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11,064 result(s) for "Intervertebral Disc"
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What Are Long-term Predictors of Outcomes for Lumbar Disc Herniation? A Randomized and Observational Study
Background Although previous studies have illustrated improvements in surgical cohorts for patients with intervertebral disc herniation, there are limited data on predictors of long-term outcomes comparing surgical and nonsurgical outcomes. Questions/purposes We assessed outcomes of operative and nonoperative treatment for patients with intervertebral disc herniation and symptomatic radiculopathy at 8 years from the Spine Patient Outcomes Research Trial. We specifically examined subgroups to determine whether certain populations had a better long-term outcome with surgery or nonoperative treatment. Methods Patients with symptomatic lumbar radiculopathy for at least 6 weeks associated with nerve root irritation or neurologic deficit on examination and a confirmed disc herniation on cross-sectional imaging were enrolled at 13 different clinical sites. Patients consenting to participate in the randomized cohort were assigned to surgical or nonoperative treatment using variable permuted block randomization stratified by site. Those who declined randomization entered the observational cohort group based on treatment preference but were otherwise treated and followed identically to the randomized cohort. Of those in the randomized cohort, 309 of 501 (62%) provided 8-year data and in the observational group 469 of 743 (63%). Patients were treated with either surgical discectomy or usual nonoperative care. By 8 years, only 148 of 245 (60%) of those randomized to surgery had undergone surgery, whereas 122 of 256 (48%) of those randomized to nonoperative treatment had undergone surgery. The primary outcome measures were SF-36 bodily pain, SF-36 physical function, and Oswestry Disability Index collected at 6 weeks, 3 months, 6 months, 12 months, and then annually. Further analysis studied the following factors to determine if any were predictive of long-term outcomes: sex, herniation location, depression, smoking, work status, other joint problems, herniation level, herniation type, and duration of symptoms. Results The intent-to-treat analysis of the randomized cohort at 8 years showed no difference between surgical and nonoperative treatment for the primary outcome measures. Secondary outcome measures of sciatica bothersomeness, leg pain, satisfaction with symptoms, and self-rated improvement showed greater improvement in the group randomized to surgery despite high levels of crossover. The as-treated analysis of the combined randomized and observational cohorts, adjusted for potential confounders, showed advantages for surgery for all primary outcome measures; however, this has the potential for confounding from other unrecognized variables. Smokers and patients with depression or comorbid joint problems had worse functional outcomes overall (with surgery and nonoperative care) but similar surgical treatment effects. Patients with sequestered fragments, symptom duration greater than 6 months, those with higher levels of low back pain, or who were neither working nor disabled at baseline showed greater surgical treatment effects. Conclusions The intent-to-treat analysis, which is complicated by high rates of crossover, showed no difference over 8 years for primary outcomes of overall pain, physical function, and back-related disability but did show small advantages for secondary outcomes of sciatica bothersomeness, satisfaction with symptoms, and self-rated improvement. Subgroup analyses identified those groups with sequestered fragments on MRI, higher levels of baseline back pain accompanying radiculopathy, a longer duration of symptoms, and those who were neither working nor disabled at baseline with a greater relative advantage from surgery at 8 years. Level of Evidence Level II, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.
Molecular Basis of Intervertebral Disc Degeneration and Herniations: What Are the Important Translational Questions?
