Biphasic Calcium Phosphate Bone Graft With a Unique Surface Topography: A Single-Center Ambispective Study for Degenerative Disease of the Lumbar Spine.

Study Design: This study is an ambispective evaluation and analysis of a single-center cohort.

Objective: This study aimed to evaluate the performance of a novel biphasic calcium phosphate (BCP) bone graft with submicron-sized needle-shaped surface topography (BCP<µm) in interbody arthrodesis of the lumbar spine.

Methods: This study was a single-center ambispective assessment of adult patients receiving BCP<µm as part of their lumbar interbody fusion surgery.

Finite element analysis comparing a PEEK posterior fixation device versus pedicle screws for lumbar fusion.

Background: Pedicle screw loosening and breakage are common causes of revision surgery after lumbar fusion. Thus, there remains a continued need for supplemental fixation options that offer immediate stability without the associated failure modes. This finite element analysis compared the biomechanical properties of a novel cortico-pedicular posterior fixation (CPPF) device with those of a conventional pedicle screw system (PSS).

Cervical Disc Arthroplasty vs Anterior Cervical Discectomy and Fusion at 10 Years: Results From a Prospective, Randomized Clinical Trial at 3 Sites.

Background: Over the past 20 years, multiple randomized controlled trials have shown cervical disc arthroplasty (CDA) to be safe and effective for treating 1- and 2-level degenerative disc disease (DDD). The purpose of this postmarket study is to compare 10-year outcomes between CDA and anterior cervical discectomy and fusion (ACDF) from a randomized study at 3 centers.

Methods: This study was a continuation of a randomized, prospective, multicenter clinical trial comparing CDA with the Mobi-C cervical disc (Zimmer Biomet) vs ACDF.

Metal-Free Cortico-Pedicular Device for Supplemental Fixation in Lumbar Interbody Fusion.

Objective: Pedicle screw fixation is a commonly utilized adjunct for lumbar interbody fusion, yet risks include screw malposition, pullout, loosening, neurovascular injury, and stress transfers leading to adjacent segment degeneration. This report describes the preclinical and initial clinical results of a minimally invasive, metal-free cortico-pedicular fixation device used for supplemental posterior fixation in lumbar interbody fusion.

Methods: Safety of arcuate tunnel creation was evaluated in cadaveric lumbar (L1-S1) specimens.

Two-Year Outcomes From a Prospective Multicenter Investigation Device Trial of a Novel Conformal Mesh Interbody Fusion Device.

Background: Interbody fusion is a widely utilized and accepted procedure to treat advanced debilitating lumbar degenerative disc disease (DDD). Increasingly, surgeons are seeking interbody devices that are large for stability and grafting purposes but can be inserted with less invasive techniques. To achieve these contrary objectives a novel, conformable mesh interbody fusion device was designed to be placed in the disc space through a small portal and filled with bone graft in situ to a large size.

Cervical Total Disc Replacement: Indications and Technique.

Cervical total disc replacement devices have been marketed in the United States (US) since 2007, with abundant level 1 evidence published on the treatment. Adherence to the strict inclusion/exclusion criteria and the surgical technique training of the US clinical trials remains the consistent and conservative approach to patient selection and implantation technique. However, patient selection and surgical technique remain debated among US surgeons as the published data and available cervical total disc replacements continue to grow.

Spontaneous regression and near disappearance of a calcified herniated thoracic disc in a 44-year-old male: illustrative case.

Background: Herniation of an intervertebral disc (IVD) is found predominantly in the lumbar and cervical spine of both children and adults, but herniated IVDs of the thoracic spine are a rare occurrence. However, approximately 40% of herniated thoracic disc cases are calcified. Approximately 0.

Load Share Mapping for Traditional PEEK vs Novel Hybrid PEEK With Expandable Porous Mesh Intervertebral Devices.

