Longitudinal Analysis of the Care Pathway of Patients with Lumbar Spinal Stenosis in the US.

Background: Evidence regarding the frequency and timing of treatment for lumbar spinal stenosis (LSS) fails to offer clear consensus. We describe the LSS care journey from initial diagnosis to first surgical intervention. Methods: Using Medicare claims database from 2009 through 2020, we identified patients who were diagnosed with LSS. The use and timing of conservative and surgical treatments during the entire follow-up from the initial diagnosis were reported. Results: Of the 143,849 patients identified, 68% received conservative care within 8.4 months and 25.3% received a surgical or minimally invasive intervention over 5.7 years following initial diagnosis, with 12.6% undergoing open decompression alone, 10.2% undergoing open decompression with fusion, and 5.1% undergoing fusion surgery alone. Fewer than 1% were provided with interspinous spacers or a percutaneous image-guided lumbar decompression. Conclusion: Approximately three-quarters of patients in the study received no surgical or non-invasive interventions for approximately six years following diagnosis with LSS.

Biomechanical investigation of a customized interspinous spacer system in the treatment of degenerative disc diseases: A finite element analysis.

BACKGROUND: A novel interspinous fixation system based on anatomical parameters and incorporating transfacetopedicular screws, was developed to treat degenerative disc diseases. The biomechanical characteristics of the novel system were evaluated using finite element analysis in comparison to other classical interspinous spacers. METHODS: The L1-S1 lumbar spine finite element models were surgically implanted with the novel system, Coflex and DIAM devices at the L4/L5 segment to assess the range of motion, the pression distribution of intervertebral disc, the peak stresses on the spinous process and implant during various motions. FINDINGS: Range of motions of the L4/L5 surgical segment were reduced by 29.13%, 61.27%, 77.35%, 33.33%, and the peak stresses of intervertebral disc were decreased by 36.82%, 67.31%, 73.00%, 69.57% for the novel system in flexion, extension, lateral bending, and axial rotation when compared with the Coflex, and they were declined by 34.53%, 57.86%, 75.81%, 25.21%; 36.22%, 67.31%, 75.01%, 71.40% compared with DIAM. The maximum stresses of the spinous process were 29.93 MPa, 24.66 MPa, 14.45 MPa, 24.37 MPa in the novel system, and those of Coflex and DIAM were 165.3 MPa, 109 MPa, 84.79 MPa, 47.66 MPa and 52.59 MPa, 48.78 MPa, 50.27 MPa, 44.16 MPa during the same condition. INTERPRETATION: Compared to other interspinous spacer devices, the novel interspinous fixation system demonstrated excellent stability, effectively distributing load on the intervertebral disc, and reducing the risk of spinous process fractures. The personalized design of the novel interspinous fixation system could be a viable option for treating degenerative disc diseases.

A Biomechanical Comparison of 2 Different Topping-off Devices and Their Influence on the Sacroiliac Joint Following Lumbosacral Fusion Surgery.

OBJECTIVE: Interspinous spacer (ISS)-based and pedicle screw-rod dynamic fixator (PDF)-based topping-off devices have been applied in lumbar/lumbosacral fusion surgeries for preventing the development of proximal adjacent segment degeneration. However, little attention has been paid to sacroiliac joint (SIJ), which belongs to the adjacent joints. Accordingly, the objective of this study was to compare how these 2 topping-off devices affect the SIJ biomechanics. METHODS: A validated, normal finite-element lumbopelvic model (L3-pelvis) was initially adjusted to simulate interbody fusion with rigid fixation at the L5-S1 level, and then the DIAM or BioFlex system was instrumented at the L4-5 level to establish the ISS-based or PDF-based topping-off model, respectively. All the developed models were loaded with moments of 4 physiological motions using hybrid loading protocol. RESULTS: Compared with the rigid fusion model (without topping-off devices), range of motion and von-Mises stress at the SIJs were increased by 23.1%-64.1% and 23.6%-62.8%, respectively, for the ISS-based model and by 51.2%-126.7% and 50.4%-108.7%, respectively, for the PDF-based model. CONCLUSION: The obtained results suggest that the PDF-based topping-off device leads to higher increments in SIJ motion and stress than ISS-based topping-off device following lumbosacral fusion, implying topping-off technique could be linked to an increased risk of SIJ degeneration, especially when using PDF-based device.