Background Intervertebral disc degeneration is a common condition with few inexpensive and effective modes of treatment, but current investigations seek to clarify the underlying process and offer new treatment options. It will be important for physicians to understand the molecular basis for the pathology and how it translates to developing clinical treatments for disc degeneration. In this review, we sought to summarize for clinicians what is known about the molecular processes that causes disc degeneration. Results A healthy disc requires maintenance of a homeostatic environment, and when disrupted, a catabolic cascade of events occurs on a molecular level resulting in upregulation of proinflammatory cytokines, increased degradative enzymes, and a loss of matrix proteins. This promotes degenerative changes and occasional neurovascular ingrowth potentially contributing to the development of pain. Research demonstrates the molecular changes underlying the harmful effects of aging, smoking, and obesity seen clinically while demonstrating the variable influence of exercise. Finally, oral medications, supplements, biologic treatments, gene therapy, and stem cells hold great promise but require cautious application until their safety profiles are better outlined. Conclusions Intervertebral disc degeneration occurs where there is a loss of homeostatic balance with a predominantly catabolic metabolic profile. A basic understanding of the molecular changes occurring in the degenerating disc is important for practicing clinicians because it may help them to inform patients to alter lifestyle choices, identify beneficial or harmful supplements, or offer new biologic, genetic, or stem cell therapies.
The inflammatory response in the regression of lumbar disc herniation
Lumbar disc herniation (LDH) is highly associated with inflammation in the context of low back pain. Currently, inflammation is associated with adverse symptoms related to the stimulation of nerve fibers that may lead to pain. However, inflammation has also been indicated as the main factor responsible for LDH regression. This apparent controversy places inflammation as a good prognostic indicator of spontaneous regression of LDH. This review addresses the molecular and cellular mechanisms involved in LDH regression, including matrix remodeling and neovascularization, in the scope of the clinical decision on conservative versus surgical intervention. Based on the evidence, a special focus on the inflammatory response in the LDH context is given, particularly in the monocyte/macrophage role. The phenomenon of spontaneous regression of LDH, extensively reported in the literature, is therefore analyzed here under the perspective of the modulatory role of inflammation.
The effect of exercises done with virtual reality glasses on pain, daily life activities, and quality of life of individuals with lumbar disc hernia: a randomized controlled trial
Background Lumbar disc herniation is a prevalent condition that leads to pain, disability, and a reduction in quality of life. While conventional treatments are widely utilized, virtual reality-based exercise programs present a promising alternative. However, the effectiveness of these exercises in the rehabilitation of lumbar disc herniation remains unclear. The aim of this study was to evaluate the effects of virtual reality-based exercises on pain, daily activities, quality of life, and fall risk in individuals with lumbar disc herniation. Materials and methods This randomized controlled trial included 68 patients meeting the study criteria. Inclusion criteria: No other physical disabilities, no surgery in the last 6 months, no uncontrolled diseases, no vertigo, knee or joint issues, moderate/low balance impairment, and body mass ındex below 40. Exclusion criteria: Uncontrolled diseases, vertigo, knee/joint issues, cognitive impairments, pregnancy, inability to complete fall risk measurement, or attend follow-ups . Participants were divided into a virtual reality group ( n  = 34, Mean age ± Standard Deviation = 51.05 ± 13.39, 41.2% male, 58.8% female) and a control group ( n  = 34, Mean age ± Standard Deviation = 53.55 ± 12.25, 29.4% male, 70.6% female). The virtual reality group performed 28 sessions of virtual reality -based exercises, while the control group received routine hospital treatment. The study was conducted in a single hospital due to equipment limitations in the region. Data were collected using the Patient Information Form, Visual Analog Scale, Oswestry Disability Index, Short Form-36 Quality of Life Scale, and Fall Risk Device. Statistical analyses were performed using Statistical Package for the Social Sciences 20, including t-tests, chi-square tests, effect size analysis, and skewness/kurtosis assessments for homogeneity. Results The virtual reality group showed a significant reduction in pain (Visual Analog Scale: 3.38 ± 1.48, Cl: -2.49, -0.86, p  < 0.05) and disability (Oswestry Disability Index: 21.59 ± 6.00, Cl: -19.92, -7.38, p  < 0.05), along with significant improvements in all Short Form-36 Quality Of Life sub-dimensions ( p  < 0.05).Fall risk scores also decreased significantly in the virtual reality group (Cl: -26.57, -7.26, p  < 0.05). There were no significant baseline differences between the groups, confirming their comparability before the intervention. Conclusion Virtual reality -based exercises effectively reduced pain, improved daily activities and quality of life, and decreased fall risk in lumbar disc herniation patients, suggesting their potential as a complementary rehabilitation approach. Blinding was not applied due to the nature of the interventions, which may introduce a potential risk of bias. Trial registration This study was registered at ClinicalTrials.gov (Clinical trial number: NCT05463588; Registration date: 08/07/2022). The study was retrospectively registered.
