Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study.

BACKGROUND: Damaged or degenerated vertebral endplates are a significant cause of vertebrogenic chronic low back pain (CLBP). Modic changes are one objective MRI biomarker for these patients. Prior data from the treatment arm of a sham-controlled, RCT showed maintenance of clinical improvements at 2 years following ablation of the basivertebral nerve (BVN). This study reports 5-year clinical outcomes. METHODS: In total, 117 US patients were treated successfully with BVN ablation. Patient-reported outcomes of ODI, VAS, postablation treatments, and patient satisfaction were collected at a minimum of 5-years following BVN ablation. Primary outcome was mean change in ODI. Comparisons between the postablation and baseline values were made using an analysis of covariance with alpha 0.05. RESULTS: Of the 117 US treated patients 100 (85%) were available for review with a mean follow-up of 6.4 years (5.4-7.8 years). Mean ODI score improved from 42.81 to 16.86 at 5-year follow-up, a reduction of 25.95 points (p < 0.001). Mean reduction in VAS pain score was 4.38 points (baseline of 6.74, p < 0.001). In total, 66% of patients reported a > 50% reduction in pain, 47% reported a > 75% reduction in pain, and 34% of patients reported complete pain resolution. Composite responder rate using thresholds of ≥ 15-point ODI and ≥ 2-point VAS for function and pain at 5 years was 75%. CONCLUSION: CLBP patients treated with BVN ablation exhibit sustained clinical improvements in function and pain with high responder rates at a mean of 6.4 years following treatment. BVN ablation is a durable, minimally invasive treatment for vertebrogenic CLBP.

Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study.

PURPOSE: To evaluate the safety and efficacy of radiofrequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of chronic low back pain (CLBP) in a Food and Drug Administration approved Investigational Device Exemption trial. The BVN has been shown to innervate endplate nociceptors which are thought to be a source of CLBP. METHODS: A total of 225 patients diagnosed with CLBP were randomized to either a sham (78 patients) or treatment (147 patients) intervention. The mean age within the study was 47 years (range 25-69) and the mean baseline ODI was 42. All patients had Type I or Type II Modic changes of the treated vertebral bodies. Patients were evaluated preoperatively, and at 2 weeks, 6 weeks and 3, 6 and 12 months postoperatively. The primary endpoint was the comparative change in ODI from baseline to 3 months. RESULTS: At 3 months, the average ODI in the treatment arm decreased 20.5 points, as compared to a 15.2 point decrease in the sham arm (p = 0.019, per-protocol population). A responder analysis based on ODI decrease ≥ 10 points showed that 75.6% of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months. CONCLUSION: Patients treated with RF ablation of the BVN for CLBP exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain. These slides can be retrieved under Electronic Supplementary Material.

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.

Cement augmentation in vertebral burst fractures.

As a result of axial compression, traumatic vertebral burst fractures disrupt the anterior column, leading to segmental instability and cord compression. In situations with diminished anterior column support, pedicle screw fixation alone may lead to delayed kyphosis, nonunion, and hardware failure. Vertebroplasty and kyphoplasty (balloon-assisted vertebroplasty) have been used in an effort to provide anterior column support in traumatic burst fractures. Cited advantages are providing immediate stability, improving pain, and reducing hardware malfunction. When used in isolation or in combination with posterior instrumentation, these techniques theoretically allow for improved fracture reduction and maintenance of spinal alignment while avoiding the complications and morbidity of anterior approaches. Complications associated with cement use (leakage, systemic effects) are similar to those seen in the treatment of osteoporotic compression fractures; however, extreme caution must be used in fractures with a disrupted posterior wall.

Association of Poor Bone Quality with Pseudarthrosis and Poor Clinical Outcomes in Single-Level Instrumented Lumbar Arthrodesis Using Local Autologous Bone Graft.