Longitudinal Comparative Analysis of Complications and Subsequent Interventions Following Stand-Alone Interspinous Spacers, Open Decompression, or Fusion for Lumbar Stenosis.

INTRODUCTION: For individuals with lumbar spinal stenosis (LSS), minimally invasive procedures such as an interspinous spacer device without decompression or fusion (ISD) or open surgery (i.e., open decompression or fusion) may relieve symptoms and improve functions when patients fail to respond to conservative therapies. This research compares longitudinal postoperative outcomes and rates of subsequent interventions between LSS patients treated with ISD and those with open decompression or fusion as their first surgical intervention. METHODS: This retrospective, comparative claims analysis identified patients age ≥ 50 years with LSS diagnosis and with a qualifying procedure during 2017-2021 in the Medicare database which includes healthcare encounters in inpatient and outpatient settings. Patients were followed from the qualifying procedure until end of data availability. The outcomes assessed during the follow-up included subsequent surgical interventions, including subsequent fusion and lumbar spine surgeries, long-term complications, and short-term life-threatening events. Additionally, the costs to Medicare during a 3-year follow-up were calculated. Cox proportional hazards, logistic regression, and generalized linear models were used to compare outcomes and costs, adjusted for baseline characteristics. RESULTS: A total of 400,685 patients who received a qualifying procedure were identified (mean age 71.5 years, 50.7% male). Compared to ISD patients, patients receiving open surgery (i.e., decompression and/or fusion) were more likely to have a subsequent fusion [hazard ratio (HR), 95% confidence intervals (CI): 1.49 (1.17, 1.89)-2.54 (2.00, 3.23)] or other lumbar spine surgery [HR (CI): 3.05 (2.18, 4.27)-5.72 (4.08, 8.02)]. Short-term life-threatening events [odds ratio (CI): 2.42 (2.03, 2.88)-6.36 (5.33, 7.57)] and long-term complications [HR (CI): 1:31 (1.13, 1.52)-2.38 (2.05, 2.75)] were more likely among the open surgery cohorts. Adjusted mean index costs were lowest for decompression alone (US$7001) and highest for fusion alone ($33,868). ISD patients had significantly lower 1-year complication-related costs than all surgery cohorts and lower 3-year all-cause costs than fusion cohorts. CONCLUSIONS: ISD resulted in lower risks of short- and long-term complications and lower long-term costs than open decompression and fusion surgeries as a first surgical intervention for LSS.

Biomechanical analysis of a customized lumbar interspinous spacer based on transfacetopedicular screw fixation: A finite element study.

The interspinous spacer (ISP) is a minimally invasive surgical device implanted into the interspinal space to treat lumbar degenerative diseases. Unfortunately, ISPs sometimes cause device breakage and spinal process fracture. Our aim was to elaborate the design of lumbar customized posterior fixation system (CISP system), encompassing a customized ISP body and transfacetopedicular screws, and examine its biomechanical effect on the lumbar spine using finite element (FE) analysis. We constructed the CISP system, based on the interspinal anatomical data at the surgical level. We generated the L3-S1 FE models, implanted with the polyetheretherketone (PEEK) CISP system, titanium alloy (TI) CISP system, and Coflex device at the L4/L5 segment, and determined the lumbar segmental range of motions (ROMs), intervertebral discs (IVD) peak stress, and implant stresses. The CISP system enhanced mobility restriction at the surgical level, compared to the Coflex device. Furthermore, the IVD peak stress reduction was more obvious in the CISP system than the Coflex device, particularly during extension. Under the same motion mode, the maximum stress on the TI CISP system was smaller than on the Coflex device, but larger than the PEEK CISP system. Given these evidences, PEEK appeared to be a better material for the CISP body.

