discectomy in the SPORT intervertebral disc herniation cohort were analyzed to determine risk factors for undergoing revision surgery. Risk factors for undergoing revision surgery for reherniation were evaluated using univariate and multivariate analysis. Primary outcome measures consisted of Oswestry Disability Index (ODI), the Sciatica Bothersomeness index (SBI), and the Short Form 36 (SF-36) at 6 weeks, 3 months, 6 months, and yearly to 4 years. Of 810 surgical patients, 74 (9.1%) received revision surgery for reherniation. Risk factors for reherniation included: younger age (hazard ratio [HR] 0.96 [0.94-0.99]), lack of a sensory deficit (HR 0.61 [0.37-0.99]) lack of motor deficit (HR 0.54 [0.32-0.91]), and higher baseline ODI score (HR 1.02 [1.01-1.03]). The time-adjusted mean improvement from baseline to 4 years was less for the reherniation group on all outcome measures (Bodily Pain Index [BP] 39.5 vs. 44.9, P = 0.001; Physical Function Index [PF] 37.1 vs. 44.5, P < 0.001; ODI 33.9 vs. 38.3, P < 0.001; SBI 8.7 vs. 10.5, P < 0.001). At 4 years, only SBI (-9 vs. -11.4, P = 0.002) was significantly lower in the reherniation group. Younger patients with higher baseline disability without neurological deficit are at increased risk of undergoing revision surgery for reherniation. Those considering revision surgery for reherniation will likely improve significantly following surgery, but possibly not as much as with primary discectomy. 3.

Risk Factors for Reoperation in Patients Treated Surgically for Lumbar Stenosis: A Subanalysis of the 8-year Data From the SPORT Trial.

A retrospective subgroup analysis was performed on surgically treated patients from the lumbar spinal stenosis (SpS) arm of the Spine Patient Outcomes Research Trial (SPORT), randomized, and observational cohorts. To identify risk factors for reoperation in patients treated surgically for SpS and compare outcomes between patients who underwent reoperation with those who did not. SpS is one of the most common indications for surgery in the elderly; however, few long-term studies have identified risk factors for reoperation. A post-hoc subgroup analysis was performed on patients from the SpS arm of the SPORT, randomized and observational cohorts. Baseline characteristics were analyzed between reoperation and no-reoperation groups using univariate and multivariate analysis on data 8 years postoperation. Of the 417 study patients, 88% underwent decompression only, 5% noninstrumented fusion, and 6% instrumented fusion. At the 8-year follow-up, the reoperation rate was 18%; 52% of reoperations were for recurrent stenosis or progressive spondylolisthesis, 25% for complication or other reason, and 16% for new condition. Of patients who underwent a reoperation, 42% did so within 2 years, 70% within 4 years, and 84% within 6 years. Patients who underwent reoperation were less likely to have presented with any neurological deficit (43% reop vs. 57% no reop, P = 0.04). Patients improved less at follow-up in the reoperation group (P < 0.001). In patients undergoing surgical treatment for SpS, the reoperation rate at 8-year follow-up was 18%. Patients with a reoperation were less likely to have a baseline neurological deficit. Patients who did not undergo reoperation had better patient reported outcomes at 8-year follow-up compared with those who had repeat surgery. 2.

Effect of Expectations on Treatment Outcome for Lumbar Intervertebral Disc Herniation.