INTRODUCTION: Although osteoporosis and low bone mineral density is thought to lead to poor fusion outcomes, few studies have adequately addressed the correlation, and they were limited by small sample size at a single institution. METHODS: We completed a secondary analysis of 182 patients enrolled at 26 spine centers across the United States in the EXO-SPINE FDA-approved clinical trial with 12-month CT-based fusion status determined by two independent, blinded radiologists. Using previously described CT-based techniques, we measured local and global Hounsfield units (HU) and examined the relationship with radiographic and clinical outcomes. RESULTS: CT scans were available for review from 95 patients, with a mean age of 56.2 years and mean global density of 153.0 HU. No relationship was observed between HU and radiographic fusion status or clinical outcomes. Although 12% of patients had lumbar vertebral body HU measurements consistent with osteoporosis, this classification had no relation with fusion or clinical outcomes. Patients with pseudarthrosis had higher Oswestry Disability Index (22.2 vs. 16.6, P = 0.037) and back pain visual analog scale (7.0 vs. 4.9, P = 0.014) scores than patients with at least unilateral fusion at the 12-month follow-up. DISCUSSION: In this large, multicenter study, lower vertebral body HU was not associated with worse fusion status after single-level instrumented posterolateral lumbar fusion using only local autologous bone graft. However, there was an association between radiographic fusion status and clinical outcomes, validating the importance of determining predictors of successful fusion. Assessment of fusion status with CT scans yielded a much lower fusion success rate with local bone graft than previously reported and may warrant additional investigation.

Comparison of axial and anterior interbody fusions of the L5-S1 segment: a retrospective cohort analysis.

STUDY DESIGN: Retrospective, multicenter review of 96 patients who underwent L5-S1 interbody fusions through either a standard anterior retroperitoneal approach or using a novel device inserted through the presacral space (AxiaLIF) in conjunction with supplemental posterior fixation between 2002 and 2010. OBJECTIVE: To compare the radiographic fusion rates and adverse events associated with anterior lumbar interbody fusion (ALIF) and AxiaLIF techniques. SUMMARY OF BACKGROUND DATA: Interbody fusions of the lumbosacral spine are frequently performed to provide anterior column support, increase the amount of surface area for bone formation, and facilitate deformity reduction. A number of different surgical approaches have been developed for this purpose including minimally invasive techniques. MATERIALS AND METHODS: Patient information and procedural data were obtained from hospital charts. Multiplanar computed tomography images were evaluated by 2 independent observers to assess fusion success at 24 months using a 4-point grading scale. In addition to reviewing the medical records to identify any complications, all of the sites were queried regarding any device-related adverse events that may have occurred. RESULTS: According to the radiographic analysis, the arthrodesis rates recorded for the ALIF and AxiaLIF cohorts were 79% and 85%, respectively (P>0.05). The numbers and types of adverse events recorded for these procedures appeared to be similar although there was 1 serious intraoperative complication (iliac artery laceration) noted in the ALIF group. CONCLUSIONS: The radiographic success and adverse events associated with AxiaLIF appear to be similar to that observed for ALIF, suggesting that this technique represents a safe and effective method for achieving an interbody fusion across the L5-S1 disk space when utilized in conjunction with posterior fixation.

