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Publications (113)
This study investigates the use of magnetic resonance spectroscopy (MRS) to identify the intervertebral disc (IVD) as a pain generator, explore the pathophysiology of the biochemical and structural components of discogenic low back pain (DLBP), and present potential evidence of physiological responses to spinal manipulation therapy (SMT). A 29-year...
Purpose
MRS was shown to reliably quantify relative levels of degenerative pain biomarkers, differentiating painful versus non-painful discs in patients with chronic discogenic low back pain (DLBP), and this correlates with surgical success rates. We now report results based on more patients and longer follow-up.
Methods
Disc MRS was performed in...
INTRODUCTION: We report utility of magnetic resonance spectroscopy (MRS) in identifying the intervertebral disc (IVD) as a pain generator, describe the contemporary pathophysiology underlying biochemical and structural components of discogenic low back pain (DLBP), and exhibit therapeutic responses to spinal manipulation.
CLINICAL FEATURES: A 29-ye...
The full text of this preprint has been withdrawn by the authors as it was submitted and made public without the full consent of all the authors. Therefore, the authors do not wish this work to be cited as a reference. Questions should be directed to the corresponding author.
BACKGROUND CONTEXT
Allogeneic disc progenitor cells derived from adult intervertebral disc tissue have demonstrated both immunomodulatory and regenerative properties in preclinical animal studies. This includes the ability to increase aggrecan and collagen production and restore disc histology. These cells have the potential to impact the pathophys...
BACKGROUND CONTEXT
Lumbar disc arthroplasty (LDA) for discogenic back pain has been shown to be safe and effective. However, there is continued hesitancy to surgically treat patients receiving workers' compensation based on widespread belief that they may show restricted benefit from surgical treatments.
PURPOSE
This study reviewed outcomes to eva...
Background:
Driving an automobile requires the ability to turn the neck laterally. Anecdotally, patients with multilevel fusions often complain about restricted turning motion. The purpose of this study was to compare the effectiveness of cervical disc arthroplasty (CDA) with anterior cervical discectomy and fusion (ACDF) on driving disability imp...
Background:
Cervical disc arthroplasty (CDA) is an established treatment for degenerative disc disease with radiculopathy and/or myelopathy. There is, however, little published evidence of its effectiveness to relieve pain and improve function in patients with a primary diagnosis of axial neck pain. Such patients were excluded from all previous Fo...
Study design:
This was a post hoc analysis of a prospective FDA-IDE study.
Objective:
The purpose of this study is to determine the effectiveness of a 2-level anterior cervical discectomy and fusion (ACDF) or cervical disk arthroplasty (CDA) at relieving headaches associated with cervical radiculopathy or myelopathy at 10 years postoperative.
B...
BACKGROUND CONTEXT
Cervical disc arthroplasty (CDA) is a proven, effective treatment for degenerative disc disease with radiculopathy and/or myelopathy. There is, however, little published evidence of the effectiveness of CDA in relieving pain and improving function in patients with a primary diagnosis of axial neck pain.
PURPOSE
This study compar...
BACKGROUND CONTEXT
Evaluation of 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) using the Prestige LP™ disc to treat degenerative cervical spine disease at two adjacent levels has been completed and published. One of the contributing factors to the current opioid crisis in the U. is increased opioid prescription for b...
BACKGROUND CONTEXT
Evaluation of 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) using the Prestige LP™ disc to treat degenerative cervical spine disease at two adjacent levels has been completed. Occurrence of heterotopic ossification (HO) surrounding the prosthesis following CDA has been reported for other prostheses...
Background:
Multilevel cervical degenerative disc disease in 2 or more segments poses treatment challenges. Anterior cervical discectomy and fusion is a viable treatment option, but one with high rates of adjacent segment disease and pseudoarthrosis. Cervical disc arthroplasty (CDA) is approved by the US Food and Drug Administration for the treatm...
Objective:
The authors sought to assess the impact of heterotopic ossification (HO) on clinical outcomes and angular range of motion (ROM) after cervical disc arthroplasty (CDA) performed with the Prestige LP Cervical Disc (Prestige LP disc) at 2 levels.
Methods:
HO was assessed and graded from 0 to IV for increasing severity on lateral neutral...
Background:
Anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) have been used to treat degenerative disc disease at single as well as multiple cervical levels. This study compares the safety and efficacy of 1-level versus 2-level CDA and ACDF.
Methods:
In total, 545 and 397 patients with degenerative disc disease...
BACKGROUND CONTEXT
Interspinous process distraction (IPD) devices aim to alleviate back and leg pain by limiting extension and unloading the 3-joint complex at the affected lumbar level. IPDs may offer a treatment option for painful degenerative disc disease (DDD) that is not yet indicated for fusion or disc replacement.
PURPOSE
To compare the saf...
Objective:
The authors assessed the 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) to treat degenerative cervical spine disease at 2 adjacent levels compared to anterior cervical discectomy and fusion (ACDF).
Methods:
A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted compa...
