Technical Note on the Role of Kambin's Triangle in the Evolution of Total Joint Replacement of the Lumbar Spine.

We provide a historical and technical perspective on the evolution of Kambin's triangle as a safe working corridor for percutaneous access to the intervertebral disc to an anatomically expanded space to accommodate and facilitate open lumbar total joint replacement. The nearly 6-decade progression from intradiscal access in the intact lumbar spine to an enlarged working space following facetectomy to accommodate a transforaminal lumbar interbody fusion, and eventual further expansion via pedicle vertebral body osteotomy to support motion preservation with total joint replacement, represents a unique evolutionary pathway in surgical technique development. For each of these steps in evolution, we detail and provide the historical context of the corresponding surgical modifications required to expand the original anatomical boundaries of Kambin's triangle. It is postulated that the introduction of machine learning technologies coupled with innovations in robotics, materials science, and advanced imaging will further accelerate and refine the adaptation of more complex, precise, and efficacious surgical procedures to treat spinal degeneration via this working corridor.

Are We Finally Ready for Total Joint Replacement of the Spine? An Extension of Charnley's Vision.

Professor Sir John Charnley has been rightfully hailed as a visionary innovator for conceiving, designing, and validating the Operation of the Century-the total hip arthroplasty. His groundbreaking achievement forever changed the orthopedic management of chronically painful and dysfunctional arthritic joints. However, the well-accepted surgical approach of completely removing the diseased joint and replacing it with a durable and anatomically based implant never translated to the treatment of the degenerated spine. Instead, decompression coupled with fusion evolved into the workhorse intervention. In this commentary, the authors explore the reasons why arthrodesis has remained the mainstay over arthroplasty in the field of spine surgery as well as discuss the potential shift in the paradigm when it comes to treating degenerative lumbar disease.

In Vitro Wear of a Novel Vitamin E Crosslinked Polyethylene Lumbar Total Joint Replacement.

BACKGROUND: A novel, lumbar total joint replacement (TJR) design has been developed to treat degeneration across all three columns of the lumbar spine (anterior, middle, and posterior columns). Thus far, there has been no in vitro studies that establish the preclinical safety profile of the vitamin E-stabilized highly crosslinked polyethylene (VE-HXLPE) lumbar TJR relative to historical lumbar anterior disc replacement for the known risks of wear and impingement faced by all motion preserving designs for the lumbar spine. QUESTIONS/PURPOSE: In this study we asked, (1) what is the wear performance of the VE-HXLPE lumbar TJR under ideal, clean conditions? (2) Is the wear performance of VE-HXLPE in lumbar TJR sensitive to more aggressive, abrasive conditions? (3) How does the VE-HXLPE lumbar TJR perform under impingement conditions? METHOD: A lumbar TJR with bilateral VE-HXLPE superior bearings and CoCr inferior bearings was evaluated under clean, impingement, and abrasive conditions. Clean and abrasive testing were guided by ISO 18192-1 and impingement was assessed as per ASTM F3295. For abrasive testing, CoCr components were scratched to simulate in vivo abrasion. The devices were tested for 10 million cycles (MC) under clean conditions, 5 MC under abrasion, and 1 MC under impingement. RESULT: Wear rates under clean and abrasive conditions were 1.2 ± 0.5 and 1.1 ± 0.6 mg/MC, respectively. The VE-HXLPE components demonstrated evidence of burnishing and multidirectional microscratching consistent with microabrasive conditions with the cobalt chromium spherical counterfaces. Under impingement, the wear rates ranged between 1.7 ± 1.1 (smallest size) and 3.9 ± 1.1 mg/MC (largest size). No functional or mechanical failure was observed across any of the wear modes. CONCLUSIONS: Overall, we found that that a VE-HXLPE-on-CoCr lumbar total joint replacement design met or exceeded the benchmarks established by traditional anterior disc replacements, with wear rates previously reported in the literature ranging between 1 and 15 mg/MC. CLINICAL RELEVANCE: The potential clinical benefits of this novel TJR design, which avoids long-term facet complications through facet removal with a posterior approach, were found to be balanced by the in vitro tribological performance of the VE-HXLPE bearings. Our encouraging in vitro findings have supported initiating an FDA-regulated clinical trial for the design which is currently under way.

