Vertebral body stenting: a new method for vertebral augmentation versus kyphoplasty

Vertebroplasty and kyphoplasty are well-established minimally invasive treatment options for compression fractures of osteoporotic vertebral bodies. Possible procedural disadvantages, however, include incomplete fracture reduction or a significant loss of reduction after balloon tamp deflation, prior to cement injection. A new procedure called “vertebral body stenting” (VBS) was tested in vitro and compared to kyphoplasty. VBS uses a specially designed catheter-mounted stent which can be implanted and expanded inside the vertebral body. As much as 24 fresh frozen human cadaveric vertebral bodies (T11-L5) were utilized. After creating typical compression fractures, the vertebral bodies were reduced by kyphoplasty (n = 12) or by VBS (n = 12) and then stabilized with PMMA bone cement. Each step of the procedure was performed under fluoroscopic control and analysed quantitatively. Finally, static and dynamic biomechanical tests were performed. A complete initial reduction of the fractured vertebral body height was achieved by both systems. There was a significant loss of reduction after balloon deflation in kyphoplasty compared to VBS, and a significant total height gain by VBS (mean ± SD in %, p < 0.05, demonstrated by: anterior height loss after deflation in relation to preoperative height [kyphoplasty: 11.7 ± 6.2; VBS: 3.7 ± 3.8], and total anterior height gain [kyphoplasty: 8.0 ± 9.4; VBS: 13.3 ± 7.6]). Biomechanical tests showed no significant stiffness and failure load differences between systems. VBS is an innovative technique which allows for the possibly complete reduction of vertebral compression fractures and helps maintain the restored height by means of a stent. The height loss after balloon deflation is significantly decreased by using VBS compared to kyphoplasty, thus offering a new promising option for vertebral augmentation

Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction

Background: Adults with refractory, mechanical chronic low back pain associated with impaired neuromuscular control of the lumbar multifidus muscle have few treatment options that provide long-term clinical benefit. This study hypothesized that restorative neurostimulation, a rehabilitative treatment that activates the lumbar multifidus muscles to overcome underlying dysfunction, is safe and provides relevant and durable clinical benefit to patients with this specific etiology. Materials and Methods: In this prospective five-year longitudinal follow-up of the ReActiv8-B pivotal trial, participants (N = 204) had activity-limiting, moderate-to-severe, refractory, mechanical chronic low back pain, a positive prone instability test result indicating impaired multifidus muscle control, and no indications for spine surgery. Low back pain intensity (10-cm visual analog scale [VAS]), disability (Oswestry Disability Index), and quality of life (EuroQol's “EQ-5D-5L” index) were compared with baseline and following the intent-to-treat principle, with a supporting mixed-effects model for repeated measures that accounted for missing data. Results: At five years (n = 126), low back pain VAS had improved from 7.3 to 2.4 cm (−4.9; 95% CI, −5.3 to −4.5 cm; p &lt; 0.0001), and 71.8% of participants had a reduction of ≥50%. The Oswestry Disability Index improved from 39.1 to 16.5 (−22.7; 95% CI, −25.4 to −20.8; p &lt; 0.0001), and 61.1% of participants had reduction of ≥20 points. The EQ-5D-5L index improved from 0.585 to 0.807 (0.231; 95% CI, 0.195–0.267; p &lt; 0.0001). Although the mixed-effects model attenuated completed-case results, conclusions and statistical significance were maintained. Of 52 subjects who were on opioids at baseline and had a five-year visit, 46% discontinued, and 23% decreased intake. The safety profile compared favorably with neurostimulator treatments for other types of back pain. No lead migrations were observed. Conclusion: Over a five-year period, restorative neurostimulation provided clinically substantial and durable benefits with a favorable safety profile in patients with refractory chronic low back pain associated with multifidus muscle dysfunction. Clinical Trial Registration: The Clinicaltrials.gov registration number for the study is NCT02577354; registration date: October 15, 2016; principal investigator: Christopher Gilligan, MD, Brigham and Women's Hospital, Boston, MA, USA. The study was conducted in Australia (Broadmeadow, New South Wales; Noosa Heads, Queensland; Welland, South Australia; Clayton, Victoria), Belgium (Sint-Niklaas; Wilrijk), The Netherlands (Rotterdam), UK (Leeds, London, Middlesbrough), and USA (La Jolla, CA; Santa Monica, CA; Aurora, CO; Carmel, IN; Indianapolis, IN; Kansas City, KS; Boston, MA; Royal Oak, MI; Durham, NC; Winston-Salem, NC; Cleveland, OH; Providence, RI; Spartanburg, SC; Spokane, WA; Charleston, WV).</p