Secondary analysis of randomized and nonrandomized prospective cohorts. To examine the effect of patient treatment expectations on treatment outcomes for patients with intervertebral disc herniation. Patient expectations about treatment effectiveness may have important relationships with clinical outcomes. Subgroup and reanalysis of the Spine Patient Outcomes Research Trial, a randomized trial and comprehensive cohort study enrolling patients between March 2000 and November 2004 from 13 multidisciplinary spine clinics in 11 US states. Overall, 501 randomized and 744 observational patients (1244 total) who were surgical candidates with radiculopathy and imaging confirmed lumbar intervertebral disc herniation were enrolled. The primary study compared surgical discectomy to usual nonoperative care; this subgroup analysis reassessed outcomes on the basis of treatment expectations at baseline. Expectations about symptomatic and functional improvement for both surgery and nonoperative care were assessed on 5-point scales (1="No Chance (0%)" to 5="Certain (100%)"). Outcomes were assessed using longitudinal regression models analyzed by treatment received. Among 1244 IDH SPORT participants, 1168 provided data on both outcomes and baseline expectations and were included in the current analysis: 467 from the randomized and 701 from the observational cohort. Low expectations of outcomes with surgery predicted poorer outcome regardless of treatment. High expectations of outcomes with nonoperative care predicted better nonoperative outcomes but did not affect surgical results. These differences were of similar magnitude to the difference in outcomes between surgery and nonoperative care. High expectations of treatment benefit had clinically significant positive associations with outcomes. 2.

More nerve root injuries occur with minimally invasive lumbar surgery, especially extreme lateral interbody fusion: A review.

Background:In the lumbar spine, do more nerve root injuries occur utilizing minimally invasive surgery (MIS) techniques versus open lumbar procedures? To answer this question, we compared the frequency of nerve root injuries for multiple open versus MIS operations including diskectomy, laminectomy with/without fusion addressing degenerative disc disease, stenosis, and/or degenerative spondylolisthesis.Methods:Several of Desai et al. large Spine Patient Outcomes Research Trial studies showed the frequency for nerve root injury following an open diskectomy ranged from 0.13% to 0.25%, for open laminectomy/stenosis with/without fusion it was 0%, and for open laminectomy/stenosis/degenerative spondylolisthesis with/without fusion it was 2%.Results:Alternatively, one study compared the incidence of root injuries utilizing MIS transforaminal lumbar interbody fusion (TLIF) versus posterior lumbar interbody fusion (PLIF) techniques; 7.8% of PLIF versus 2% of TLIF patients sustained root injuries. Furthermore, even higher frequencies of radiculitis and nerve root injuries occurred during anterior lumbar interbody fusions (ALIFs) versus extreme lateral interbody fusions (XLIFs). These high frequencies were far from acceptable; 15.8% following ALIF experienced postoperative radiculitis, while 23.8% undergoing XLIF sustained root/plexus deficits.Conclusions:This review indicates that MIS (TLIF/PLIF/ALIF/XLIF) lumbar surgery resulted in a higher incidence of root injuries, radiculitis, or plexopathy versus open lumbar surgical techniques. Furthermore, even a cursory look at the XLIF data demonstrated the greater danger posed to neural tissue by this newest addition to the MIS lumbar surgical armamentariu. The latter should prompt us as spine surgeons to question why the XLIF procedure is still being offered to our patients?

Recurrence of Pain After Usual Nonoperative Care for Symptomatic Lumbar Disk Herniation: Analysis of Data From the Spine Patient Outcomes Research Trial

ObjectiveTo determine risks and predictors of recurrent leg and low back pain (LBP) after unstructured, usual nonoperative care for subacute/chronic symptomatic lumbar disk herniation (LDH). DesignSecondary analysis of data from a concurrent randomized trial and observational cohort study. SettingThirteen outpatient spine practices. ParticipantsA total of 199 participants with resolution of leg pain and 142 participants with resolution of LBP from among 478 participants receiving usual nonoperative care for symptomatic LDH. Assessment of Risk FactorsPotential predictors of recurrence included time to initial symptom resolution, sociodemographics, clinical characteristics, work-related factors, imaging-detected herniation characteristics, and baseline pain bothersomeness. Main Outcome MeasurementsLeg pain and LBP bothersomeness were assessed by the use of a 0-6 numerical scale at up to 4 years of follow-up. For individuals with initial resolution of leg pain, we defined recurrent leg pain as having leg pain, receiving lumbar epidural steroid injections, or undergoing lumbar surgery subsequent to initial leg pain resolution. We calculated cumulative risks of recurrence by using Kaplan-Meier survival plots and examined predictors of recurrence using Cox proportional hazards models. We used similar definitions for LBP recurrence. ResultsOne- and 3-year cumulative recurrence risks were 23% and 51% for leg pain, and 28% and 70% for LBP, respectively. Early leg pain resolution did not predict future leg pain recurrence. Complete leg pain resolution (adjusted hazard ratio [aHR] 0.47, 95% confidence interval [CI] 0.31-0.72) and posterolateral herniation location (aHR 0.61; 95% CI 0.39-0.97) predicted a lower risk of leg pain recurrence, and joint problems (aHR 1.89; 95% CI 1.16-3.05) and smoking (aHR 1.81; 95% CI 1.07-3.05) predicted a greater risk of leg pain recurrence. For participants with complete initial resolution of pain, recurrence risks at 1 and 3 years were 16% and 41% for leg pain and 24% and 59% for LBP, respectively. ConclusionsRecurrence of pain is common after unstructured, usual nonsurgical care for LDH. These risk estimates depend on the specific definitions applied, and the predictors identified require replication in future studies.