Impact of Cervical Disc Arthroplasty vs Anterior Cervical Discectomy and Fusion on Driving Disability: Post Hoc Analysis of a Randomized Controlled Trial With 10-Year Follow-Up.

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 improvement at 10-year follow-up after a 2-level procedure. METHODS: In the original randomized controlled trial, patients with cervical radiculopathy or myelopathy at 2 levels underwent CDA or ACDF. The driving disability question from the Neck Disability Index was rated from 0 to 5 years preoperatively and up to 10 years postoperatively. Severity of driving disability was categorized into "none" (score 0), "mild" (1 or 2), and "severe" (3, 4, or 5). Score and severity were compared between groups. RESULTS: Out of 397 patients, 148 CDA and 118 ACDF patients had 10-year follow-up. Driving disability scores were not different between the groups preoperatively (CDA: 2.65; ACDF: 2.71, P = 0.699). Postoperatively, the scores in the CDA group were significantly lower than those in the ACDF group at 5 (0.60 vs 1.08, P ≤ 0.001) and 10 years (0.66 vs 1.07, P = 0.001). Mean score improvement in the CDA group was significantly greater than the ACDF group at 10-year follow-up (-1.94 vs -1.63, P = 0.003). The majority of patients reported severe driving disability (CDA: 56.9%, ACDF: 58.0%, P = 0.968) before surgery. After surgery, a greater proportion of patients in the CDA group had neck pain-free driving compared with the ACDF group at 5 (63.3% vs 41.8%, P < 0.001) and 10 years (61.8% vs 41.2%, P = 0.003). CONCLUSION: In patients with cervical radiculopathy/myelopathy and 2-level disease, CDA provided greater improvements in driving disability as compared with ACDF at 10-year follow-up. This is the first report of its kind. This finding may be attributable to preservation of motion associated with CDA. CLINICAL RELEVENCE: This study provides valuable information regarding the improvement of driving disability after both CDA and ACDF. It demonstrates that both procedures result in significant improvements, with CDA resulting in even better improvements than ACDF, up to 10 year follow-up.

Loading of the lumbar spine during transition from standing to sitting: effect of fusion versus motion preservation at L4-L5 and L5-S1.

BACKGROUND CONTEXT: Transition from standing to sitting significantly decreases lumbar lordosis with the greatest lordosis-loss occurring at L4-S1. Fusing L4-S1 eliminates motion and thus the proximal mobile segments maybe recruited during transition from standing to sitting to compensate for the loss of L4-S1 mobility. This may subject proximal segments to supra-physiologic flexion loading. PURPOSE: Assess effects of instrumented fusion versus motion preservation at L4-L5 and L5-S1 on lumbar spine loads and proximal segment motions during transition from standing to sitting. STUDY DESIGN: Biomechanical study using human thoracolumbar spine specimens. METHODS: A novel laboratory model was used to simulate lumbosacral alignment changes caused by a person's transition from standing to sitting in eight T10-sacrum spine specimens. The sacrum was tilted in the sagittal plane while constraining anterior-posterior translation of T10. Continuous loading-data and segmental motion-data were collected over a range of sacral slope values, which represented transition from standing to different sitting postures. We compared different constructs involving fusions and motion preserving prostheses across L4-S1. RESULTS: After L4-S1 fusion, the sacrum could not be tilted as far posteriorly compared to the intact spine for the same applied moment (p<.001). For the same reduction in sacral slope, L4-S1 fusion induced 2.9 times the flexion moment in the lumbar spine and required 2.4 times the flexion motion of the proximal segments as the intact condition (p<.001). Conversely, motion preservation at L4-S1 restored lumbar spine loads and proximal segment motions to intact specimen levels during transition from standing to sitting. CONCLUSIONS: In general, sitting requires lower lumbar segments to undergo flexion, thereby increasing load on the lumbar disks. L4-S1 fusion induced greater moments and increased flexion of proximal segments to attain a comparable seated posture. Motion preservation using a total joint replacement prosthesis at L4-S1 restored the lumbar spine loads and proximal segment motion to intact specimen levels during transition from standing to sitting. CLINICAL SIGNIFICANCE: After L4-S1 fusion, increased proximal segment loading during sitting may cause discomfort in some patients and may lead to junctional breakdown over time. Preserving motion at L4-S1 may improve patient comfort and function during activities of daily living, and potentially decrease the need for adjacent level surgery.