Clinical and radiological outcomes following insertion of a novel removable percutaneous interspinous process spacer: an initial experience.

PURPOSE: To evaluate clinical and radiological outcomes of a series of patients treated with a removable percutaneous interspinous process spacer (IPS) (LobsterProject® Techlamed®) for symptomatic degenerative lumbar spinal stenosis (DLSS). METHODS: All patients treated in two centres with this IPS during 2019 were retrospectively reviewed. Procedures were performed under deep sedation or general anaesthesia by two interventional radiologists. Patients were clinically evaluated before intervention and at 3-month follow-up with Visual Analog Scales for pain (VAS), Oswestry Disability Index (ODI) and radiologically with MRI or CT scans. Neural foramina were independently measured for each patient on pre- and post-procedural CT scans by two radiologists. RESULTS: Fifty-nine patients were treated in the selected period of which fifty-eight had complete documentation (mean age 71.2 ± 9.2 years [55-92], 32 males, 26 females). Forty-eight interventions were performed under deep sedation and ten under general anaesthesia, without procedural complications. Clinical follow-up at 3 months showed a significant reduction of pain (VAS from 83 ± 9 to 29 ± 19, - 65%; p < 0.001) and an improvement in functional outcomes (ODI from 31 ± 12 to 13 ± 10%, - 58%; p < 0.001). There was one case of unsatisfactory positioning post procedure, two cases of posterior migration at 3-month follow-up and one case of spinous process fracture. Mean neural foramina area increased from 77 ± 23 to 95 ± 27 mm2 (+ 26%; p < 0.001) with very good inter-observer reliability (Cronbach's alpha = 0.899). CONCLUSION: Percutaneous minimally invasive insertion of a removable IPS device demonstrates a favourable safety profile, good clinical outcomes at 3 months, and apparent anatomical increase in foraminal dimensions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05203666-Release Date: 21st January 2022, retrospectively registered.

Biomechanical feasibility of semi-rigid stabilization and semi-rigid lumbar interbody fusion: a finite element study.

BACKGROUND: Semi-rigid lumbar fusion offers a compromise between pedicle screw-based rigid fixation and non-instrumented lumbar fusion. However, the use of semi-rigid interspinous stabilization (SIS) with interspinous spacer and ligamentoplasty and semi-rigid posterior instrumentation (SPI) to assist interbody cage as fusion constructs remained controversial. The purpose of this study is to investigate the biomechanical properties of semi-rigidly stabilized lumbar fusion using SIS or SPI and their effect on adjacent levels using finite element (FE) method. METHOD: Eight FE models were constructed to simulate the lumbosacral spine. In the non-fusion constructs, semi-rigid stabilization with (i) semi-rigid interspinous spacer and artificial ligaments (PD-SIS), and (ii) PI with semi-rigid rods were simulated (PD + SPI). For fusion constructs, the spinal models were implanted with (iii) PEEK cage only (Cage), (iv) PEEK cage and SIS (Cage+SIS), (v) PEEK cage and SPI (Cage+SPI), (vi) PEEK cage and rigid PI (Cage+PI). RESULT: The comparison of flexion-extension range of motion (ROM) in the operated level showed the difference between Cage+SIS, Cage+SPI, and Cage+PI was less than 0.05 degree. In axial rotation, ROM of Cage+SIS were greater than Cage+PI by 0.81 degree. In the infrajacent level, while Cage+PI increased the ROM by 24.1, 27,7, 25.9, and 10.3% and Cage+SPI increased the ROM by 26.1, 30.0, 27.1, and 10.8% in flexion, extension, lateral bending and axial rotation respectively, Cage+SIS only increased the ROM by 3.6, 2.8, and 11.2% in flexion, extension, and lateral bending and reduced the ROM by 1.5% in axial rotation. The comparison of the von Mises stress showed that SIS reduced the adjacent IVD stress by 9.0%. The simulation of the strain energy showed a difference between constructs less than 7.9%, but all constructs increased the strain energy in the infradjacent level. CONCLUSION: FE simulation showed semi-rigid fusion constructs including Cage+SIS and Cage+SPI can provide sufficient stabilization and flexion-extension ROM reduction at the fusion level. In addition, SIS-assisted fusion resulted in less hypermobility and less von Mises stress in the adjacent levels. However, SIS-assisted fusion had a disadvantage of less ROM reduction in lateral bending and axial rotation. Further clinical studies are warranted to investigate the clinical efficacy and safety of semi-rigid fusions.