OBJECTIVE
Food and Drug Administration–approved investigational device exemption (IDE) studies have provided level I evidence supporting cervical disc arthroplasty (CDA) as a safe and effective alternative to anterior cervical discectomy and fusion (ACDF). Long-term CDA outcomes continue to be evaluated. Here, the authors present outcomes at 10 yea...
OBJECTIVE
Despite evidence of its safety and effectiveness, the use of lumbar disc arthroplasty has been slow to expand due in part to concerns about late complications and the risks of revision surgery associated with early devices. More recently, FDA approval of newer devices and improving reimbursements have reversed this trend in the United Sta...
Study design:
Analysis of 2- and 7-year outcomes from a clinical trial comparing 2-level cervical disk arthroplasty (CDA) to anterior cervical discectomy and fusion (ACDF) in 287 patients with radiculopathy alone, and 110 patients with myelopathy alone or myelopathy with radiculopathy.
Objective:
To compare the long-term safety and effectiveness...
Background:
Outpatient surgery has been shown safe and effective for anterior cervical discectomy and fusion (ACDF), and more recently, for 1-level cervical disc arthroplasty (CDA). The purpose of this analysis is to compare the safety and efficiency of 1-level and 2-level CDA performed in an ambulatory surgery center (ASC) and in a hospital setti...
BACKGROUND CONTEXT
Cervical disc arthroplasty (CDA) is FDA-approved for the treatment of 1- and 2-level cervical disc disease. The long-term safety and efficacy of CDA at one or two levels is supported by extensive Level I evidence. However, little research evidence exists for CDA performed at more than two levels. To our knowledge, this is the lar...
BACKGROUND CONTEXT
Level I evidence from FDA IDE studies of multiple devices supports cervical disc arthroplasty (CDA) as a safe and effective alternative to anterior cervical discectomy and fusion for appropriately selected patients. Long-term outcomes following CDA continue to be assessed.
PURPOSE
This reports the 10-year postoperative outcomes...
BACKGROUND CONTEXT
We previously showed that MRS+/− determinations of relative discogenic pain chemical biomarker levels correlates with provocative discography results (PD+/−) for painful (P) versus nonpainful (NP) discs in chronic, severe DLBP patients.
PURPOSE
This current study extends our previous work, and further evaluates if MRS+/− disc da...
Supplemental Material, activL_5-year_Meta-analysis_Manuscript-Supplemental-Mar_9_2017 - Comparison of Lumbar Total Disc Replacement With Surgical Spinal Fusion for the Treatment of Single-Level Degenerative Disc Disease: A Meta-Analysis of 5-Year Outcomes From Randomized Controlled Trials
Background context:
Health-related quality-of-life outcomes have been collected with the Medical Outcomes Study (MOS) Short Form 36 (SF-36) survey. Boston University School of Public Health has developed algorithms for the conversion of SF-36 to VR-12 physical component summary (PCS) and mental component summary (MCS).
Purpose:
The purpose of th...
: This publication focuses on proceedings from the First Annual Lumbar Total Disc Replacement Summit, held October 25, 2016 in Boston, MA. The Summit brought together 17 thought leading surgeons who employed a modified-Delphi method to determine where consensus existed pertaining to the utilization of lumbar total disc replacement as a standard of...
: Lumbar total disc replacement, now in use since 2004, was determined by the panel to be a standard of care for the treatment of symptomatic single-level lumbar degenerative disc disease in the active patient subpopulation as outlined by the investigational device exemption study criteria. The large body of evidence supporting this statement, incl...
Study Design
Meta-analysis.
Objectives
To evaluate the long-term efficacy and safety of total disc replacement (TDR) compared with fusion in patients with functionally disabling chronic low back pain due to single-level lumbar degenerative disc disease (DDD) at 5 years.
Methods
PubMed and Cochrane Central Register of Controlled Trials databases w...
INTRODUCTION
Cervical disc arthroplasty (CDA) is an effective treatment for symptomatic cervical disc disease (SCDD). Concerns remain about the appropriateness of CDA to treat patients with myelopathy. This study compares long-term safety and effectiveness of CDA in patients with myelopathy versus radiculopathy.
METHODS
Retrospective analysis of p...
OBJECTIVE
The aim of this study was to assess long-term clinical safety and effectiveness in patients undergoing anterior cervical surgery using the Prestige LP artificial disc replacement (ADR) prosthesis to treat degenerative cervical spine disease at 2 adjacent levels compared with anterior cervical discectomy and fusion (ACDF).
METHODS
A prosp...
OBJECTIVE
The authors compared the efficacy and safety of arthroplasty using the Prestige LP cervical disc with those of anterior cervical discectomy and fusion (ACDF) for the treatment of degenerative disc disease (DDD) at 2 adjacent levels.
METHODS
Patients from 30 investigational sites were randomized to 1 of 2 groups: investigational patients...
Background:
Cervical disc arthroplasty (CDA) has emerged as an alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of cervical pathologies. Studies are on-going to assess the long term outcomes of CDA. This study assessed the safety and efficacy of the Prestige(®) LP Disc at 84-months follow up.
Methods:
Prospective d...
Study design:
Prospective longitudinal study.