A RCT comparing 7-year clinical outcomes of one level symptomatic cervical disc disease (SCDD) following ProDisc-C total disc arthroplasty (TDA) versus anterior cervical discectomy and fusion (ACDF)
Purpose The objective of this trial was to compare the safety and efficacy of TDA using the ProDisc-C implant to ACDF in patients with single-level SCDD between C3 and C7. Methods We report on the single-site results from a larger multicenter trial of 13 sites using an approved US Food and Drug Administration protocol (prospective, randomized controlled non-inferiority design). Patients were randomized one-to-one to either the ProDisc-C device or ACDF. All enrollees were evaluated pre- and post-operatively at regular intervals through month 84. Visual Analog Scale (VAS) for neck and arm pain/intensity, Neck Disability Index (NDI), Short-Form 36 (SF-36), and satisfaction were assessed. Results Twenty-two patients were randomized to each arm of the study. Nineteen additional patients received the ProDisc-C via continued access. NDI improved with the ProDisc-C more than with ACDF. Total range of motion was maintained with the ProDisc-C, but diminished with ACDF. Neck and arm pain improved more in the ProDisc-C than ACDF group. Patient satisfaction remained higher in the ProDisc-C group at 7 years. SF-36 scores were higher in the TDA group than ACDF group at 7 years; the difference was not clinically significant. Six additional operations (two at the same level; four at an adjacent level) were performed in the ACDF, but none in the ProDisc-C group. Conclusions The ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.
Clinical comparison of unilateral biportal endoscopic technique versus open microdiscectomy for single-level lumbar discectomy: a multicenter, retrospective analysis
Background The unilateral biportal endoscopic (UBE) technique is a minimally invasive procedure for spinal surgery, while open microscopic discectomy is the most common surgical treatment for ruptured or herniated discs of the lumbar spine. A new endoscopic technique that uses a UBE approach has been applied to conventional arthroscopic systems for the treatment of spinal disease. In this study, we aimed to compare and evaluate the perioperative parameters and clinical outcomes, including recovery from surgery, pain and life quality modification, patient’s satisfaction, and complications, between UBE and open lumbar microdiscectomy (OLM) for single-level discectomy procedures. Methods This study included 141 patients with degenerative disc disease requiring discectomy at a single level from L2–L3 to L5–S1. A total of 60 and 81 patients underwent UBE and OLM, respectively. Analysis was based on comparison of perioperative metrics, operation time (OT); estimated blood loss (EBL); length of hospital stay (HS); clinical outcomes, including assessment using the Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI); patient satisfaction (the MacNab score); and the incidence of reoperation and complications. Results The study cohort was 56.7% women, and the mean patient age was 50.98 ± 18.23 years. The mean VAS (the back and leg), MacNab score, and ODI improved significantly from the preoperative period to the last follow-up (12.92 ± 3.92) in both groups ( p  < 0.001). One week after operation, the back VAS score in the UBE group showed significantly more improvement than that in the OLM group. However, the 1-week, 3-month, and 12-month VAS (the back and leg), ODI improvement, modified MacNab score, and OT were not significantly different between the two groups. In the UBE group, EBL (34.67 ± 16.92) was smaller and HS (2.77 ± 1.2) was shorter than that of the OLM group (140.05 ± 57.8, 6.37 ± 1.39). However, OT (70.15 ± 22.0) was longer in the UBE group than in the OLM group (60.38 ± 15.5), and the difference was statistically significant. Meanwhile, the differences in the rate of surgical conversion and complications between the two groups were not statistically significant. Conclusions The UBE for single-level discectomy yielded similar clinical outcomes to OLM, including pain control, functional disability, and patient satisfaction, but incurred minimal EBL, HS, and postoperative back pain. Trial registration Not applicable.