Perspective: A Proposed Diagnostic and Treatment Algorithm for Management of Lumbar Spinal Stenosis: An Integrated Team Approach.

BACKGROUND: Newly-introduced minimally invasive interventions have filled a gap between conservative care and open surgical procedures in the treatment and management of lumbar spinal stenosis (LSS), allowing expanded access to patient care. This spectrum of care involves an important interplay between advanced practice providers, interventional pain physicians, and spine surgeons. OBJECTIVES: Using an integrated team approach starting with history taking; static and dynamic imaging; and conservative care, we developed a simple, understandable clinical algorithm that serves as a foundation for physicians to confidently make objective decisions regarding diagnosing and treating LSS throughout the entire clinical course of the condition. We believe this could potentially lead to more efficient and effective care for patients suffering from LSS with neurogenic claudication. METHODS: A decision tree approach was utilized with "either/or" choices at each branch or node in the algorithm. Activities are divided into examination procedures and corresponding treatment interventions. Symptom and radiographic severity grading as well as assessing clinical status employed published validated standards. Commensurate treatment choices were selected based on published LSS-specific clinical practice guidelines and/or meta-analyses. RESULTS: This algorithm recommends a systematic rule set for LSS diagnostic and treatment options. Initially, LSS symptom severity is graded based on the patient's pain relief with spinal flexion. This is correlated with radiographic severity assessment graded as mild, moderate, or severe. Radiographic severity combined with dynamic imaging prescribes a choice of treatment options and a risk/benefit discussion with the patient. These options include conservative management, minimally invasive methods such as interspinous process decompression, and more invasive surgical procedures such as laminectomy for increasing grades of radiographic severity. LIMITATIONS: Understanding that each patient with LSS is managed on a case-by-case basis, the treatment options recommended by this algorithm should be considered "soft guidance." As such, integrated team/patient consultation is recommended to ensure maximum clinical benefit. A risk/benefit assessment and discussion should be performed with each individual patient. CONCLUSIONS: Our proposed algorithm offers an easy-to-use clinical tool and general foundation for identifying, evaluating, and treating patients with intermittent neurogenic claudication associated with LSS.

A Radiological Evaluation of Lumbar Spinous Processes and Interspinous Spaces, Including Clinical Implications.

Background and objective The aim of this study was the examination of morphometry of the spinous process (SP) and interspinous space (ISS) of the lumbar region to help provide a basis for the design and implantation of interspinous devices. Methods Between 2017 and 2019, 215 individuals underwent magnetic resonance imaging of the lumbar region for various reasons. No pathology was detected in these images, and the participants' age, height, and weight information when available were included in the study. From these images, the height and length of the SP and ISS in the lumbar region were noted. The heights of the SP and ISS were measured at three levels as anterior, middle, and posterior (respectively, anterior height of the spinous process [AHSP], middle height of the spinous process [MHSP], as well as posterior height of the spinous process [PHSP] for the height of SP, and anterior ISS, middle ISS and posterior ISS for the height of ISS). All measurements were compared according to the gender, age, weight, height, and body mass index of the individuals. Results The level with the lowest SP height and length was L5 vertebra. The ISS height and length were lowest at L4-L5. In addition, we observed a statistically significant difference at multiple levels with age, weight, height, and body mass index of the reference ranges. Conclusion We think that these changes should be considered when designing and implanting interspinous devices. Since there are few studies examining all these correlations, we think that the results of this study will make a unique contribution to the literature.

