Dataset Information

The activL(®) Artificial Disc: a next-generation motion-preserving implant for chronic lumbar discogenic pain.

ABSTRACT: Degeneration of the lumbar intervertebral discs is a leading cause of chronic low back pain in adults. Treatment options for patients with chronic lumbar discogenic pain unresponsive to conservative management include total disc replacement (TDR) or lumbar fusion. Until recently, only two lumbar TDRs had been approved by the US Food and Drug Administration - the Charité Artificial Disc in 2004 and the ProDisc-L Total Disc Replacement in 2006. In June 2015, a next-generation lumbar TDR received Food and Drug Administration approval - the activL(®) Artificial Disc (Aesculap Implant Systems). Compared to previous-generation lumbar TDRs, the activL(®) Artificial Disc incorporates specific design enhancements that result in a more precise anatomical match and allow a range of motion that better mimics the healthy spine. The results of mechanical and clinical studies demonstrate that the activL(®) Artificial Disc results in improved mechanical and clinical outcomes versus earlier-generation artificial discs and compares favorably to lumbar fusion. The purpose of this report is to describe the activL(®) Artificial Disc including implant characteristics, intended use, surgical technique, postoperative care, mechanical testing, and clinical experience to date.

SUBMITTER: Yue JJ

PROVIDER: S-EPMC4869850 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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The activL(®) Artificial Disc: a next-generation motion-preserving implant for chronic lumbar discogenic pain.

Yue James J JJ Garcia Rolando R Miller Larry E LE

Medical devices (Auckland, N.Z.) 20160510

Degeneration of the lumbar intervertebral discs is a leading cause of chronic low back pain in adults. Treatment options for patients with chronic lumbar discogenic pain unresponsive to conservative management include total disc replacement (TDR) or lumbar fusion. Until recently, only two lumbar TDRs had been approved by the US Food and Drug Administration - the Charité Artificial Disc in 2004 and the ProDisc-L Total Disc Replacement in 2006. In June 2015, a next-generation lumbar TDR received F ...[more]

PMID: 27274317

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Project description:Among the multiple causes of chronic low back pain, axial and discogenic pain are common. Various modalities of treatments are utilized in managing discogenic and axial low back pain including epidural injections. However, there is a paucity of evidence regarding the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections. In an interventional pain management practice in the US, a randomized, double-blind, active control trial was conducted. The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of discogenic origin. However, disc herniation, radiculitis, facet joint pain, or sacroiliac joint pain were excluded. Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Primary outcome measures included the pain relief-assessed by numeric rating scale of pain and functional status assessed by the, Oswestry Disability Index, Secondary outcome measurements included employment status, and opioid intake. Significant improvement or success was defined as at least a 50% decrease in pain and disability. Significant improvement was seen in 77% of the patients in Group I and 67% of the patients in Group II. In the successful groups (those with at least 3 weeks of relief with the first two procedures), the improvement was 84% in Group I and 71% in Group II. For those with chronic function-limiting low back pain refractory to conservative management, it is concluded that lumbar interlaminar epidural injections of local anesthetic with or without steroids may be an effective modality for managing chronic axial or discogenic pain. This treatment appears to be effective for those who have had facet joints as well as sacroiliac joints eliminated as the pain source.

Project description:Background and Objectives: Degenerative disk disease is a widespread chronic condition that causes diskogenic pain. Diskogenic pain can be treated with various therapy methods. Disc-FX is a revolutionary, minimally invasive, percutaneous nucleo-annuloplasty method that combines manual diskectomy with nuclear and annular remodeling using radiofrequency ablation to relieve diskogenic pain. In this study, the technical features, clinical outcomes, and complications of Disc-FX are summarized. Materials and Methods: A comprehensive literature review was performed. By exploring several databases, we collected studies on Disc-FX for treating diskogenic pain. The outcomes included perioperative data, clinical results, and complications. Results: In the 15 studies included, data from 570 patients were collected. L4-L5 was the most frequently operated level, and most cases underwent single-level procedures. The follow-up period for these patients ranged from 2 months to 24 months. One study reported a procedure time between 35 and 60 min, whereas the remaining studies reported a procedure time of less than 30 min. The mean visual analog scale score decreased from 7.22 preoperatively to 1.81 at the final follow-up. The mean numerical rating scale score decreased from 6.98 preoperatively to 3.9 at the final follow-up. The mean Japanese Orthopaedic Association score improved from 16.26 preoperatively to 25.88 in the final follow-up. The mean Oswestry Disability Index score decreased from 35.37 preoperatively to 14.66 at the final follow-up. The mean satisfaction rate (based on the Macnab criteria) was 87.6% (range, 78.4-95.2%). The total incidence of postoperative transient pain was 8.77% (50/570) after nucleo-annuloplasty using Disc-FX, and recurrence was 1.58% (9/570). Conclusions: According to our comprehensive evaluation, using percutaneous nucleo-annuloplasty for treating lumbar diskogenic diseases provided considerable pain alleviation and improved functional outcomes with fewer complications. Disc-FX is a safe and effective procedure that is a good treatment option for patients with diskogenic pain.

