Despite evidence of its safety and effectiveness, the use of lumbar disc arthroplasty has been slow to expand due in part to concerns about late complications and the risks of revision surgery associated with early devices. More recently, FDA approval of newer devices and improving reimbursements have reversed this trend in the United States. Additional long-term data on lumbar disc arthroplasty are still needed. This study reports the 5-year results of the FDA investigational device exemption clinical trial of the Medtronic Spinal and Biologics\' Maverick total disc replacement.
Patients with single-level degenerative disc disease from L4 to S1 were randomized 2:1 at 31 investigational sites. In the period from April 2003 to August 2004, 405 patients received the investigational device and 172 patients underwent the control procedure of anterior lumbar interbody fusion. Outcome measures included the Oswestry Disability Index (ODI), numeric rating scales (NRSs) for back and leg pain, the SF-36, disc height, interbody motion, heterotopic ossification (investigational device), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all of the following criteria were met: 1) ODI score improvement ≥ 15 points over the preoperative score; 2) maintenance or improvement in neurological status compared with preoperatively; 3) disc height success, that is, no more than a 2-mm reduction in anterior or posterior height; 4) no serious AEs caused by the implant or by the implant and the surgical procedure; and 5) no additional surgery classified as a failure.
Compared to that in the control group, improvement in the investigational group was statistically greater according to the ODI and SF-36 Physical Component Summary (PCS) at 1, 2, and 5 years; the NRS for back pain at 1 and 2 years; and the NRS for leg pain at 1 year. The rates of heterotopic ossification increased over time: 1.0% (4/382) at 1 year, 2.6% (9/345) at 2 years, and 5.9% (11/187) at 5 years. Investigational patients had fewer device-related AEs and serious device-related AEs than the control patients at both 2 and 5 years postoperatively. Noninferiority of the composite measure overall success was demonstrated at all follow-up intervals; superiority was demonstrated at 1 and 2 years.
Lumbar disc arthroplasty is a safe and effective treatment for single-level lumbar degenerative disc disease, resulting in improved physical function and reduced pain up to 5 years after surgery.Clinical trial registration no.: NCT00635843 (clinicaltrials.gov).

Meningiomas are the most common intracranial neoplasm. Evidence concerning surgical management and outcome is abundant, while the implications for the quality of life (QOL) of a patient confronted with the diagnosis and undergoing surgery are unclear. The authors conducted a prospective study to evaluate QOL in relation to psychological comorbidities comorbidities.
A prospective study of patients undergoing elective surgery for the removal of an intracranial meningioma was performed. The authors evaluated depression (Allgemeine Depressionsskala K score) and anxiety (Post-Traumatic Stress Scale-10 [PTSS-10]; State Trait Anxiety Inventory-State Anxiety and -Trait Anxiety [STAI-S and STAI-T]; and Anxiety Sensitivity Index-3 [ASI-3]) scores before surgery and at 3 and 12 months after surgery. The correlation between preoperative psychological burden and postoperative QOL as measured by the 36-Item Short Form Health Survey and EQ-5L questionnaires was analyzed. Incidence and influence of these psychiatric comorbidities on clinical outcome were examined.
A total of 78 patients undergoing resection of a meningioma between January 2013 and September 2017 participated in the preoperative psychological screening and 71 patients fully completed postoperative follow-up examination after 1 year of follow-up. At presentation, 48 patients (67.7%) had abnormal anxiety scores, which decreased to 29.6% (p = 0.003). On follow-up at 12 months, mean EQ-5L visual analog scale scores were significantly lower in patients with pathological scores on the PTSS-10 (0.84 vs 0.69; p = 0.004), STAI-S (0.86 vs 0.68; p = 0.001), and STAI-T (0.85 vs 0.71; p = 0.011). Neurological status (modified Rankin Scale) improved slightly and showed some correlation with psychological comorbidities QOL scores (p = 0.167). There was a nonsignificant increase of EQ-5L scores over the period of follow-up (p = 0.174) in the repeated-measures analysis. In the regression analysis, impaired QOL and physical disability on follow-up correlated with elevated preoperative anxiety and depression levels.
The QOL and physical disability of patients undergoing resection of an intracranial meningioma highly depend on preoperative anxiety and depression levels. Stress and anxiety scores generally decrease after the resection, which leads us to conclude that there is a tremendous emotional burden caused by an upcoming surgery, necessitating close psychooncological support in order to uphold functional outcome and health-related QOL in the postoperative course.