A prospective multicenter phase I/II clinical trial to evaluate safety and efficacy of NOVOCART Disc plus autologous disc chondrocyte transplantation in the treatment of nucleotomized and degenerative lumbar disc to avoid secondary disease: study protocol for a randomized controlled trial
Background Intervertebral disc degeneration is emphasized as an important cause of low back pain. Current surgical treatment provides relief to the accompanying pain and disability but does not restore the biological function of the intervertebral disc. NOVOCART™ Disc plus, an autologous cell compound for autologous disc chondrocyte transplantation, was developed to reduce the degenerative sequelae after lumbar disc surgery or to prophylactically avoid degeneration in adjacent discs. Methods/design This is a multicenter, randomized, controlled, clinical phase I/II combination study. A total of 120 adult patients are allocated in a ratio of 2:1:1. Sample size and power calculations were performed to detect the minimal clinically important difference of 10 units, with an expected standard deviation of 12 in the Oswestry Disability Index, which is the primary outcome parameter. Secondary outcome parameters include the visual analog scale and the EQ-5D questionnaire. Changes in physical and mental health are evaluated using the Short Form-12 (SF-12). Moreover, radiological and functional outcomes are evaluated. The major inclusion criterion is a single lumbar disc herniation that requires sequestrectomy. Transplantation is performed 90 days thereafter. Study data generation (study sites) and data storage, processing, and statistical analysis are clearly separated. Discussion In this phase-I/II study, NDplus is being investigated for its clinical applicability, safety, and efficacy in the repair of herniated, nucleotomized discs, and of adjacent degenerated discs, if present. To date, autologous disc chondrocytes have not been transplanted into degenerative discs without previous disc herniation. As such, this is the first study to investigate a therapeutic as well as a prophylactic approach to treat degenerative discs of the lumbar spine. Trial registration EudraCT No: 2010-023830-22, ID NCT01640457 , 8 November 2010
Ten-Year Outcomes of 1- and 2-Level Cervical Disc Arthroplasty From the Mobi-C Investigational Device Exemption Clinical Trial
Abstract BACKGROUND Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration. OBJECTIVE To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology. METHODS This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C® Cervical Disc (Zimmer Biomet). Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr. RESULTS At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr. CONCLUSION Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease. Graphical Abstract Graphical Abstract
Intervertebral Disc Diseases PART 2: A Review of the Current Diagnostic and Treatment Strategies for Intervertebral Disc Disease
With an aging population, there is a proportional increase in the prevalence of intervertebral disc diseases. Intervertebral disc diseases are the leading cause of lower back pain and disability. With a high prevalence of asymptomatic intervertebral disc diseases, there is a need for accurate diagnosis, which is key to management. A thorough understanding of the pathophysiology and clinical manifestation aids in understanding the natural history of these conditions. Recent developments in radiological and biomarker investigations have potential to provide noninvasive alternatives to the gold standard, invasive discogram. There is a large volume of literature on the management of intervertebral disc diseases, which we categorized into five headings: (a) Relief of pain by conservative management, (b) restorative treatment by molecular therapy, (c) reconstructive treatment by percutaneous intervertebral disc techniques, (d) relieving compression and replacement surgery, and (e) rigid fusion surgery. This review article aims to provide an overview on various current diagnostic and treatment options and discuss the interplay between each arms of these scientific and treatment advancements, hence providing an outlook of their potential future developments and collaborations in the management of intervertebral disc diseases.
Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months
In a single-center, randomized trial involving 128 patients with sciatica lasting 4 to 12 months and lumbar disk herniation, diskectomy was superior to conservative care in reducing leg-pain intensity at 6 months after enrollment. Among the patients assigned to conservative care, 34% crossed over to undergo surgery.