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. RESULTS: The grade III/IV HO incidence at either or both index levels was 24.2% (48/198) at 2 years and 39.0% (57/146) at 10 years. No statistical difference was found in overall success; neurological success; or Neck Disability Index (NDI), neck pain, arm pain, or SF-36 Physical Component Summary (PCS) scores between the HO subgroups (grade 0-II vs III/IV) at either 2 or 10 years. The cumulative rate of possible implant-related adverse events (AEs) was higher in patients having grade III/IV HO at 2 years (56.3%) and 10 years (47.8%) compared with those having grade 0-II HO at 2 years (24.4%) and 10 years (17.9%), specifically in 2 subcategories: spinal events and HOs reported by the investigators. No statistical difference was found between the HO subgroups in possible implant-related serious AEs or secondary surgeries at the index or adjacent levels. The average angular ROMs at index levels were lower in subjects with higher-grade HO at 2 and 10 years. The average ROMs at the superior level were 8.8°, 6.6°, 3.2°, and 0.3°, respectively, for the HO grade 0/I, II, III, and IV groups at 10 years, and 7.9°, 6.2°, 3.7°, and 0.6°, respectively, at the inferior level. CONCLUSIONS: Radiographically severe (grade III or IV) HO after CDA with the Prestige LP disc at 2 levels did not significantly affect efficacy or safety outcomes (severe AEs or secondary surgeries). However, severe HO, particularly grade IV HO, significantly limited ROM, as expected.

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). Data from these studies were used to compare 1- versus 2-level procedures: the propensity score method was used to adjust for potential confounding effects, and adjusted mean outcome safety and efficacy scores at 2 and 7 years postsurgery were compared between 1-level and 2-level procedures within treatment type. RESULTS: One-level and 2-level procedures had similar rates of improvement in overall success and patient-reported outcomes scores for both CDA and ACDF. There were no statistical differences in rates of implant-related adverse events (AEs) or serious implant-related AEs between 1-level and 2-level CDA. The 7-year rate of implant-related AEs was higher for 2-level than 1-level ACDF (27.7% vs 18.9%, P ≤ .036), though the rates of serious implant-related AEs between ACDF groups did not differ significantly. Secondary surgery rates were not statistically different between 1-level and 2-level procedures (CDA or ACDF) at the index or adjacent levels at 2 or 7 years. Grade IV heterotopic ossification at 7 years was reported in 4.6% of 1-level CDA patients and 8.6%/7.3% at the superior/inferior levels, respectively, of 2-level CDA patients. CONCLUSIONS: One- and 2-level CDA appear equally safe and effective in the treatment of cervical degenerative disc disease. Two-level ACDF appears to be as effective as 1-level ACDF but with a higher rate of some AEs at long-term follow-up. LEVEL OF EVIDENCE: 2. CLINICAL TRIALS: clinicaltrials.gov: NCT00667459, NCT00642876, and NCT00637156.

