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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.

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

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.

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.

Despite being considered the standard surgical procedure for symptomatic cervical disc disease, anterior cervical decompression and fusion invariably accelerates adjacent segment degeneration. Cervical total disc replacement is a motion-preserving procedure developed as a substitute to fusion. Whether cervical total disc replacement is superior to fusion remains unclear. We comprehensively searched PubMed, EMBASE, Medline, and the Cochrane Library in accordance with the inclusion criteria to identify possible studies. The retrieved results were last updated on December 12, 2014. We classified the studies as short-term and midterm follow-up. Nineteen randomized controlled trials involving 4516 cases were identified. Compared with anterior cervical decompression and fusion, cervical total disc replacement had better functional outcomes (neck disability index [NDI], NDI success, neurological success, neck pain scores reported on a numerical rating scale [NRS], visual analog scales scores and overall success), greater segmental motion at the index level, fewer adverse events and fewer secondary surgical procedures at the index and adjacent levels in short-term follow-up (P < 0.05). With midterm follow-up, the cervical total disc replacement group indicated superiority in the NDI, neurological success, pain assessment (NRS), and secondary surgical procedures at the index level (P < 0.05). The Short Form 36 (SF-36) and segmental motion at the adjacent level in the short-term follow-up showed no significant difference between the two procedures, as did the secondary surgical procedure rates at the adjacent level with midterm follow-up (P > 0.05). Cervical total disc replacement presented favorable functional outcomes, fewer adverse events, and fewer secondary surgical procedures. The efficacy and safety of cervical total disc replacement are superior to those of fusion. Longer-term, multicenter studies are required for a better evaluation of the long-term efficacy and safety of the two procedures.

Abstract BACKGROUND Ten-year follow-up data from the US Food and Drug Administration investigational device exemption trial comparing BRYAN® Cervical Disc (Medtronic, Dublin, Ireland) arthroplasty to anterior cervical discectomy and fusion (ACDF) demonstrated that disc arthroplasty maintained range of motion and improvements in overall success and neck disability. OBJECTIVE To compare the 10-yr rates of symptomatic adjacent level disease requiring surgery (SALDRS). METHODS Prospective randomized trial data were analyzed comparing BRYAN® Cervical Disc arthroplasty to ACDF for single-level cervical disc disease with concordant radiculopathy or myelopathy with clinicoradiographic analysis at 10 yr. Secondarily, 84-mo data were pooled with PRESTIGE® Cervical Disc arthroplasty (Medtronic) study data to provide overall rates of SALDRS. RESULTS Significantly greater overall success was maintained at every postoperative interval with an overall success rate of 81.3% with BRYAN® disc and 66.3% with ACDF (P = .005) without loss of motion preservation (8.69° vs 0.60°). Reoperation at adjacent levels up to the 120-mo visit was 9.7% in the arthroplasty group and 15.8% in the ACDF group (P = .146). The combined data from BRYAN® and Prestige ST demonstrate that BRYAN® and Prestige disc groups had a lower rate of second surgeries at the adjacent levels, up to the 84-mo visit, compared to the combined ACDF groups (6.9% vs 11.7%; P = .023). CONCLUSION Compared with ACDF, fewer patients with the BRYAN® disc required surgery for symptomatic adjacent level degeneration, but this did not achieve statistical significance. Analysis of combined study data using Bryan and Prestige discs shows significant differences in SADLRS as early as 7 yr.

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

Purpose This multicenter clinical study was performed to assess the safety and effectiveness of Trinity Evolution ® (TE), a viable cellular bone allograft, in combination with a PEEK interbody spacer and supplemental anterior fixation in patients undergoing anterior cervical discectomy and fusion (ACDF). Methods In a prospective, multi-center study, 31 patients that presented with symptomatic cervical degeneration at one vertebral level underwent ACDF with a PEEK interbody spacer (Orthofix, Inc., Lewisville, TX, USA) and supplemental anterior fixation. In addition all patients had the bone graft substitute, Trinity Evolution (Musculoskeletal Transplant Foundation, Edison, NJ, USA), placed within the interbody spacer. At 6 and 12 months, radiographic fusion was evaluated as determined by independent radiographic review of angular motion (≤4°) from flexion/extension X-rays combined with presence of bridging bone across the adjacent endplates on thin cut CT scans. In addition other metrics were measured including function as assessed by the Neck Disability Index (NDI), and neck and arm pain as assessed by individual Visual Analog Scales (VAS). Results The fusion rate for patients using a PEEK interbody spacer in combination with TE was 78.6 % at 6 months and 93.5 % at 12 months. When considering high risk factors, 6-month fusion rates for patients that were current or former smokers, diabetic, overweight or obese/extremely obese were 70 % (7/10), 100 % (1/1), 70 % (7/10), and 82 % (9/11), respectively. At 12 months, the fusion rates were 100 % (12/12), 100 % (2/2), 100 % (11/11) and 85 % (11/13), respectively. Neck function, and neck/arm pain were found to significantly improve at both time points. No serious allograft related adverse events occurred and none of the 31 patients had subsequent additional cervical surgeries. Conclusions Patients undergoing single-level ACDF with TE in combination with a PEEK interbody spacer and supplemental anterior fixation had a high rate of fusion success without serious allograft-related adverse events.