The use of minimally invasive interspinous process devices for the treatment of lumbar canal stenosis: a narrative literature review.

Minimally invasive interspinous process devices (IPD), including interspinous distraction devices (IDD) and interspinous stabilizers (ISS), are increasingly utilized for treating symptomatic lumbar canal stenosis (LCS). There is ongoing debate around their efficacy and safety over traditional decompression techniques with and without interbody fusion (IF). This study presents a comprehensive review of IPD and investigates if: (I) minimally invasive IDD can effectively substitute direct neural decompression and (II) ISS are appropriate substitutes for fusion after decompression. Articles published up to 22nd January 2020 were obtained from PubMed search. Relevant articles published in the English language were selected and critically reviewed. Observational studies across different IPD brands consistently show significant improvements in clinical outcomes and patient satisfaction at short-term follow-up. Compared to non-operative treatment, mini-open IDD was had significantly greater quality of life and clinical outcome improvements at 2-year follow-up. Compared to open decompression, mini-open IDD had similar clinical outcomes, but associated with higher complications, reoperation risks and costs. Compared to open decompression with concurrent IF, ISS had comparable clinical outcomes with reduced operative time, blood loss, length of stay and adjacent segment mobility. Mini-open IDD had better outcomes over non-operative treatment in mild-moderate LCS at 2-year follow-up, but had similar outcomes with higher risk of re-operations than open decompression. ISS with open decompression may be a suitable alternative to decompression and IF for stable grade 1 spondylolisthesis and central stenosis. To further characterize this procedure, future studies should focus on examining enhanced new generation IPD devices, longer-term follow-up and careful patient selection.

A Comprehensive Review of Novel Interventional Techniques for Chronic Pain: Spinal Stenosis and Degenerative Disc Disease-MILD Percutaneous Image Guided Lumbar Decompression, Vertiflex Interspinous Spacer, MinuteMan G3 Interspinous-Interlaminar Fusion.

Spinal stenosis is the compression of nerve roots by bone or soft tissue secondary to the narrowing of the spinal canal, lateral recesses, or intervertebral foramina. Spinal stenosis may have acquired or congenital origins. Most cases are acquired and caused by hypertrophy of the ligamentum flavum, enlarged osteophytes, degenerative arthritis, disk herniations, and various systemic illnesses. The ligamentum flavum (LF) is a highly specialized elastic ligament that connects the laminae of the spine and fuses them to the facet joint capsules. There are a number of treatment options available for spinal stenosis. Implants and surgical interventions have grown in popularity recently, and a number of these have been shown to have varying efficacy, including the minimally invasive lumbar decompression (MILD®), Vertiflex®, Coflex® Interlaminar Stabilization, and MinuteMan G3® procedures. Minimally invasive lumbar decompression (MILD®) is a minimally invasive outpatient procedure to treat spinal stenosis related to hypertrophied ligamentum flavum. The Superion® Interspinous Spacer, also known as Vertiflex®, is a titanium implant that is delivered percutaneously to relieve back pain caused by lumbar spinal stenosis. The MinuteMan® is a minimally invasive, interspinous-interlaminar fusion device planned for the temporary fixation of the thoracic, lumbar, and sacral spine, which eventually results in bony fusion. Based on our review of the available current scientific literature, the novel interventions for symptomatic lumbar spinal stenosis, such as the MILD® procedure and the Superion® interspinous spacer, generally appear to be safe and effective. There is a possibility in the future that these interventions could disrupt current treatment algorithms for lumbar spinal stenosis.

Multicenter Retrospective Review of Safety and Efficacy of a Novel Minimally Invasive Lumbar Interspinous Fusion Device.