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. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative follow-up intervals for up to 10 years. The primary endpoint was overall success, a composite variable that included key safety and efficacy considerations. Ten-year follow-up rates were 86.0% for CDA and 84.9% for ACDF. RESULTS: From 2 to 10 years, CDA demonstrated statistical superiority over ACDF for overall success, with rates at 10 years of 80.4% versus 62.2%, respectively (posterior probability of superiority [PPS] = 99.9%). Neck Disability Index (NDI) success was also superior, with rates at 10 years of 88.4% versus 76.5% (PPS = 99.5%), as was neurological success (92.6% vs 86.1%; PPS = 95.6%). Improvements from preoperative results in NDI and neck pain scores were consistently statistically superior for CDA compared to ACDF. All other study effectiveness measures were at least noninferior for CDA compared to ACDF through the 10-year follow-up period, including disc height. Mean angular ranges of motion at treated levels were maintained in the CDA group for up to 10 years. The rates of grade IV heterotopic ossification (HO) at the superior and inferior levels were 8.2% and 10.3%, respectively. The rate of severe HO (grade III or IV) did not increase significantly from 7 years (42.4%) to 10 years (39.0%). The CDA group had fewer serious (grade 3-4) implant-related or implant/surgical procedure-related adverse events (3.8% vs 8.1%; posterior mean 95% Bayesian credible interval [BCI] of the log hazard ratio [LHR] -0.92 [-1.88, -0.01]). The CDA group also had statistically fewer secondary surgical procedures at the index levels (4.7%) than the ACDF group (17.6%) (LHR [95% BCI] -1.39 [-2.15, -0.61]) as well as at adjacent levels (9.0% vs 17.9%). CONCLUSIONS: The Prestige LP Cervical Disc, implanted at two adjacent levels, maintains improved clinical outcomes and segmental motion 10 years after surgery and is a safe and effective alternative to fusion.Clinical trial registration no.: NCT00637156 (clinicaltrials.gov).

Comparison of vertebroplasty and balloon kyphoplasty for treatment of vertebral compression fractures: a meta-analysis of the literature.

BACKGROUND CONTEXT: Previous investigators have reported on benefits and risks associated with vertebroplasty and kyphoplasty, but there are limited comparison data available. Additionally, much of the data is from retrospective studies and case series. PURPOSE: The purpose of this study is to review the literature and perform a meta-analysis of pain relief and risk of complications associated with vertebroplasty versus kyphoplasty. STUDY DESIGN: A meta-analysis of the literature on effectiveness of pain control and risk of complications after vertebroplasty versus balloon kyphoplasty. Outcomes measures include visual analog scale and complications. METHODS: A comprehensive review of the literature was performed. All studies providing information on pain relief and complications were included. Preoperative, postoperative, and change in visual analog scale (VAS) scores were tabulated. Data were analyzed to identify if a significant improvement in the VAS score occurred. Changes in the VAS scores were compared for vertebroplasty and kyphoplasty to determine if there was a significant difference. RESULTS: A total of 1,036 abstracts were identified. Of these, 168 studies met the inclusion criteria. Mean pre- and postoperative VAS scores for vertebroplasty were 8.36 and 2.68, respectively, with a mean change of 5.68 (p<.001). The mean pre- and postoperative VAS scores for kyphoplasty were 8.06 and 3.46, respectively, with a mean change of 4.60 (p<.001). There was statistically greater improvement found with vertebroplasty versus kyphoplasty (p<.001). The risk of new fracture was 17.9% with vertebroplasty versus 14.1% with kyphoplasty (p<.01). The risk of cement leak was 19.7% with vertebroplasty versus 7.0% with kyphoplasty (p<.001). CONCLUSIONS: Both vertebroplasty and kyphoplasty provided significant improvement in VAS pain scores. Vertebroplasty had a significantly greater improvement in pain scores but also had statistically greater risk of cement leakage and new fracture.