Background: A successful intervertebral fusion requires biomechanical stability created by the structural support of the interbody device and loading of the bone graft material to accelerate mechanotransduction and bone remodeling. The objective of this study was to generate a quantitative map of the contact area and stress profile for 2 implant designs; a rigid monolithic polyetheretherketone (PEEK) lateral cage (MPLC), and a unique hybrid interbody design, which includes PEEK terminal supports surrounding an expandable porous mesh (P+EPM) that serves to contain bone graft.

Methods: The construct for each test consisted of a device sandwiched between 2 flat or shaped Grade 15 foam blocks.

Cell and Tissue Response to Polyethylene Terephthalate Mesh Containing Bone Allograft in Vitro and in Vivo.

Background: Extended polyethylene terephthalate mesh (PET, Dacron) can provide containment of compressed particulate allograft and autograft. This study assessed if PET mesh would interfere with osteoprogenitor cell migration from vertebral plates through particulate graft, and its effect on osteoblast differentiation or the quality of bone forming within fusing vertebra during vertebral interbody fusion.

Methods: The impact of PET mesh on the biological response of normal human osteoblasts (NHOst cells) and bone marrow stromal cells (MSCs) to particulate bone graft was examined in vitro.

Critical Evaluation of Biomechanical Principles and Radiographic Indicators for Fusion Assessment in a Novel Conformable Porous Mesh Implant.

Introduction: The objectives of this paper were to identify and explain specific design factors for lumbar interbody fusion (IBF) devices that can influence bone exchange and stability at the vertebral endplate interface and to provide supporting evidence of these factors through both laboratory and clinical data. The laboratory study (Part 1) compared the pressure profiles and contact areas for a minimally invasive, expandable, and conformable porous mesh (CPM) IBF device and a rigid monolithic lateral PEEK cage (LPC). Furthermore, to demonstrate how these laboratory results translate clinically, a quantitative and qualitative assessment of subject x-rays and computed tomography (CT) scans from a US Food and Drug Administration (FDA) investigational device exemption (IDE) trial of the CPM was performed (Part 2).

Patient Selection in Cervical Disc Arthroplasty.

Background: Patient selection for cervical disc arthroplasty (CDA) in the United States remains a topic of debate among surgeons. Many surgeons base US patient selection for CDA implantation on the Food and Drug Administration (FDA) indications/contraindications. While off-label use does occur, the frequency and extent of off-label use in the US remains largely unknown.

One Year Outcomes From a Prospective Multicenter Investigation Device Trial of a Novel Conformal Mesh Interbody Fusion Device.

Study Design: A prospective multicenter investigational device exempt trial is underway evaluating a novel conformable mesh interbody fusion device in subjects undergoing single-level fusion for degenerative disc disease. Patients meeting inclusion and exclusion criteria were offered enrollment. There is no comparative group in this study.

PEEK versus titanium cages in lateral lumbar interbody fusion: a comparative analysis of subsidence.

Objective: The authors have provided a review of radiographic subsidence after lateral lumbar interbody fusion (LLIF) as a comparative analysis between titanium and polyetheretherketone (PEEK) cages. Many authors describe a reluctance to use titanium cages in spinal fusion secondary to subsidence concerns due to the increased modulus of elasticity of metal cages. The authors intend for this report to provide observational data regarding the juxtaposition of these two materials in the LLIF domain.

Adjacent Segment Pathology After Treatment With Cervical Disc Arthroplasty or Anterior Cervical Discectomy and Fusion, Part 2: Clinical Results at 7-Year Follow-Up.

Background: Adjacent segment pathology (ASP) following cervical disc arthroplasty (CDA) or anterior cervical discectomy and fusion (ACDF) is identified by imaging (RASP) or clinical symptoms (CASP). Clinical symptoms of CASP have been broadly defined, but subsequent adjacent-level surgeries are clear indicators of CASP. Current literature remains inconsistent in the incidence and potential predictors of CASP.

Adjacent Segment Pathology After Treatment With Cervical Disc Arthroplasty or Anterior Cervical Discectomy and Fusion, Part 1: Radiographic Results at 7-Year Follow-Up.

Background: Adjacent segment pathology (ASP) remains a concern following treatment with cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF). Radiographic ASP (RASP) is ASP identified on imaging, which may or may not include clinical symptoms. The risk factors for development of RASP and its clinical effects remain controversial.