INTRODUCTION: Several treatment options exist for those with spinal stenosis, as well as degenerative changes. This series evaluates the use of an interspinous fixation (ISF) device as performed by interventional pain physicians. METHODS: This is a retrospective analysis identifying 32 patients with the diagnosis of lumbar degenerative disc disease with secondary diagnosis of lumbar spinal stenosis being treated with ISF with Aurora Spine Zip Interspinous Spacer. Serious adverse events, specifically nerve injury, hematoma, infection, and death, were analyzed quantitatively for reported complications within 90 days from the procedure. In addition, VAS was analyzed for patient reported outcomes. RESULTS: Adverse event rate was 0% with no incidences of reoperation, or device removal. Estimated blood loss was recorded as less than 50 cc for all patients. The preoperative pain assessment demonstrated an average pain score of 8.1 and a postoperative pain score of 2.65 equating to a percentage pain reduction of 67%. CONCLUSION: This case series demonstrates the success and safety of ISF being performed by interventional pain physicians in an outpatient setting. It is a valuable tool in the treatment of moderate to severe lumbar spinal stenosis and degenerative disc disease that has decreased morbidity and significant efficacy.

Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data.

BACKGROUND: Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile. METHODS: A disproportionality analysis was conducted to determine whether a statistically significant signal exists in the three interspinous spacers and the reported adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US Food and Drug Administration. RESULTS: Statistically significant signals were found with each of the three interspinous spacer devices (Coflex, Vertiflex, and X-Stop) and each of the following adverse events: fracture, migration, and pain/worsening symptoms. CONCLUSIONS: Further studies such as randomized controlled trials are needed to validate the findings.

Comparison of Adverse Outcomes Following Placement of Superion Interspinous Spacer Device Versus Laminectomy and Laminotomy.

BACKGROUND: Current evidence suggests placement of the Superion interspinous spacer (SISS) device compared with laminectomy or laminotomy surgery offers an effective, less invasive treatment option for patients with symptomatic lumbar spinal stenosis. Both SISS placement and laminectomy or laminotomy have risks of complications and a direct comparison of complications between the 2 procedures has not been previously studied. The purpose of this study is to compare the short-term complications of the SISS with laminectomy or laminotomy and highlight device-specific long-term outcomes with SISS. METHODS: Via retrospective review, 189 patients who received lumbar level SISSs were compared with 378 matched controls who underwent primary lumbar spine laminectomy or laminotomy; data were collected from the American College of Surgeons National Surgical Quality Improvement Program database. Complications analyzed included rates of wound infection, pulmonary embolism, deep venous thrombosis, urinary tract infection, sepsis, septic shock, cardiac arrest, death, and reoperation within 30 days of index surgery. Differences between groups were analyzed using the χ2test. Device-specific complication (DSC) rates included device malfunction or misplacement (DM), device explantation (DE), spinous process fracture (SPF), and subsequent spinal surgery (SSS). RESULTS: No differences in demographics or comorbidities existed between groups. There was no significant difference in rates of complications between groups. A total of 44.4% of patients in the SISS group experienced DSCs with 11.1% of patients experiencing DM, 21.1% experiencing an SPF, 20.1% requiring DE, and 24.3% requiring SSS. Having at least 1 DSC significantly increased odds of SSS, odds ratio >120, P < .0001. CONCLUSION: Rates of 30-day complications in the SISS group were not significantly different from patients undergoing laminectomy or laminotomy. Rates of 2-year DSC within SISS and cumulative risk associated with these complications should be considered further as they likely represent need for additional procedures for patients and substantial cost to the healthcare system. LEVEL OF EVIDENCE: 4. CLINICAL RELEVANCE: Having no differences in adverse events between laminectomies or laminotomies and SISS plus evidence of substantial device-specific long-term adverse outcomes and reoperation should be given consideration when deciding on surgical intervention of 1-2 level lumbar spinal stenosis.

Lumbar disc herniation surgery: Is it worth adding interspinous spacer or instrumented fusion with regard to disc excision alone?