OBJECTIVE :Few studies have examined patients\' ability to drive and quality of life (QOL) after microsurgical repair for unruptured intracranial aneurysms (uIAs). However, without a strong evidentiary basis, jurisdictional road transport authorities have recommended driving restrictions following brain surgery. In the present study, authors examined the outcomes of the microsurgical repair of uIAs by measuring patients\' perceived QOL and cognitive abilities related to driving. METHODS: Between January 2011 and January 2016, patients with a new diagnosis of uIA were prospectively enrolled in this study. Assessments were performed at referral, before surgery, and at 6 weeks and 12 months after surgery in those undergoing microsurgical repair and at referral and at 12 months in conservatively managed patients. Assessments included the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the SF-36, the off-road driver-screening instrument DriveSafe (DS), the modified Barthel Index (mBI), and the modified Rankin Scale (mRS). RESULTS: One hundred sixty-nine patients were enrolled in and completed the study, and 112 (66%) of them had microsurgical repair of their aneurysm. In the microsurgical group, there was a trend for improved DS scores: from a mean (± standard deviation) score of 108 ± 10.7 before surgery to 111 ± 9.7 at 6 weeks after surgery to 112 ± 10.2 at 12 months after surgery (p = 0.05). Two percent of the microsurgical repair group and 4% of the conservatively managed group whose initial scores indicated competency to drive according to the DS test subsequently had 12-month scores deemed as not competent to drive; the difference between these 2 groups was not statistically significant (p > 0.99). Factors associated with a decline in the DS score among those who had a license at the time of initial assessment were an increasing age (p < 0.01) and mRS score > 0 at one of the assessments (initial, 6 weeks, or 12 months; p < 0.01). Mean PCS scores in the microsurgical repair group were 52 ± 8.1, 46 ± 6.8, and 52 ± 7.1 at the initial, 6-week, and 12-month assessments, respectively (p < 0.01). These values represented a significant decline in the mean PCS score at 6 weeks that recovered by 12 months (p < 0.01). There were no significant changes in the MCS, mBI, or mRS scores in the surgical group. CONCLUSIONS: Overall, QOL at 12 months for the microsurgical repair group had not decreased and was comparable to that in the conservatively managed group. Furthermore, as assessed by the DS test, the majority of patients were not affected in their ability to drive.

