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.

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.

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.

Pedicle Screw-Associated Violation of the Adjacent Unfused Facet Joint: Clinical Outcomes and Fusion Rates.

Study Design: Retrospective review of a prospective randomized trial.

Objectives: To compare outcome scores and fusion rates in patients with and without pedicle screw-associated facet joint violation (FJV) after a single-level lumbar fusion.

Methods: Clinical outcomes data and computed tomography (CT) imaging were reviewed for 157 patients participating in a multicenter prospective trial.

Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction.

Background: Restorative neurostimulation is a rehabilitative treatment for patients with refractory chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle resulting in impaired neuromuscular control. The ReActiv8-B randomized, sham-controlled trial provided evidence of the effectiveness and safety of an implanted, restorative neurostimulator. The two-year analysis previously published in this journal demonstrated accrual of clinical benefits and long-term durability.

An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial.

Chronic low back pain can be caused by impaired control and degeneration of the multifidus muscles and consequent functional instability of the lumbar spine. Available treatment options have limited effectiveness and prognosis is unfavorable. We conducted an international randomized, double-blind, sham-controlled trial at 26 multidisciplinary centers to determine safety and efficacy of an implantable, restorative neurostimulator designed to restore multifidus neuromuscular control and facilitate relief of symptoms (clinicaltrials.

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-β, 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-β, 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-β + BMP-4, or chitosan + TGF-β + BMP-4 + TIMP-2.

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).

Comparing rates of early pedicle screw loosening in posterolateral lumbar fusion with and without transforaminal lumbar interbody fusion.

Background Context: Addition of interbody fusion via a transforaminal approach (TLIF) has become a popular surgical option for treatment of degenerative lumbar conditions. Although technically more complicated than posterolateral fusion surgery (PLF), it has been suggested that TLIF provides superior immediate stability and protects against early pedicle screw loosening. This theory has never been formally examined in a clinical study.

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

Unlabelled: 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.

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.

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.

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.

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.