Clinical Significance of Lateral Pedicle Screw Malposition in Lumbar Spine Fusion.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Our objective was to determine whether lateral pedicle screw breach affects fusion rates and patient-reported outcomes in lumbar fusion surgery. SUMMARY OF BACKGROUND DATA: Although lateral pedicle screw malposition is considered relatively benign, few studies have focused specifically on clinical outcomes or fusion rates associated with lateral screw malposition. METHODS: Twelve-month postoperative computed tomography scans were reviewed for lateral breach, severity of breach, and fusion status. Patients with lateral breach were compared with patients with no breach. Outcome measures included Numerical Pain Rating Scale for back and leg pain, Oswestry Disability Index, and SF-36 physical function (SF-36 PF). Multivariable linear and logistic regression and were adjusted for age, procedure, level, and/or baseline pain score. RESULTS: Forty-five patients (31%) demonstrated 1 or more lateral breaches as compared with 99 patients without breach. After adjusting for baseline scores and fusion level, patients with 2 or more screw breaches experienced SF-36 PF score improvements that were 3.43 points less ( P =0.016) than patients with no lateral breach. After adjusting for baseline Numerical Pain Rating Scale, there was also a significant decrease in the odds of achieving minimally clinical important difference in back pain relief in these patients. There was no observed effect of lateral breach on the odds of successful fusion. CONCLUSIONS: The current study did not observe an association between laterally malpositioned pedicle screws and nonunion. However, results are consistent with a negative effect on SF-36 PF scores and self-reported back pain at 12 months.

Spinal cord position in adolescent idiopathic scoliosis.

BACKGROUND: The use of thoracic pedicle screws in deformity surgery provides a stable fixation system. The concept of acceptably positioned screws includes a worrisome subset of screws that perforate the medial pedicle cortex and may result in some compromise of the spinal canal. A significant higher incidence of cortical wall penetration on the concave side compared with the convex was previously found. Although several authors assumed that the spinal cord hugs the concave pedicles when the spinal deformity is scoliosis, the position of spinal cord in adolescent idiopathic scoliosis (AIS) has not been studied in depth. METHODS: We reviewed 45 patients who were candidate for operative treatment for AIS between August 2007 and October 2010 at our institution. Posteroanterior and lateral 3-ft standing preoperative radiographs of the spine were reviewed to determine: Cobb angle of the thoracic curves, apex vertebra of the curves, and end vertebras of the curves. Magnetic resonance images were retrospectively reviewed. The lateral cord space (LCS) ratio, which reflects the relative position of the spinal cord in the spinal canal, was calculated for each level with a thoracic curve. RESULTS: The average LCS for thoracic curves of >50 degrees was 2.123. The average LCS for thoracic curves of <50 degrees was 1.551 (P=0.002). The LCS for the apex vertebra was 1.699. The LCS for the upper end vertebra and lower end vertebra were 1.212, 1.225, respectively (P<0.001). There was a statistically significant difference between right thoracic curves and left thoracic curve regarding the LCS. In right thoracic curve the LCS was 1.487 (1.487+0.45) while in left thoracic curve it was 0.761 (0.761+0.17) meaning that in both curves the spinal cord moved to the concave side of the curve. CONCLUSIONS: Our study confirms that spinal cord in AIS tend to follow the appearance of the curve with its being tethered on the concave side. The spinal cord is close to the pedicle around the apex area.

Intradiscal Delivery of Anabolic Growth Factors and a Metalloproteinase Inhibitor in a Rabbit Acute Lumbar Disc Injury Model.