OBJECTIVE A multicenter, prospective, randomized equivalence trial comparing a thoracolumbosacral orthosis (TLSO) to no orthosis (NO) in the treatment of acute AO Type A3 thoracolumbar burst fractures was recently conducted and demonstrated that the two treatments following an otherwise similar management protocol are equivalent at 3 months postinjury. The purpose of the present study was to determine whether there was a difference in long-term clinical and radiographic outcomes between the patients treated with and those treated without a TLSO. Here, the authors present the 5- to 10-year outcomes (mean follow-up 7.9 ± 1.1 years) of the patients at a single site from the original multicenter trial. METHODS Between July 2002 and January 2009, a total of 96 subjects were enrolled in the primary trial and randomized to two groups: TLSO or NO. Subjects were enrolled if they had an AO Type A3 burst fracture between T-10 and L-3 within the previous 72 hours, kyphotic deformity < 35°, no neurological deficit, and an age of 16-60 years old. The present study represents a subset of those patients: 16 in the TLSO group and 20 in the NO group. The primary outcome measure was the Roland Morris Disability Questionnaire (RMDQ) score at the last 5- to 10-year follow-up. Secondary outcome measures included kyphosis, satisfaction, the Numeric Rating Scale for back pain, and the 12-Item Short-Form Health Survey (SF-12) Mental and Physical Component Summary (MCS and PCS) scores. In the original study, outcome measures were administered at admission and 2 and 6 weeks, 3 and 6 months, and 1 and 2 years after injury; in the present extended follow-up study, the outcome measures were administered 5-10 years postinjury. Treatment comparison between patients in the TLSO group and those in the NO group was performed at the latest available follow-up, and the time-weighted average treatment effect was determined using a mixed-effects model of longitudinal regression for repeated measures averaged over all time periods. Missing data were assumed to be missing at random and were replaced with a set of plausible values derived using a multiple imputation procedure. RESULTS The RMDQ score at 5-10 years postinjury was 3.6 ± 0.9 (mean ± SE) for the TLSO group and 4.8 ± 1.5 for the NO group (p = 0.486, 95% CI -2.3 to 4.8). Average kyphosis was 18.3° ± 2.2° for the TLSO group and 18.6° ± 3.8° for the NO group (p = 0.934, 95% CI -7.8 to 8.5). No differences were found between the NO and TLSO groups with time-weighted average treatment effects for RMDQ 1.9 (95% CI -1.5 to 5.2), for PCS -2.5 (95% CI -7.9 to 3.0), for MCS -1.2 (95% CI -6.7 to 4.2) and for average pain 0.9 (95% CI -0.5 to 2.2). CONCLUSIONS Compared with patients treated with a TLSO, patients treated using early mobilization without orthosis maintain similar pain relief and improvement in function for 5-10 years.

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).

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 ).

OBJECTIVE The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement. METHODS This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. Clinical outcomes at up to 60 months were evaluated, including validated outcome measures, incidence of reoperation, and adverse events. The complete study data and methodology were critically reviewed by 3 independent surgeon authors without affiliation with the IDE study or financial or institutional bias toward the study sponsor. RESULTS A total of 225 patients received the Mobi-C cervical total disc replacement device and 105 patients received ACDF. The Mobi-C and ACDF follow-up rates were 90.7% and 86.7%, respectively (p = 0.39), at 60 months. There was significant improvement in all outcome scores relative to baseline at all time points. The Mobi-C patients had significantly more improvement than ACDF patients in terms of Neck Disability Index score, SF-12 Physical Component Summary, and overall satisfaction with treatment at 60 months. The reoperation rate was significantly lower with Mobi-C (4%) versus ACDF (16%). There were no significant differences in the adverse event rate between groups. CONCLUSIONS Both cervical total disc replacement and ACDF significantly improved general and disease-specific measures compared with baseline. However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients. Clinical trial registration no. NCT00389597 ( clinicaltrials.gov ).