Heterotopic Ossification After Cervical Total Disc Replacement at 7 Years-Prevalence, Progression, Clinical Implications, and Risk Factors.

Background: Heterotopic ossification (HO) is a known risk following cervical total disc replacement (CTDR) surgery, but the cause and effect of HO are not well understood. Reported HO rates vary, and few studies are specifically designed to report HO. The effects on outcomes, and the risk factors for the development of HO have been hypothesized and reported in small-population, retrospective analyses, using univariate statistics.

Cervical Disc Arthroplasty: Current Evidence and Real-World Application.

Cervical total disc replacement (cTDR) is still considered a developing technology, with widespread clinical use beginning in the early 2000s. Despite being relatively new to the marketplace, the literature surrounding cTDR is abundant. We conducted a thorough review of literature published in the United States (US) and outside the US to report the current global state of cTDR research and clinical use.

Short-term outcomes of lateral lumbar interbody fusion without decompression for the treatment of symptomatic degenerative spondylolisthesis at L4-5.

OBJECTIVE Recently, authors have called into question the utility and complication index of the lateral lumbar interbody fusion procedure at the L4-5 level. Furthermore, the need for direct decompression has also been debated. Here, the authors report the clinical and radiographic outcomes of transpsoas lumbar interbody fusion, relying only on indirect decompression to treat patients with neurogenic claudication secondary to Grade 1 and 2 spondylolisthesis at the L4-5 level.

Impact of case type, length of stay, institution type, and comorbidities on Medicare diagnosis-related group reimbursement for adult spinal deformity surgery.

OBJECTIVE The aim of this study was to educate medical professionals about potential financial impacts of improper diagnosis-related group (DRG) coding in adult spinal deformity (ASD) surgery. METHODS Medicare's Inpatient Prospective Payment System PC Pricer database was used to collect 2015 reimbursement data for ASD procedures from 12 hospitals. Case type, hospital type/location, number of operative levels, proper coding, length of stay, and complications/comorbidities (CCs) were analyzed for effects on reimbursement.

Neurological Complications after Lateral Transpsoas Approach to Anterior Interbody Fusion with a Novel Flat-Blade Spine-Fixed Retractor.

Introduction. The lateral lumbar interbody fusion (LLIF) surgical approach has potential advantages over other approaches but is associated with some unique neurologic risks due to the proximity of the lumbosacral plexus. The present study analyzed complications following LLIF surgical approach using a novel single flat-blade retractor system.

Preliminary Results of Bioactive Amniotic Suspension with Allograft for Achieving One and Two-Level Lumbar Interbody Fusion.

Background: Bone graft material for lumbar fusion was historically autologous bone graft (ABG). In recent years alternatives such as allograft, demineralized bone matrix (DBM), ceramics, and bone morphogenetic protein (BMP) have gained favor, although the complications of these are not fully understood. Bioactive amniotic suspension (BAS) with allograft is a new class of material derived from human amniotic tissue.

Cost Utility Analysis of the Cervical Artificial Disc vs Fusion for the Treatment of 2-Level Symptomatic Degenerative Disc Disease: 5-Year Follow-up.

Background: The cervical total disc replacement (cTDR) was developed to treat cervical degenerative disc disease while preserving motion.

Objective: Cost-effectiveness of this intervention was established by looking at 2-year follow-up, and this update reevaluates our analysis over 5 years.

Methods: Data were derived from a randomized trial of 330 patients.

Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results.

Object: The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up.

Methods: A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the U.S.

Cost-effectiveness of cervical total disc replacement vs fusion for the treatment of 2-level symptomatic degenerative disc disease.

Importance: Cervical total disc replacement (CTDR) was developed to treat cervical spondylosis, while preserving motion. While anterior cervical discectomy and fusion (ACDF) has been the standard of care for 2-level disease, a randomized clinical trial (RCT) suggested similar outcomes. Cost-effectiveness of this intervention has never been elucidated.