BACKGROUND: The purpose of our study was to examine the effect of controlled delivery of TGF-ß3, BMP-4, and TIMP-2 with a biocompatible biopolymer, chitosan, on an acutely injured intervertebral disc (IVD) in a rabbit model. METHODS: After conducting an in vitro analysis of the chondrogenic capacity of the biomolecule cocktail use (ie, TGF-ß3, BMP-4, and TIMP-2) and confirming stem cell viability in chitosan hydrogel, 15 New Zealand white rabbits underwent a lateral approach of the L1 to L4 IVDs. In each rabbit, the L2 to L3 IVD was left pristine, whereas the L1 to L2 and the L3 to L4 IVDs in each rabbit underwent nucleotomy via a 25-G needle, and the animal was subsequently randomized to no further treatment (defect only), chitosan alone, Chitosan + TGF-ß3 + BMP-4, or chitosan + TGF-ß3 + BMP-4 + TIMP-2. At 6 weeks after injury and intervention, the rabbits were killed and spines harvested to undergo quantitative T2 magnetic resonance imaging (MRI) and subsequent histologic analysis. RESULTS: In the in vitro analysis, cells treated with experimental media containing TGF-ß3, BMP-4, and TIMP-2 exhibited staining indicative of GAG production and began to exhibit a chondrocytic morphology. Quantitative T2 MRI mapping demonstrates that discs treated with chitosan, chitosan containing TGF-ß3 and BMP-4, or chitosan containing TGF-ß3, BMP-4, and TIMP-2 had consistently higher T2 relaxation times compared with defect-only discs. When the T2 relaxation times of each treatment group and defect-only discs were normalized to the healthy control disc, it was found that the T2 relaxation time of discs treated with chitosan containing TGF-ß3 and BMP-4 and discs treated with chitosan containing TGF-ß3, BMP-4, and TIMP-2 were significantly greater compared with defect-only discs (P = .048 and P = .013, respectively). Histologically, animals that received chitosan only, or chitosan with TGF-ß3 and BMP-4, showed a significantly higher intensity of Safranin-O staining (P = .016 and P = .02, respectively) compared with control discs, whereas the difference in staining intensity in animals that received chitosan loaded with TGF-ß3, BMP-4, and TIMP-2 failed to achieve significance (P = .161). CONCLUSIONS: A combination of chitosan, TGF-ß3, and BMP-4 was effective at promoting regeneration in an acute disc injury rabbit model, whereas TIMP-2 did not have a significant effect.

Association Between Opioid Use and Patient-Reported Outcomes in a Randomized Trial Evaluating Basivertebral Nerve Ablation for the Relief of Chronic Low Back Pain.

BACKGROUND: Chronic low back pain (CLBP) is a primary indication for opioid therapy. OBJECTIVE: To evaluate the hypothesis that CLBP patients reporting reduced opioid use have superior functional outcomes following basivertebral nerve (BVN) radiofrequency ablation. METHODS: This post hoc analysis from a sham-controlled trial examined short-acting opioid use from baseline through 1 yr. Opioid use was stratified into 3 groups by two blinded external reviewers. Two-sample t-tests were used to compare Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) measurements between those patients who increased or decreased their opioid usage compared to baseline. RESULTS: Actively treated patients with decreased opioid use at 12 mo had a mean ODI improvement of 24.9 ± 16.0 (n = 27) compared to 7.3 ± 9.8 (n = 18) for patients reporting increased opioid use (P < .001). In the sham arm, the improvements in ODI were 17.4 ± 16.1 (n = 19) and 1.2 ± 14.3 (n = 5; P = .053) for the patients reporting decreased vs increased opioid usage, respectively. Actively treated patients reporting decreased opioid use had a mean improvement in VAS of 3.3 ± 2.5 (n = 27) compared to 0.6 ± 1.8 (n = 18) for patients reporting increased opioid use (P < .001). In the sham arm, the improvements in VAS were 2.5 ± 2.6 (n = 19) and 1.4 ± 1.9 (n = 5; P = .374) for patients reporting decreased vs increased opioid use, respectively. CONCLUSION: Subjects undergoing BVN ablation who decreased opioid use had greater improvement in ODI and VAS scores compared with those reporting increased opioid usage. There is an association between functional benefit from BVN ablation and reduced opioid use.

Cutibacterium acnes in Spine Pathology: Pathophysiology, Diagnosis, and Management.

Cutibacterium acnes, long thought to be skin flora of pathological insignificance, has seen a surge in interest for its role in spine pathology. C acnes has been identified as a pathogen in native spine infection and osteomyelitis, which has implications in the management compared with more commonly recognized pathogens. In addition, It has also been recognized as a pathogen in postoperative and implant-associated infections. Some evidence exists pointing to C acnes as an unrecognized source of otherwise aseptic pseudarthrosis. Recently, it is hypothesized that low virulent organisms, in particular C acnes, may play a role in degenerative disk disease and the development of Modic end plate changes found in MRI. To this end, controversial implications exist in terms of the use of antibiotics to treat certain patients in the setting of degenerative disk disease. C acnes continues to remain an expanding area of interest in spine pathology, with important implications for the treating spine surgeon.