Project description:PurposesTo evaluate the usefulness of our original five questions in a medical interview for diagnosing discogenic low back pain (LBP), and to establish a support tool for diagnosing discogenic LBP.Materials and methodsThe degenerative disc disease (DDD) group (n = 42) comprised patients diagnosed with discogenic LBP associated with DDD, on the basis of magnetic resonance imaging findings and response to analgesic discography (discoblock). The control group (n = 30) comprised patients with LBP due to a reason other than DDD. We selected patients from those who had been diagnosed with lumbar spinal stenosis and had undergone decompression surgery without fusion. Of them, those whose postoperative LBP was significantly decreased were included in the control group. We asked patients in both groups whether they experienced LBP after sitting too long, while standing after sitting too long, squirming in a chair after sitting too long, while washing one's face, and in the standing position with flexion. We analyzed the usefulness of our five questions for diagnosing discogenic LBP, and performed receiver operating characteristic (ROC) curve analysis to develop a diagnostic support tool.ResultsThere were no significant differences in baseline characteristics, except age, between the groups. There were significant differences between the groups for all five questions. In the age-adjusted analyses, the odds ratios of LBP after sitting too long, while standing after sitting too long, squirming in a chair after sitting too long, while washing one's face, and in standing position with flexion were 10.5, 8.5, 4.0, 10.8, and 11.8, respectively. The integer scores were 11, 9, 4, 11, and 12, respectively, and the sum of the points of the five scores ranged from 0 to 47. Results of the ROC analysis were as follows: cut-off value, 31 points; area under the curve, 0.92302; sensitivity, 100%; and specificity, 71.4%.ConclusionsAll five questions were useful for diagnosing discogenic LBP. We established the scoring system as a support tool for diagnosing discogenic LBP.

Project description:BackgroundLittle information is available on vertebral motion in patients with discogenic low back pain under physiological conditions. We previously validated a combined dual fluoroscopic and magnetic resonance imaging system to investigate in vivo lumbar kinematics. The purpose of the present study was to characterize mechanical dysfunction among patients with confirmed discogenic low back pain, relative to asymptomatic controls without degenerative disc disease, by quantifying abnormal vertebral motion.MethodsTen subjects were recruited for the present study. All patients had discogenic low back pain confirmed clinically and radiographically at L4-L5 and L5-S1. Motions were reproduced with use of the combined imaging technique during flexion-extension, left-to-right bending, and left-to-right twisting movements. From local coordinate systems at the end plates, relative motions of the cephalad vertebrae with respect to caudad vertebrae were calculated at each of the segments from L2 to S1. Range of motion of the primary rotations and coupled translations and rotations were determined.ResultsDuring all three movements, the greatest range of motion was observed at L3-L4. L3-L4 had significantly greater motion than L2-L3 with left-right bending and left-right twisting movements (p < 0.05). The least motion occurred at L5-S1 for all movements; the motion at this level was significantly smaller than that at L3-L4 (p < 0.05). Range of motion during left-right bending and left-right twisting at L3-L4 was significantly larger in the degenerative disc disease group than in the normal group. The range of motion at L4-L5 was significantly larger in the degenerative group than in the normal group during flexion; however, the ranges of motion in both groups were similar during left-to-right bending and left-to-right twisting.ConclusionsThe greatest range of motion in patients with discogenic back pain was observed at L3-L4; this motion was greater than that in normal subjects, suggesting that superior adjacent levels developed segmental hypermobility prior to undergoing fusion. L5-S1 had the least motion, suggesting that segmental hypomobility ensues at this level in patients with discogenic low back pain.