OBJECT This study compared the safety and efficacy of treatment with the PRESTIGE LP cervical disc versus a historical control anterior cervical discectomy and fusion (ACDF). METHODS Prospectively collected PRESTIGE LP data from 20 investigational sites were compared with data from 265 historical control ACDF patients in the initial PRESTIGE Cervical Disc IDE study. The 280 investigational patients with single-level cervical disc disease with radiculopathy and/or myelopathy underwent arthroplasty with a low-profile artificial disc. Key safety/efficacy outcomes included Neck Disability Index (NDI), Neck and Arm Pain Numerical Rating Scale scores, 36-Item Short Form Health Survey (SF-36) score, work status, disc height, range of motion, adverse events (AEs), additional surgeries, and neurological status. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Predefined Bayesian statistical methods with noninformative priors were used, along with the propensity score technique for controlling confounding factors. Analysis by independent statisticians confirmed initial statistical findings. RESULTS The investigational and control groups were mostly similar demographically. There was no significant difference in blood loss (51.0 ml [investigational] vs 57.1 ml [control]) or hospital stay (0.98 days [investigational] vs 0.95 days [control]). The investigational group had a significantly longer operative time (1.49 hours vs 1.38 hours); 95% Bayesian credible interval of the difference was 0.01-0.21 hours. Significant improvements versus preoperative in NDI, neck/arm pain, SF-36, and neurological status were achieved by 1.5 months in both groups and were sustained at 24 months. Patient follow-up at 24 months was 97.1% for the investigational group and 84.0% for the control group. The mean NDI score improvements versus preoperative exceeded 30 points in both groups at 12 and 24 months. SF-36 Mental Component Summary superiority was established (Bayesian probability 0.993). The mean SF-36 PCS scores improved by 14.3 points in the investigational group and by 11.9 points in the control group from baseline to 24 months postoperatively. Neurological success at 24 months was 93.5% in the investigational group and 83.5% in the control group (probability of superiority ~ 1.00). At 24 months, 12.1% of investigational and 15.5% of control patients had an AE classified as device or device/surgical procedure related; 14 (5.0%) investigational and 21 (7.9%) control patients had a second surgery at the index level. The median return-to-work time for the investigational group was 40 days compared with 60 days for the control group (p = 0.020 after adjusting for preoperative work status and propensity score). Following implantation of the PRESTIGE LP device, the mean angular motion was maintained at 12 months (7.9°) and 24 months (7.5°). At 24 months, 90.0% of investigational and 87.7% of control patients were satisfied with the results of surgery. PRESTIGE LP superiority on overall success (without disc height success), a composite safety/efficacy end point, was strongly supported with 0.994 Bayesian probability. CONCLUSIONS This device maintains mean postoperative segmental motion while providing the potential for biomechanical stability. Investigational patients reported significantly improved clinical outcomes compared with baseline, at least noninferior to ACDF, up to 24 months after surgery.

OBJECTIVE: The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months\' follow-up.
METHODS: A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the U.S. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery.
RESULTS: At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure.
CONCLUSIONS: Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ).

OBJECTIVE: The use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in anterior lumbar interbody fusion (ALIF) is controversial regarding the reported complication rates and cost. The authors aimed to assess the complication rates of performing ALIF using rhBMP-2.
METHODS: This is a prospective study of consecutive patients who underwent ALIF performed by a single spine surgeon and a single vascular surgeon between 2009 and 2012. All patients underwent placement of a polyetheretherketone (PEEK) cage filled with rhBMP-2 and a separate anterior titanium plate. Preoperative clinical data, operative details, postoperative complications, and clinical and radiographic outcomes were recorded for all patients. Clinical outcome measures included back and leg pain visual analog scale scores, Oswestry Disability Index (ODI), and SF-36 Physical and Mental Component Summary (PCS and MCS) scores. Radiographic assessment of fusion was performed using high-definition CT scanning. Male patients were screened pre- and postoperatively regarding sexual dysfunction, specifically retrograde ejaculation (RE).
RESULTS: The study comprised 131 patients with a mean age of 45.3 years. There were 67 men (51.1%) and 64 women (48.9%). Of the 131 patients, 117 (89.3%) underwent ALIF at L5-S1, 9 (6.9%) at L4-5, and 5 (3.8%) at both L4-5 and L5-S1. The overall complication rate was 19.1% (25 of 131), with 17 patients (13.0%) experiencing minor complications and 8 (6.1%) experiencing major complications. The mean estimated blood loss per ALIF level was 115 ml. There was 1 incidence (1.5%) of RE. No significant vascular injuries occurred. No prosthesis failure occurred with the PEEK cage and separate anterior screw-plate. Back and leg pain improved 57.2% and 61.8%, respectively. The ODI improved 54.3%, with PCS and MCS scores improving 41.7% and 21.3%, respectively. Solid interbody fusion was observed in 96.9% of patients at 12 months.
CONCLUSIONS: Anterior lumbar interbody fusion with a vascular access surgeon and spine surgeon, using a separate cage and anterior screw-plate, provides a very robust and reliable construct with low complication rates, high fusion rates, and positive clinical outcomes, and it is cost-effective. The authors did not experience the high rates of RE reported by other authors using rhBMP-2.