Lumbar Spine Fusion Rates With Local Bone in Posterolateral and Combined Posterolateral and Interbody Approaches.

Posterolateral lumbar fusion (PLF) used to treat degenerative lumbar conditions still faces pseudarthrosis. Bone graft choice is a key factor; a traditional choice has been autologous iliac crest bone graft (ICBG), but complication rates are quoted up to 39%. Local bone from laminectomy eliminates ICBG harvesting complications. METHODS: Two hundred forty-one patients underwent either PLF or PLF with interbody at a single lumbar level with a prospective, multicenter, randomized controlled trial only using local bone graft. Fusion was assessed with radiographs and CT. RESULTS: PLF fused bilaterally in 18% and unilaterally in 28.8% at 6 months and 35.7% and 50.3% at 12 months, respectively. At 6-month PLF + interbody, 1.1% fused bilaterally and 11.7% unilaterally; at 12 months, 5.4% fused all three areas, and 50.8% fused at least one area. DISCUSSION: Local bone fused substantially less than the "benchmark" ICBG.

Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study.

BACKGROUND: The purpose of the present study is to report the 2-year clinical outcomes for chronic low back pain (CLBP) patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) in a randomized controlled trial that previously reported 1-year follow up. METHODS: A total of 147 patients were treated with RF ablation of the BVN in a randomized controlled trial designed to demonstrate safety and efficacy as part of a Food and Drug Administration-Investigational Device Exemption trial. Evaluations, including patient self-assessments, physical and neurological examinations, and safety assessments, were performed at 2 and 6 weeks, and 3, 6, 12, 18, and 24 months postoperatively. Participants randomized to the sham control arm were allowed to cross to RF ablation at 12 months. Due to a high rate of crossover, RF ablation treated participants acted as their own control in a comparison to baseline for the 24-month outcomes. RESULTS: Clinical improvements in the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and the Medical Outcomes Trust Short-Form Health Survey Physical Component Summary were statistically significant compared to baseline at all follow-up time points through 2 years. The mean percent improvements in ODI and VAS compared to baseline at 2 years were 53.7 and 52.9%, respectively. Responder rates for ODI and VAS were also maintained through 2 years with patients showing clinically meaningful improvements in both: ODI ≥ 10-point improvement in 76.4% of patients and ODI ≥ 20-point improvement in 57.5%; VAS ≥ 1.5 cm improvement in 70.2% of patients. CONCLUSIONS: Patients treated with RF ablation of the BVN for CLBP exhibited sustained clinical benefits in ODI and VAS and maintained high responder rates at 2 years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of CLBP.

The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft for posterolateral lumbar arthrodesis: minimum 4-year follow-up of a pilot study.