Objective:
The serum titanium (Ti) concentrations were examined in patients implanted with a PRESTIGE LP™ Cervical Disc System (Medtronic, Inc., Memphis, TN). The metal-on-metal disc with ball-in-trough articulation is made of titanium alloy/titanium carbide composite (Ti-6Al-4 V/TiC).
Summary of ba...
Background:
Depression has been associated with inferior outcomes following lumbar spine surgery. Our purpose was to investigate the prevalence of depression and its impact on the outcomes of a large sample of cervical disc arthroplasty patients and to examine the change in depression occurring in conjunction with changes in disability and pain....
Background
Receiving Workers’ Compensation benefits has been associated with inferior outcomes after lumbar fusion. The purpose of our study was to compare the outcomes of cervical disc arthroplasty between patients receiving and those not receiving Workers’ Compensation.
Methods
Patient-reported outcomes, reoperations, complications, and return-t...
OBJECT
This study compared the safety and efficacy of treatment with the PRESTIGE LP cervical disc versus a historical control anterior cervical discectomy and fusion (ACDF).
METHODS
Prospectively collected PRESTIGE LP data from 20 investigational sites were compared with data from 265 historical control ACDF patients in the initial PRESTIGE Cervi...
This study aimed at determining the variables that may prove useful in predicting clinical outcomes following lumbar disc arthroplasty.
Pre- and post-operative imaging assessments were obtained for 99 single-level lumbar disc arthroplasty patients from a prospective IDE study. The assessments and patient demographics were tested to identify variabl...
Purpose
Metal-on-metal total disc replacement is a recent alternative treatment for degenerative disc disease. Wear and corrosion of these implants can lead to local and systemic transport of metal debris. This prospective longitudinal study examined the serum chromium and cobalt levels in 24 patients with cobalt–chromium alloy metal-on-metal lumba...
To investigate an outbreak of bacterial meningitis at an outpatient radiology clinic (clinic A) and to determine the source and implement measures to prevent additional infections.
A case was defined as bacterial meningitis in a patient undergoing myelography at clinic A from October 11 to 25, 2010. Patients who underwent myelography and other proc...
The concept of semi-rigid fixation (SRF) has driven the development of spinal implants that utilize nonmetallic materials and novel rod geometries in an effort to promote fusion via a balance of stability, intra- and inter-level load sharing, and durability. The purpose of this study was to characterize the mechanical and biomechanical properties o...
Randomized, controlled, multicenter, investigational device exemption trial.
To investigate the safety and effectiveness of the first two-piece, metal-on-metal lumbar disc prosthesis for treating patients with single-level degenerative disc disease.
For patients with degenerative disc disease unresponsive to conservative measures, lumbar disc arthr...
Prospective, longitudinal cohort study.
To examine the incidence of bone morphogenetic protein (BMP)-2 antibody formation in lumbar spine applications and to determine the clinical significance of an antibody response.
Immune responses can affect the safety and efficacy profile of recombinant proteins. Type, incidence, and time course of antibody f...
Computed tomography (CT) scan has been shown to be more accurate than radiographs in evaluating anterior interbody fusion but may still over-read the extent of fusion.
To assess the reliability and accuracy of fine-cut CT scans with reconstructions in evaluating anterior lumbar interbody fusion (ALIF) with metallic cages using surgical exploration...
A retrospective review of prospectively collected data.
To review systematically the SF-36 PCS outcomes of a large data set, including several randomized clinical trials for lumbar spine fusion at 1 and 2 years after surgery. We also present for comparison a review of typical changes in SF-36 PCS in other surgical interventions (total knee replacem...
A prospective, nonblinded, multicenter study.
To determine the patterns of allograft incorporation and new bone formation after ALIF using stand-alone threaded cortical allograft dowels with either autograft or rhBMP-2.
Accelerated healing patterns of allograft dowels have been reported in an animal study and a small human study of ALIF with rhBMP-...
Patient-based quality of life scales have become a critical element of post-op assessment for lumbar fusion surgery. The most extensive outcomes data have been generated through FDA-regulated IDE trials for new technologies, which produce excellent data but are constrained by strict enrollment criteria and limited indications. This raises a questio...
To determine whether preoperative disc space height (DSH) influences the clinical outcomes of patients diagnosed with single-level symptomatic discogenic disease and treated with a stand-alone anterior lumbar interbody fusion with two tapered threaded fusion cages, we performed a retrospective analysis of 392 patients.
Preoperative radiographs were...
Operative techniques for fusing an unstable por- tion of the lumbar spine or immobilizing a painful vertebral motion segment have been in use for many years. Lumbar fusion procedures initially were used to treat patients with infections (tuberculous spondy- litis) or misaligned spines (isthmic spondylolisthesis) (1-8). Early techniques involving th...
Recombinant human bone morphogenetic protein-2 soaked into an absorbable collagen sponge (rhBMP-2/ACS) has been shown in a nonhuman primate study and in a pilot study in humans to promote new bone formation and incorporation of an allograft device when implanted in patients undergoing anterior lumbar interbody arthrodesis. However, a larger series...