Allograft Cellular Bone Matrix in Extreme Lateral Interbody Fusion: Preliminary Radiographic and Clinical Outcomes

Introduction. Extreme lateral interbody fusion (XLIF) is a minimally disruptive alternative for anterior lumbar interbody fusion. Recently, synthetic and allograft materials have been increasingly used to eliminate donor-site pain and complications secondary to autogenous bone graft harvesting. The clinical use of allograft cellular bone graft has potential advantages over autograft by eliminating the need to harvest autograft while mimicking autograft's biologic function. The objective of this study was to examine 12-month radiographic and clinical outcomes in patients who underwent XLIF with Osteocel Plus, one such allograft cellular bone matrix. Methods. Forty (40) patients were treated at 61 levels with XLIF and Osteocel Plus and included in the analysis. Results. No complications were observed. From preoperative to 12-month postoperative followup, ODI improved 41%, LBP improved 55%, leg pain improved 43.3%, and QOL (SF-36) improved 56%. At 12 months, 92% reported being “very” or “somewhat” satisfied with their outcome and 86% being either “very” or “somewhat likely” to choose to undergo the procedure again. Complete fusion was observed in 90.2% (55/61) of XLIF levels. Conclusions. Complete interbody fusion with Osteocel Plus was shown in 90.2% of XLIF levels, with the remaining 9.8% being partially consolidated and progressing towards fusion at 12 months

Short-segment minimally disruptive anterior column release for focal sagittal deformity correction of the thoracolumbar spine

Background: Sagittal malalignment is associated with poor quality of life. Correction of lumbar lordosis through anterior column release (ACR) has been shown to improve overall sagittal alignment, however typically in combination with long posterior constructs and associated morbidity. The technical feasibility and radiographic outcomes of short-segment anterior or lateral minimally invasive surgery (MIS) ACR techniques in moderate to severe lumbar sagittal deformity were evaluated. Methods: Consecutive patients treated with short-segment MIS ACR techniques for moderate to severe lumbar sagittal deformity correction were retrospectively analyzed from a prospectively collected database. Clinical outcomes included perioperative measures of invasiveness, including operative time, blood loss, complications, and average length of stay. Radiographic outcomes included measurement of preoperative, immediate postoperative, and long-term follow-up radiographic parameters including coronal Cobb angle, lumbar lordosis (LL), pelvic incidence (PI), PI-LL mismatch, pelvic tilt (PT), T1 pelvic angle (TPA), T1 spino-pelvic inclination (T1SPI), proximal junctional angle (PJA), and sagittal vertical axis (SVA). Results: The cohort included 34 patients (mean age 63) who were treated at an average 2.5 interbody levels (range 1-4) through a lateral or anterior approach (LLIF or ALIF). Of 89 total interbody levels treated, 63 (71%) were ACR levels. Posterior fixation was across an average of 3.2 levels (range 1-5). Mean total operative time and blood loss were 362 minutes and 621 mL. Surgical complications occurred in 2 (5.9%). Average hospital stay was 5.5 days (including staging). At last follow-up (average 25.4 months; range 0.5-7 years), all patients (100%) demonstrated successful achievement of one or more alignment goal, with significant improvements in coronal Cobb, LL, PI-LL mismatch, PT, and TPA. No patient was revised for PJK. Conclusions: These data show that short-segment MIS ACR correction of moderate to severe lumbar sagittal deformity is feasible and effective at achieving overall alignment goals with low procedural morbidity and risk of proximal junctional issues