BACKGROUND CONTEXT: Although autogenous bone is still considered to be the gold standard graft material for promoting spinal fusion, other bone graft substitutes have been developed in an attempt to improve arthrodesis rates and avoid the complications associated with the procurement of autograft. The bone morphogenetic proteins (BMPs) represent a family of osteoinductive growth factors that are known to stimulate the osteoblastic differentiation of stem cells. Osteogenic protein-1 (OP-1) Putty is a commercially available BMP preparation that is already approved for use in humans. Previous clinical studies involving patients with degenerative spondylolisthesis have reported that the efficacy and safety of OP-1 Putty is comparable to that of autograft at both 1- and 2-year follow-up. PURPOSE: The purpose of this study was to evaluate the intermediate-term efficacy and safety of OP-1 Putty as an alternative to autogenous bone by comparing the 4-year radiographic, clinical, and safety data of these same patients who underwent decompression and uninstrumented fusion with either OP-1 Putty or iliac crest autograft. STUDY DESIGN/SETTING: A prospective, randomized, controlled, multicenter clinical pilot study. PATIENT SAMPLE: Thirty-six patients undergoing decompressive laminectomy and single-level uninstrumented fusion for degenerative spondylolisthesis and symptomatic spinal stenosis were randomized in a 2:1 fashion to receive either OP-1 Putty (24 patients) or autogenous iliac crest bone graft (12 patients). OUTCOME MEASURES: Patient-reported outcome measures consisting of Oswestry Disability Index and Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) scores were used to evaluate clinical efficacy. Perioperative data including operative time, estimated blood loss, and duration of hospital stay were also recorded for each surgery. Postoperatively, a neurological examination and an assessment of donor-site pain (if applicable) were performed at every follow-up visit. Radiographic fusion success was defined as the presence of continuous bridging bone formation between the transverse processes at the level of the spondylolisthesis with minimal motion evident on dynamic lateral x-ray films. The primary efficacy endpoint was the overall success rate, a composite measure derived from both radiographic and clinical parameters. The safety of OP-1 Putty was confirmed by comparing the nature and frequency of all adverse events and complications that were prospectively observed in either of the groups. METHODS: Thirty-six patients with degenerative spondylolisthesis and symptoms of neurogenic claudication underwent decompressive laminectomy and single-level uninstrumented fusion with either OP-1 Putty or autograft. All patients were evaluated at 6 weeks and 3, 6, 9, 12, and 24 months, after which time they were instructed to return on a yearly basis. Multiple neuroradiologists blinded to the assigned treatment reviewed static and dynamic X-ray films with digital calipers to assess fusion status according to the presence of continuous bridging bone across the transverse processes as well as the amount of residual motion evident at the level of interest. Oswestry Disability Index surveys and SF-36 questionnaires were used to assess clinical outcomes. RESULTS: At the 48-month time point, complete radiographic and clinical data were available for 22 of 36 patients (16 OP-1 Putty and 6 autograft) and 25 of 36 patients (18 OP-1 Putty and 7 autograft), respectively. Radiographic evidence of a solid arthrodesis was present in 11 of 16 OP-1 Putty patients (68.8%) and 3 of 6 autograft patients (50%). Clinically successful outcomes defined as at least a 20% improvement in preoperative Oswestry scores were experienced by 14 of 19 OP-1 Putty patients (73.7%) and 4 of 7 autograft patients (57.1%); these clinical findings were corroborated by similar increases in SF-36 scores. The respective overall success rates of the OP-1 Putty and autograft group were 62.5% and 33.3%. In this study, there were no incidents of local or systemic toxicity, ectopic bone production, or other adverse events directly related to the use of OP-1 Putty. CONCLUSION: Despite the challenges associated with obtaining a solid uninstrumented fusion in patients with degenerative spondylolisthesis, the rates of radiographic fusion, clinical improvement, and overall success associated with the use of OP-1 Putty were at least comparable to that of the autograft controls for at least 48 months after surgery. These results appear to validate the short-term results previously reported for OP-1 Putty and suggest that this material may potentially represent a viable bone graft substitute for certain fusion applications.

Degenerative lumbar spondylolisthesis: trends in management.

Degenerative spondylolisthesis with spinal stenosis is common in elderly patients. When symptomatic, the resultant neurogenic claudication often leads to a diminished quality of life. A nonsurgical approach is an appropriate first step. Maximizing the chance of a solid arthrodesis improves the possibility of a successful long-term outcome. Treatment of this pathology has evolved over the past twenty years with the publication of numerous prospective randomized trials assessing the influence of fusion and instrumentation following decompression. Current prospective trials have evaluated the use of bone morphogenetic proteins as a substitute for autogenous bone graft. Recently, soft-tissue stabilization devices have been advocated as an alternative to fusion. Clinicians should critically evaluate these newer technologies and exercise caution regarding their use until controlled long-term trials are completed.