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. MATERIALS AND METHODS: We analyzed Neck Disability Index (NDI), neck/arm pain, SF-36, neurological status, adverse events (AEs), and secondary surgeries at index and adjacent levels. RESULTS: All groups improved significantly for NDI, neck/arm pain, and physical component summary (PCS) scores from preoperative to postoperative. CDA Myelopathy versus CDA Radiculopathy: 2- and 7-year improvements were not significantly different. The 7-year score improvements for CDA Myelopathy and CDA Radiculopathy were: NDI (37.8 vs. 35.8, P=0.352), neck pain (12.0 vs. 12.1, P=0.477), arm pain (11.6 vs. 9.6, P=0.480), and PCS (14.1 vs. 13.7, P=0.863). The 2 groups had similar proportions of patients who maintained or improved their neurological status (87.2% vs. 93.5%, P=0.218), similar rates of serious AEs (54.5% vs. 57.5%, P=0.291) and similar rates of secondary surgeries at index (3.7% vs. 4.4%, P=0.839) and adjacent levels (3.7% vs. 7.6%, P=0.367). CDA Myelopathy versus ACDF myelopathy: 2 and 7-year improvements were not significantly different. The 7-year CDA and ACDF score improvements were: NDI (37.8 vs. 31.1, P=0.147), neck pain (12.0 vs. 10.4, P=0.337), arm pain (11.6 vs. 11.4, P=0.791), and PCS (14.1 vs. 11.2, P=0.363). The 2 groups had statistically similar proportions who maintained or improved their neurological status (87.2% vs. 96.2%, P=0.409), statistically similar overall rates of secondary surgeries at the index levels (3.7% vs. 9.4%, P=0.374), and statistically similar rates of secondary surgeries at adjacent levels (3.7% vs. 15.4%, P=0.088). CDA group demonstrated lower rates of serious AEs than ACDF (54.5% vs. 65.9%, P=0.019). CONCLUSIONS: CDA for myelopathy is a safe and effective long-term treatment.

Redundant publications in the orthopedic literature.

Rates of redundant publications in the general surgery literature are approximately 14%. This article identifies the rate of redundant publications in the orthopedic literature. All original articles published during the year 2000 in The Journal of Bone and Joint Surgery (American Volume), Journal of Orthopaedic Trauma, Journal of Spinal Disorders, and Spine were searched using PubMed. Redundancy rate was 4 (3.15%) of 127 for The Journal of Bone and Joint Surgery (American volume), zero (0%) of 70 for Journal of Orthopaedic Trauma, 2 (2.90%) of 69 for Journal of Spinal Disorders, and 11 (3.12%) of 353 for Spine.

Transforaminal lumbar interbody fusion: a retrospective study of long-term pain relief and fusion outcomes.

No long-term studies exist on the effectiveness of transforaminal lumbar interbody fusion. This study sought to determine postoperative pain, disability, and fusion status of transforaminal lumbar interbody fusion patients after > or = 4 years to establish long-term outcomes. A retrospective analysis of 42 patients with minimum 4-year follow-up was conducted. Patients completed visual analog pain scale (VAS) and Oswestry functional capacity evaluation pre- and postoperatively. Statistically significant improvement was noted in VAS and Oswestry functional capacity evaluation scores. Transforaminal lumbar interbody fusion is effective in alleviating intractable back pain over an extended time period. Solid radiographic fusion is unnecessary for clinically successful outcomes.

Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial.

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 prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted at 30 US centers, comparing the low-profile titanium ceramic composite-based Prestige LP ADR (n = 209) at 2 levels with ACDF (n = 188). Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative intervals to 84 months. The primary end point was overall success, a composite variable that included key safety and efficacy considerations. RESULTS At 84 months, the Prestige LP ADR demonstrated statistical superiority over fusion for overall success (observed rate 78.6% vs 62.7%; posterior probability of superiority [PPS] = 99.8%), Neck Disability Index success (87.0% vs 75.6%; PPS = 99.3%), and neurological success (91.6% vs 82.1%; PPS = 99.0%). All other study effectiveness measures were at least noninferior for ADR compared with ACDF. There was no statistically significant difference in the overall rate of implant-related or implant/surgical procedure-related adverse events up to 84 months (26.6% and 27.7%, respectively). However, the Prestige LP group had fewer serious (Grade 3 or 4) implant- or implant/surgical procedure-related adverse events (3.2% vs 7.2%, log hazard ratio [LHR] and 95% Bayesian credible interval [95% BCI] -1.19 [-2.29 to -0.15]). Patients in the Prestige LP group also underwent statistically significantly fewer second surgical procedures at the index levels (4.2%) than the fusion group (14.7%) (LHR -1.29 [95% BCI -2.12 to -0.46]). Angular range of motion at superior- and inferior-treated levels on average was maintained in the Prestige LP ADR group to 84 months. CONCLUSIONS The low-profile artificial cervical disc in this study, Prestige LP, implanted at 2 adjacent levels, maintains improved clinical outcomes and segmental motion 84 months after surgery and is a safe and effective alternative to fusion. Clinical trial registration no.: NCT00637156 (clinicaltrials.gov).

