Intervertebral Disc Magnetic Resonance Spectroscopy Changes After Spinal Manipulative Therapy for Lumbar Discogenic Pain.

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-old male presented with uncomplicated low back pain (LBP). The non-specific presentation and clinical examination findings were consistent with an initial working diagnosis of non-specific LBP with the clinician suspecting IVD as a likely pain generator.

Allogeneic Disc Progenitor Cells Safely Increase Disc Volume and Improve Pain, Disability, and Quality of Life in Patients With Lumbar Disc Degeneration-Results of an FDA-Approved Biologic Therapy Randomized Clinical Trial.

Background: Progenitor cells derived from intervertebral disc tissue demonstrated immunomodulatory and regenerative properties in preclinical studies. We report the safety and efficacy results of a US Food and Drug Administration-approved clinical trial of these cells for the treatment of symptomatic degenerative disc disease.

Methods: Sixty patients with symptomatic single-level lumbar degenerative disc disease (mean age 37.

Cervical Disc Arthroplasty for Axial Neck Pain: Comparison of Outcomes to 2 Other Common Cervical Conditions.

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 Food and Drug Administration clinical trials for CDA.

Multilevel Cervical Disc Arthroplasty: Long-Term Outcomes at 3 and 4 Levels.

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 treatment of 1- and 2-level cervical pathology, with established long-term safety and effectiveness.

Occurrence and clinical implications of heterotopic ossification after cervical disc arthroplasty with the Prestige LP Cervical Disc at 2 contiguous levels.

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 radiographs at each visit in 209 patients who underwent implantation of Prestige LP discs at 2 cervical levels in a clinical trial with extended 10-year follow-up. ROM was compared by using HO grade, and clinical outcomes were compared between HO subgroups (grade 0-II vs III/IV) based on HO severity at 2 and 10 years after surgery.

One-Level Versus 2-Level Treatment With Cervical Disc Arthroplasty or Fusion: Outcomes Up to 7 Years.

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 were studied in 1-level and 2-level Food and Drug Administration (FDA)-approved clinical trials, respectively: CDA (n = 280 and 209), ACDF (n = 265 and 188).

Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial.

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 comparing the low-profile titanium ceramic composite-based Prestige LP Cervical Disc (n = 209) at two levels with ACDF (n = 188). Ten-year follow-up data from a postapproval study were available on 148 CDA and 118 ACDF patients and are reported here.

Lumbar disc arthroplasty versus anterior lumbar interbody fusion: 5-year outcomes for patients in the Maverick disc investigational device exemption study.

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 States. Additional long-term data on lumbar disc arthroplasty are still needed.

Cervical disc arthroplasty: 10-year outcomes of the Prestige LP cervical disc at a single level.

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 years postoperatively for the single-level CDA arm of an IDE study (postapproval study).

Magnetic resonance spectroscopy (MRS) can identify painful lumbar discs and may facilitate improved clinical outcomes of lumbar surgeries for discogenic pain.

Purpose: The goal of this study was to refine clinical MRS to optimize performance and then determine whether MRS-derived biomarkers reliably identify painful discs, quantify degeneration severity, and forecast surgical outcomes for chronic low back pain (CLBP) patients.

Methods: We performed an observational diagnostic development and accuracy study. Six hundred and twenty-three (623) discs in 139 patients were scanned using MRS, with 275 discs also receiving provocative discography (PD).

Treatment of Cervical Myelopathy: Long-term Outcomes of Arthroplasty for Myelopathy Versus Radiculopathy, And Arthroplasty Versus Arthrodesis for Myelopathy.

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 of CDA for myelopathy versus radiculopathy.

Summary Of Background Data: CDA for myelopathy is safe and effective in short term.

Safety and Efficiency of Cervical Disc Arthroplasty in Ambulatory Surgery Centers vs. Hospital Settings.

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 setting.

Methods: The study was a retrospective collection and analysis of data from consecutive CDA patients treated in ASCs compared to a historical control group of patients treated in hospital settings who were classified as outpatient (0 or 1-night stay) or inpatient (2 or more nights).

Serum Metal Concentrations in Patients With Titanium Ceramic Composite Cervical Disc Replacements.

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).

Observational Study of Depression in Patients Undergoing Cervical Disc Arthroplasty: Evidence of a Correlation between Pain Relief and Resolution of Depression.

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.

Methods: A cohort of 271 patients who underwent single or multi-level cervical disc arthroplasty at a single orthopedic center filled out the Neck Disability Index, Medical Outcomes Study SF-36, numerical rating scales for neck pain and arm pain, preoperatively and 12-month postoperatively.

The Effect of Workers' Compensation Status on Outcomes of Cervical Disc Arthroplasty: A Prospective, Comparative, Observational Study.

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-to-work status were analyzed at one year after surgery in an observational cohort of consecutive patients who underwent single-level or multilevel cervical disc arthroplasty for symptomatic cervical disc conditions, including radiculopathy or discogenic pain with or without radiculopathy, exclusive of myelopathy.

Optimizing success with lumbar disc arthroplasty.

Purpose: This study aimed at determining the variables that may prove useful in predicting clinical outcomes following lumbar disc arthroplasty.

Methods: 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 variables that were significantly associated with clinical outcomes.