Project description:Study designSecondary analysis of data from a concurrent randomized trial and cohort study.ObjectiveThe aim of this study was to determine risks and predictors of recurrent pain following standard open discectomy for subacute/chronic symptomatic lumbar disc herniation (SLDH).Summary of background dataMost previous studies of recurrence after discectomy do not explicitly define pain resolution and recurrence, and do not account for variable durations of time at risk for recurrence.MethodsWe used survival analysis methods to examine predictors of leg pain recurrence. For individuals with initial resolution of leg pain, we defined recurrent leg pain as having leg pain, receiving lumbar epidural steroid injections, or undergoing lumbar surgery subsequent to initial leg pain resolution. We calculated cumulative risks of leg pain recurrence using Kaplan-Meier survival curves, and examined predictors of recurrence using Cox proportional hazards models. We used similar methods to examine LBP recurrence.ResultsOne- and three-year cumulative risks of leg pain recurrence were 20% and 45%, respectively. One- and three- year leg pain recurrence risks were substantially lower in participants with complete initial resolution of leg pain (17% and 41%, respectively) than in those without (27% and 54%, respectively). In multivariate analyses, complete leg pain resolution (adjusted hazard ratio [aHR] 0.69; 95% confidence interval [CI] 0.52-0.90), smoking (aHR 1.68 [95% CI 1.22-2.33]), and depression (aHR 1.74 [95% CI 1.18-2.56]) predicted leg pain recurrence. The 1- and 3-year risk of LBP recurrence was 29% and 65%, respectively. LBP recurrence risk at 3 years was substantially lower in participants with complete initial resolution of LBP than in those without, but not at 1 year.ConclusionRecurrence of leg pain and LBP is common after discectomy for SLDH. Cumulative risks of both leg pain and LBP recurrence were generally lower in participants achieving complete initial resolution of pain post-discectomy.Level of evidence2.

Project description:ObjectiveTo investigate the effect of protrusion amount on pain, lumbar mobility, physical dysfunction, and the cross-sectional area of the multifidus muscle in patients with lumbar disc herniation.Methods54 male patients aged 20 to 50 years were included in this study in 2 groups. The control group (n = 18) consisted of patients with disc herniation without nerve root compression, and the study group (n = 36) consisted of patients with lumbar disc herniation and nerve root compression in 3 subgroups according to the amount of protrusion. The multifidus muscle cross-sectional area and the amount of protrusion were measured using Magnetic Resonance Imaging. Pain intensity was measured using the Visual Pain Scale, physical dysfunction was measured using the Oswestry Disability Index, flexion-extension was measured with TiltMeter, and trunk rotation was measured with smartphone applications called iPhone Compass.ResultsThere were no differences in pain levels (P > .05), mean trunk rotation movements of the affected and unaffected sides (P = .001, P = .001, P = .983, and P = .954, respectively), Oswestry Disability Index results (P = .967), or cross-sectional area sizes of the multifidus muscle (P = .866, P = .552, P = .787, respectively). There was a difference between the groups in terms of the mean trunk flexion and extension movement values (P = .001). The regression analysis indicated that there was no significant correlation between the binary variables, and the models exhibited a low explanatory rate for the dependent variable.ConclusionA relationship has been identified between lumbar disc herniation and low back pain, lumbar movement limitation, and physical functionality. Nevertheless, subsequent to the regression analysis, it became evident that the binary variables did not exhibit a noteworthy relationship, leading to a decrease in the explanatory capacity of the models for the dependent variable. In forthcoming studies, it is advisable to contemplate the augmentation of the subject pool or the incorporation of multiple independent variables into the regression analysis as potential strategies to enhance the model capability in elucidating variations in the dependent variable.

Dataset Information

The activL(®) Artificial Disc: a next-generation motion-preserving implant for chronic lumbar discogenic pain.

Publications

The activL(®) Artificial Disc: a next-generation motion-preserving implant for chronic lumbar discogenic pain.

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