The Effect of Epidural Steroid Injection on Postoperative Outcome in Patients From the Lumbar Spinal Stenosis Outcome Study.

Retrospective analysis of data from patients participating in the Lumbar Spinal Stenosis Outcome Study (LSOS). The aim of LSOS was to assess clinical outcomes after surgical or nonoperative treatment in patients with and without prior epidural steroid injections. Epidural steroid injections (ESI), a common treatment modality, reduce symptoms in the short-term, but according to a subgroup analysis from the Spine Patient Outcomes Research Trial (SPORT) they reduce the amount of improvement after subsequent surgical or nonoperative treatment. The data of 281 patients with lumbar spinal stenosis who had completed baseline and 6-month follow-up assessments were analyzed. Patients completed the Spinal Stenosis Measure (SSM). Changes in the SSM scores from baseline to follow-up were compared between patients with and without prior ESI, for the surgical and nonsurgical treatment groups. The mean (SD) age of the patients was 75 (8.7) years. 229 patients underwent surgery and 111 of these had received an ESI in the 12 months before surgery. Of the 52 patients treated nonoperatively, 29 had received a prior ESI. The unadjusted changes (improvement) in the SSM-symptom scores between baseline and 6 months' follow up were: surgery and prior ESI 0.95, surgery and no prior ESI 0.78 (P = 0.15); no surgery and prior ESI 0.28, no surgery and no prior ESI 0.29 (P = 0.85). When adjusted for confounding factors, the reduction in SSM-symptom score was greater for surgery than for nonoperative treatment by 0.41 points (P < 0.001); the effect of having had an ESI prior to study entry was -0.08 (P = 0.40). The analysis of outcomes in the LSOS cohort provided no evidence that ESIs have a negative effect on the short-term outcome of surgery or nonoperative treatment in patients with lumbar spinal stenosis. 3.

Degenerative Spondylolisthesis.

Degenerative spondylolisthesis (DS) is one of the more commonly encountered spine conditions. The diagnosis of DS has changed little in the last 30 years. However, there has been an evolution in the treatment of this disease entity. There have been several landmark papers that helped govern our treatment. These helped serve as the basis for the treatment arms of the Spine Patient Outcomes Research Trial (SPORT), which offers the highest quality evidence to date. Although few would argue that the fusion of the diseased segment appears to offer the best and most durable results, treatment of this disease is best tailored to the individual. Fusion may offer the best results in the young active patient, but the same results may never become evident in the medically infirm patient. Laminectomy or unilateral laminoforaminotomy still plays a role in disease treatment. This review will focus on the diagnosis and the treatment of DS as well as discuss the author's preferred treatment of this disease.

Nothing Hurts Follow-Up like Follow-Up?