Transforaminal endoscopic lumbar discectomy (TELD) is regarded as an effective treatment option for soft lumbar disc herniation (LDH). There have been few studies evaluating the long-term outcomes of endoscopic procedures compared with conventional surgery. The objective of this study was to demonstrate the clinical outcomes of TELD compared with those of open lumbar microdiscectomy. Between January 2009 and September 2011, 335 consecutive patients with symptomatic LDH were treated with decompressive discectomy, either TELD or open microdiscectomy. Patients were prospectively entered into the clinical database and their records were retrospectively reviewed. Hospital and outpatient surgical center. Data from 298 patients who were treated with decompressive discectomy, either TELD or open microdiscectomy, were evaluated with a minimum 5-year follow-up period. Among them, 146 patients were treated using TELD (TELD group), and the remaining 152 patients using open microdiscectomy (Open group). Perioperative data and clinical outcomes were evaluated using the visual analog scale (VAS), the Oswestry Disability Index (ODI), and the modified Macnab criteria. The VAS and ODI significantly improved in both groups. The rate of excellent or good outcomes was 88.36% and 87.5% in the TELD and Open group, respectively. The reoperation rate was 4.2% and 3.3% in the TELD and Open group, respectively. There were no significant differences in the clinical outcomes; however, operative time, hospital stay, and time to return to work were significantly shorter in the TELD group (P < 0.01). First, the patient selection was not randomized; therefore, the risk of bias might be increased. Second, this study lacks analysis of the radiographic changes related to the degenerative change over the long-term follow-up period. The long-term results of TELD for soft LDH are comparable to those of conventional open microdiscectomy. The selective endoscopic discectomy technique under local anesthesia provides the typical advantages of minimally invasive procedures such as a shorter operation time, hospital stay, and recovery time. Endoscopic, discectomy, hospital stay, lumbar disc, microscopic, operative time, return to work, transforaminal.

BackgroundA larger defect in the annulus fibrosus following lumbar discectomy is a well-known risk factor for reherniation. Procedures intended to prevent reherniation by sealing or occluding the annular defect warrant study in high-risk patients. This study sought to determine 3-year results of lumbar discectomy with a bone-anchored annular closure device (ACD) or lumbar discectomy only (controls) in patients at high risk for reherniation.MethodsThis multicenter randomized trial enrolled patients with sciatica due to lumbar intervertebral disc herniation who failed conservative treatment. Patients with large annular defects after lumbar limited microdiscectomy were intraoperatively randomly assigned to receive ACD or control. Clinical and imaging follow-up was performed at routine intervals over 3 years. Main outcomes included rate of reherniations, reoperations, and endplate changes; leg and back pain scores on a visual analogue scale; Oswestry Disability Index (ODI); Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36; and adverse events adjudicated by a data safety monitoring board.ResultsAmong 554 randomized patients, the modified intent-to-treat population consisted of 272 patients in which ACD implantation was attempted and 278 receiving control; device implantation was not attempted in 4 patients assigned to ACD. Outcomes at 3 years favored ACD for symptomatic reherniation (14.8% vs. 29.5%; P < 0.001), reoperation (11.0% vs. 19.3%; P = 0.007), leg pain (21 vs. 30; P < 0.01), back pain (23 vs. 30; P = 0.01), ODI (18 vs. 23; P = 0.02), PCS (47 vs. 44; P < 0.01), and MCS (52 vs. 49; P < 0.01). The frequency of all-cause serious adverse events was comparable between groups (42.3% vs. 44.5%; P = 0.61).ConclusionsThe addition of a bone-anchored ACD in patients with large annular defects following lumbar discectomy reduces the risk of reherniation and reoperation, and has a similar safety profile over 3-year follow-up compared with lumbar limited discectomy only.Trial registrationClinicalTrials.gov NCT01283438