BACKGROUND: Discectomy is sometimes associated with recurrence of disc herniation and pain after surgery. The evidence to use an interspinous dynamic stabilization system or instrumented fusion in association with disc excision to prevent pain and re-operation remains controversial. In this study, we analyzed if adding interspinous spacer or fusion, offers advantages in relation to microdiscetomy alone. METHODS: Patients with lumbar disc herniation were divided in 3 groups; microdiscectomy alone (MD), microdiscectomy plus interspinous spacer (IS) and open discectomy plus posterior lumbar interbody fusion (PLIF). The clinical efficacy was measured using the Owestry Disability Index (ODI). Other outcome parameters including visual analogue scale for pain (VAS) back and legs, length of stay, direct in-hospital cost, 90-day complication rate, and 1-year re-operation rate were also evaluated. RESULTS: A total of 103 patients whose mean age was 39.1 (±8.5) years were included. A significant improvement of the ODI and VAS back and legs pain baseline score was detected in the 3 groups. After 1 year, no significant differences in ODI, VAS back and legs pain were found between the 3 groups. There was an increase of 169% of the total direct in- hospital cost in IS group and 287% in PLIF group, in relation to MD (p < 0.001). Length of stay was 86% higher in the IS group and 384% longer in the PLIF group compared to MD (p < 0.001). The 1 year re-operation rates were 5.6%, 10% and 16.2% (p = 0.33). Discectomy seems to be the main responsible for the clinical improvement, without the interspinous spacer or fusion adding any benefit. The addition of interspinous spacer or fusion increased direct in-hospital cost, length of stay, and did not protect against re-operation.

How I do it: step-by-step BacJac™ posterior interspinous spacer placement.

BACKGROUND: BacJac™ is a posterior interspinous spacer for selected cases of degenerative lumbar spine diseases. It blocks the metameric vertebral segment in terminal extension, restoring foraminal heights. METHODS: The authors provide a detailed step-by-step description of the surgical technique, shedding light on surgical tips and pitfalls of this procedure. An accurate pre-operative patient selection is analyzed, defining meticulously surgical indications. A high-quality video of the surgical procedure is provided. CONCLUSION: BacJac™ interspinous device allows a safe, mini-invasive, and effective treatment of selected cases of degenerative lumbar spine disease.

A Review of Lumbar Spinal Stenosis with Intermittent Neurogenic Claudication: Disease and Diagnosis.

OBJECTIVE: Lumbar spinal stenosis (LSS) is a degenerative spinal condition affecting nearly 50% of patients presenting with lower back pain. The goal of this review is to present and summarize the current data on how LSS presents in various populations, how it is diagnosed, and current therapeutic strategies. Properly understanding the prevalence, presentation, and treatment options for individuals suffering from LSS is critical to providing patients the best possible care. RESULTS: The occurrence of LSS is associated with advanced age. In elderly patients, LSS can be challenging to identify due to the wide variety of presentation subtleties and common comorbidities such as degenerative disc disease. Recent developments in imaging techniques can be useful in accurately identifying the precise location of the spinal compression. Treatment options can range from conservative to surgical, with the latter being reserved for when patients have neurological compromise or conservative measures have failed. Once warranted, there are several surgical techniques at the physician's disposal to best treat each individual case.

Interspinous Process Decompression With The Superion® Spacer For Lumbar Spinal Stenosis: Real-World Experience From A Device Registry.

BACKGROUND: Interspinous process decompression (IPD) with stand-alone spacers has demonstrated excellent long-term clinical benefit for patients with lumbar spinal stenosis (LSS). METHODS: IPD used the Superion® Indirect Decompression System (Vertiflex, Carlsbad, CA, USA). Perioperative and clinical data were captured via a registry for patients treated with IPD for LSS with intermittent neurogenic claudication. Three-hundred sixteen physicians at 86 clinical sites in the US participated. Patient data were captured from in-person interviews and a phone survey. Outcomes included intraoperative blood loss, procedural time, leg and back pain severity (100 mm VAS), patient satisfaction and treatment approval at 3 weeks, 6 and 12 months. RESULTS: The mean age of registry patients was 73.0 ± 9.1 years of which 54% were female. Mean leg pain severity decreased from 76.6 ± 22.4 mm preoperatively to 30.4 ± 34.6 mm at 12 months, reflecting an overall 60% improvement. Corresponding responder rates were 64% (484 of 751), 72% (1,097 of 1,523) and 75% (317 of 423) at 3 weeks, 6 and 12 months, respectively. Back pain severity improved from 76.8 ± 22.2 mm preoperatively to 39.9 ± 32.3 mm at 12 months (48% improvement); 12-month responder rate of 67% (297 of 441). For patient satisfaction at 3 weeks, 6 and 12 months, 89%, 80%, and 80% were satisfied or somewhat satisfied with their treatment and 90%, 75%, and 75% would definitely or probably undergo the same treatment again. In the phone survey, the rate of revision was 3.6% (51 of 1,426). CONCLUSION: These registry findings support the clinical adoption of minimally invasive IPD in patients with neurogenic claudication associated with LSS.