Dear EBSJ Readers, First off, some housekeeping notes. Welcome to the new EBSJ, now combined with Global Spine Journal, and our expanded Editor-in-Chief team with Drs. Jeff Wang and Karsten Wiechert. Please welcome on board our newManaging Editor Danielle Lieberman, who has taken on her new role with much appreciated energy. We would like to thank Thea Swanson for her years of faithful service, and we wish her all the best in her new role as novelist. By combining our resources and outstanding global multispecialty reviewers, we will be able to further expand our readership and offer an ever-increasing variety of peer-reviewed scientific articles from around the world. For EBSJ, we will be able to concentrate even more on our popular in-depth formal systematic reviews as a special service to our AOSpine community. As always, we look forward to your topic suggestions and author inquiries. As an introductory topic to this issue, I would like to recommend to you an article by Lurie et al recently published in Spine, titled “Long-Term Outcomes of Lumbar Spinal Stenosis: Eight-Year Results of the Spine Patient Outcomes Research Trial (SPORT).”1 I encourage you to read this article for several reasons:

Comparison of the lumbar disc herniation patients randomized in SPORT to 6,846 discectomy patients from NSQIP: demographics, perioperative variables, and complications correlate well

Background contextThe Spine Patient Outcomes Research Trial (SPORT) is a highly referenced clinical trial that randomized patients with lumbar pathology to receive surgery or continued conservative treatment. PurposeThe purpose of this study was to compare the SPORT lumbar disc herniation cohort and an analogous cohort from the National Surgical Quality Improvement Program (NSQIP) database. Study design/settingThis is a retrospective cohort study comparing a national database population to a randomized clinical trial. Patient sampleElective lumbar discectomies from NSQIP between 2010 and 2012 were used. Outcome measuresDemographics were compared between the randomized SPORT cohorts (surgical and nonoperative) and NSQIP. Perioperative factors and complications were then compared between SPORT discectomy patients and NSQIP. MethodsUsing current procedural terminology and International Classification of Diseases, ninth revision codes, all elective lumbar discectomies from NSQIP between 2010 and 2012 were identified. Where possible based on the published data and variables available in each cohort, the two populations were compared. ResultsA total of 6,846 NSQIP discectomy patients were compared with the randomized SPORT surgical and nonoperative cohorts. Demographic comparisons showed that NSQIP patients were older (average age 48.2±14.5 years [mean±standard deviation] vs. 41.7±11.8 and 43.0±11.3 years, respectively [p<.001]) and had higher body mass index (29.6±6.2 kg/m2 vs. 27.8±5.6 and 28.2±5.4 kg/m2, respectively [p<.001]). No statistical differences existed for gender or race. Smoking status was not different between the SPORT nonoperative group and NSQIP but was higher in NSQIP compared with SPORT surgical patients (p=.020 by 7%). Comparisons of perioperative factors and complications between the SPORT surgical cohort and NSQIP showed no statistical difference in average operative time, length of stay, deep wound infections, wound dehiscence, total wound complications, or blood transfusions. Spine Patient Outcomes Research Trial superficial wound infection rates were higher than NSQIP (p=.029 by 1.4%). As expected, SPORT 1-year reoperation rates were higher than NSQIP 30-day rates (7% vs. 2%, p<.001). ConclusionsSpine Patient Outcomes Research Trial lumbar disc herniation results are similar to those from a large national patient sample. Even statistically significant differences would be considered clinically similar. These findings support the generalizability of the SPORT lumbar disc herniation results.

The SPORT value compass: do the extra costs of undergoing spine surgery produce better health benefits?

The Spine Patient Outcomes Research Trial aimed to determine the comparative effectiveness of surgical care versus nonoperative care by measuring longitudinal values: outcomes, satisfaction, and costs. This paper aims to summarize available evidence from the Spine Patient Outcomes Research Trial by addressing 2 important questions about outcomes and costs for 3 types of spine problem: (1) how do outcomes and costs of spine patients differ depending on whether they are treated surgically compared with nonoperative care? (2) What is the incremental cost per quality adjusted life year for surgical care over nonoperative care? After 4 years of follow-up, patients with 3 spine conditions that may be treated surgically or nonoperatively have systematic differences in value endpoints. The average surgical patient enjoys better health outcomes and higher treatment satisfaction but incurs higher costs. Spine care is preference sensitive and because outcomes, satisfaction, and costs vary over time and between patients, data on value can help patients make better-informed decisions and help payers know what their dollars are buying.