Cervical disc arthroplasty with the Prestige LP disc versus anterior cervical discectomy and fusion, at 2 levels: results of a prospective, multicenter randomized controlled clinical trial at 24 months.

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 (209) underwent arthroplasty using a Prestige LP artificial disc, and control patients (188) underwent ACDF with a cortical ring allograft and anterior cervical plate. Patients were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Efficacy and safety outcomes were measured according to the Neck Disability Index (NDI), Numeric Rating Scales for neck and arm pain, 36-Item Short-Form Health Survey (SF-36), gait abnormality, disc height, range of motion (investigational) or fusion (control), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all 4 of the following criteria were met: 1) NDI score improvement of ≥ 15 points over the preoperative score, 2) maintenance or improvement in neurological status compared with preoperatively, 3) no serious AE caused by the implant or by the implant and surgical procedure, and 4) no additional surgery (supplemental fixation, revision, or nonelective implant removal). Independent statisticians performed Bayesian statistical analyses. RESULTS The 24-month rates of overall success were 81.4% for the investigational group and 69.4% for the control group. The posterior mean for overall success in the investigational group exceeded that in the control group by 0.112 (95% highest posterior density interval = 0.023 to 0.201) with a posterior probability of 1 for noninferiority and 0.993 for superiority, demonstrating the superiority of the investigational group for overall success. Noninferiority of the investigational group was demonstrated for all individual components of overall success and individual effectiveness end points, except for the SF-36 Mental Component Summary. The investigational group was superior to the control group for NDI success. The proportion of patients experiencing any AE was 93.3% (195/209) in the investigational group and 92.0% (173/188) in the control group, which were not statistically different. The rate of patients who reported any serious AE (Grade 3 or 4) was significantly higher in the control group (90 [47.9%] of 188) than in the investigational group (72 [34.4%] of 209) with a posterior probability of superiority of 0.996. Radiographic success was achieved in 51.0% (100/196) of the investigational patients (maintenance of motion without evidence of bridging bone) and 82.1% (119/145) of the control patients (fusion). At 24 months, heterotopic ossification was identified in 27.8% (55/198) of the superior levels and 36.4% (72/198) of the inferior levels of investigational patients. CONCLUSIONS Arthroplasty with the Prestige LP cervical disc is as effective and safe as ACDF for the treatment of cervical DDD at 2 contiguous levels and is an alternative treatment for intractable radiculopathy or myelopathy at 2 adjacent levels. Clinical trial registration no.: NCT00637156 ( clinicaltrials.gov ).

A comparison of outcomes of anterior cervical discectomy and fusion in patients with and without radicular symptoms.

Anterior cervical discectomy and fusion (ACDF) is commonly performed for degenerative conditions of the cervical spine with good to excellent results. There is controversy over the use of ACDF for patients with axial neck pain alone. A retrospective review of 202 patients from two private practice orthopaedic spine surgeons following ACDF with 39-month mean follow-up was performed. Patients completed pain drawings, pre- and postoperative visual analog pain scales (VAS), Oswestry functional capacity evaluations (OSW), and a postoperative neck disability index. Forty-one patients had axial neck pain alone, and 161 had radicular pain with or without neck pain. There were significant improvements in VAS and OSW scores following surgery for the combined study population as well as the neck pain only and radicular pain groups (p < .01). ACDF can be effectively used for treatment of patients with axial neck pain without radicular symptoms.

A treatment and outcomes analysis of patients with coccydynia.