The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment.

BACKGROUND: Lumbar spinal stenosis (LSS) can lead to compression of neural elements and manifest as low back and leg pain. LSS has traditionally been treated with a variety of conservative (pain medications, physical therapy, epidural spinal injections) and invasive (surgical decompression) options. Recently, several minimally invasive procedures have expanded the treatment options. METHODS: The Lumbar Spinal Stenosis Consensus Group convened to evaluate the peer-reviewed literature as the basis for making minimally invasive spine treatment (MIST) recommendations. Eleven consensus points were clearly defined with evidence strength, recommendation grade, and consensus level using U.S. Preventive Services Task Force criteria. The Consensus Group also created a treatment algorithm. Literature searches yielded 9 studies (2 randomized controlled trials [RCTs]; 7 observational studies, 4 prospective and 3 retrospective) of minimally invasive spine treatments, and 1 RCT for spacers. RESULTS: The LSS treatment choice is dependent on the degree of stenosis; spinal or anatomic level; architecture of the stenosis; severity of the symptoms; failed, past, less invasive treatments; previous fusions or other open surgical approaches; and patient comorbidities. There is Level I evidence for percutaneous image-guided lumbar decompression as superior to lumbar epidural steroid injection, and 1 RCT supported spacer use in a noninferiority study comparing 2 spacer products currently available. CONCLUSIONS: MISTs should be used in a judicious and algorithmic fashion to treat LSS, based on the evidence of efficacy and safety in the peer-reviewed literature. The MIST Consensus Group recommend that these procedures be used in a multimodal fashion as part of an evidence-based decision algorithm.

Interspinous process decompression is associated with a reduction in opioid analgesia in patients with lumbar spinal stenosis.

BACKGROUND: Lumbar spinal stenosis (LSS) causes significant pain and functional impairment, and medical management has increasingly included the prescription of opioid-based analgesics. Interspinous process decompression (IPD) provides a minimally-invasive treatment option for LSS. METHODS: This study estimated the type, dosage, and duration of opioid medications through 5 years of follow-up after IPD with the Superion Indirect Decompression System (Vertiflex Inc., Carlsbad, CA USA). Data were obtained from the Superion-treatment arm of a randomized controlled noninferiority trial. The prevalence of subjects using opiates was determined at baseline through 60 months. Primary analysis included all 190 patients randomized to receive the Superion device. In a subgroup of 98 subjects, we determined opioid-medication prevalence among subjects with a history of opioid use. RESULTS: At baseline, almost 50% (94 of 190) of subjects were using opioid medication. Thereafter, there was a sharp decrease in opioid-medication prevalence from 25.2% (41 of 163) at 12 months to 13.3% (20 of 150) at 24 months to 7.5% (8 of 107) at 60 months. Between baseline and 5 years, there was an 85% decrease in the proportion of subjects using opioids. A similar pattern was also observed among subjects with a history of opiates prior to entering the trial. CONCLUSION: Stand-alone IPD is associated with a marked decrease in the need for opioid medications to manage symptoms related to LSS. In light of the current opiate epidemic, such alternatives as IPD may provide effective pain relief in patients with LSS without the need for opioid therapy.