BACKGROUND CONTEXT: Coccydynia is a painful condition of the terminal portion of the spine often resulting from direct trauma, childbirth or unknown etiology. This is a relatively rare condition with no universally accepted treatment protocol. PURPOSE: To more clearly determine the optimal treatment for patients with coccydynia and to assess the outcomes after conservative and surgical therapy. STUDY DESIGN: Retrospective review of outcomes of all patients presenting with symptoms of coccydynia during a 5-year period. PATIENT SAMPLE: Thirty-two patients presented to an orthopedic spine surgeon during a 5-year period with symptoms of coccydynia. OUTCOME MEASURES: Patients completed visual analog pain scales (VAS) and the Oswestry (OSW) functional capacity index. METHODS: Of the 32 patients in the study, 4 (13%) were treated with nonsteroidal anti-inflammatory drugs (NSAIDs) alone, 17 (53%) were treated with NSAIDs followed by local injections and 11 (34%) underwent coccygectomy after failure of NSAIDs and local injections. Patients completed VAS and OSW forms. Pain drawings were also completed. RESULTS: Patients undergoing surgery had significantly greater pretreatment VAS scores (8.3 vs 5.4, p=.002). Surgical patients also had greater OSW scores, but not significantly (36.6 vs 24.2, p=.223). Marked improvement was reported by 9 of 11 (82%) surgical patients. Three of 11 (27%) surgical patients developed wound infections and 1 (9%) wound dehiscence. All infections resolved following irrigation and debridement and a short course of oral antibiotics. CONCLUSIONS: Patients with coccydynia should be managed conservatively when possible. Treatment should include NSAIDs and local steroid injections. Patients will often require repeat injections over time. Surgery can offer reasonable results for patients failing conservative treatment, but they should be warned of the high rate of infection.

Use of electrical bone stimulation in spinal fusion.

Spinal fusion is commonly done to manage deformity, restore stability, and eliminate excessive motion at specific spinal levels. Pseudarthrosis limits the clinical success of spinal fusion. Three types of electrical stimulation, which is used to manage non-union in long bones, recently have been applied in an attempt to enhance the rate of spinal fusion. Direct current electrical stimulation is internal and thus eliminates dependence on patient compliance. Pulsed electromagnetic fields and capacitively coupled electrical stimulation are external techniques that require patient compliance but do not have the increased risk associated with implantable devices. Firm conclusions about efficacy are difficult to establish because of inconsistencies in both determining a reliable, reproducible end point for fusion and in incorporating the effect of patient parameters. Most data indicate a positive effect for use of direct current stimulation, but further studies are necessary to determine its appropriateness as an adjuvant to spinal fusion.

Dysphagia caused by anterior cervical osteophytes: a case report.

This 79-year-old man had a several-year history of dysphagia. On presentation, he spoke with difficulty but was not short of breath, and hemoptysis was present. A 17-mm osteophyte anterior to C3-C4 encroached on the posterior aspect of the oral pharynx and esophagus. The patient underwent C3-C6 anterior ostectomy; recovery was complete within 4 weeks.

Vertebroplasty: a new treatment strategy for osteoporotic compression fractures.

Vertebroplasty is a procedure in which bone cement is injected into a fractured vertebral body in an attempt to stabilize fractured segments and reduce pain. This procedure was originally used to treat spinal lesions caused by metastases and has recently been used to treat severe bone loss caused by osteoporosis. In this article, we review the current treatment for osteoporosis, introduce vertebroplasty with its associated efficacy and risks, and describe kyphoplasty.

Preliminary experience with a new surgical treatment for dysphagia due to anterior cervical osteophytes.

A technique for surgical treatment of anterior cervical osteophytes is presented. A midline trough is created in the osteophytes using a burr under fluoroscopy down to the anterior cervical line. A rongeur is used to remove the remaining osteophytes while protecting the lateral soft tissues. Two patients presented with symptoms of progressive dysphagia secondary to anterior cervical osteophytes. Each underwent surgical ostectomy without complication after failing conservative treatment. This technique provides a safe, effective method to remove anterior cervical osteophytes.