Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial

J Neurosurg Spine 31:508–518, 2019

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) implantrelated 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)

NuNec™ Cervical Disc Arthroplasty Improves Quality of Life in Cervical Radiculopathy and Myelopathy: A 2-Year Follow-up

Neurosurgery 83:422–428, 2018

Anterior cervical disc replacement is an alternative to fusion for the treatment of selected cases of radiculopathy andmyelopathy. We report clinical and radiological outcomes after disc replacement with the NuNec™ artificial cervical disc (Pioneer (R)  Surgical Technology, Marquette, Michigan) with subgroup analysis.

OBJECTIVE: To review clinical and radiological outcomes after anterior cervical disc replacement with the NuNec™ artificial cervical disc.

METHODS: A consecutive case series of patients undergoing cervical disc replacement with the NuNec™ artificial disc was conducted. Clinical outcomes were assessed by questionnaires preoperatively and up to 2 yr postoperatively including neck and arm pain, Neck Disability Index, Euroqol 5-dimensions, and Short Form-36; x-rays from the same period were analyzed for range of movement and presence of heterotopic ossification.

RESULTS: A total of 44 NuNec™ discs were implanted in 33 patients. Clinical improvements were seen in all outcomes; significant improvements on the Neck Disability Index, Euroqol 5-dimensions, and physical domain of the Short Form-36 were maintained at 2 yr. There was a mean of 4◦ range of movement at the replacement disc level at 2 yr, a significant reduction from baseline; there was also progression in levels of heterotopic ossification. Complications included temporary dysphagia (10%) and progression of disease requiring foraminotomy (6%); no surgery for adjacent level disease was required. There was no significant difference in the outcomes of the radiculopathy and myelopathy groups.

CONCLUSION: Clinical outcomes using the NuNec™ disc replacement are comparable with other disc replacements. Although the range of movement is reduced, the reoperation rate is very low.

Lumbar disk herniation during pregnancy: a review on general management and timing of surgery

Acta Neurochir (2018) 160:1361–1370

Objective Provide an overview of existing management strategies to suggest a guideline for surgical management of lumbar disk herniation in pregnant women based on time of presentation.

Methods We performed a narrative review on the topic using the PubMed database. A total of 63 relevant articles published after 1992 were identified, of which 17 fulfilled selection criteria.

Results A total of 22 published cases of spine surgery for disk herniation during pregnancy were found in 17 studies on the topic. Prone positioning was reported in the majority of cases during the first and early second trimester. C-sections were performed prior to spine surgery in the prone position for the majority of patients operated during the third trimester. The left lateral position with continued pregnancy was preferred during the latter half of the second trimester when delivery of the fetus cannot yet be performed but surgery is indicated.

Conclusion Spine surgery during pregnancy is a rare scenario but can be performed safely when needed if providers adhere to general guidelines. Surgical approaches and overall management are influenced by the stage of pregnancy.

Ultrasonic Total Uncinectomy

Ultrasonic Total Uncinectomy

Operative Neurosurgery 10:535–541, 2014

In standard anterior cervical diskectomy, complete resection of the uncinate process is not commonly attempted because of the risk of injury to the vertebral artery. This may result in incomplete decompression of the nerve root when there is severe osseous foraminal stenosis.

OBJECTIVE: To demonstrate the feasibility of total uncinectomy with an ultrasonic bone dissector in patients with concomitant central and foraminal stenosis requiring anterior decompression and fusion.

METHODS: A case series of patients with cervical radiculopathy or myeloradiculopathy who underwent single-level or multilevel ultrasonic total uncinectomy (UTU) in combination with anterior cervical diskectomy and fusion is presented. The uncinate process was amputated along its base with an ultrasonic bone dissector and removed en bloc to expose the cervical root and the vertebral artery. Data gathered in accordance with routine practice were analyzed retrospectively.

RESULTS: Forty-four uncinate processes were resected in 38 patients. No UTU procedures were aborted because of technical difficulties, and no vertebral artery or nerve root injury occurred. Mean follow-up was 28 weeks (range, 14-37 weeks). Mean Neck Disability Index and Visual Analog Scale scores for neck and arm pain improved from 42%, 4.9%, and 6.8% to 23%, 2.6%, and 2.1%, respectively. Postoperative computed tomography and oblique radiographs revealed complete decompression of the neural foramen after UTU.

CONCLUSION: UTU is a safe and effective technique for complete decompression of cervical nerve roots when the coexistence of central and foraminal pathology dictates an anterior approach. The surgical technique is described in detail.

Arthroplasty Versus Fusion in Single-Level Cervical Degenerative Disc Disease

Fusion

Spine 2013;38:E1096–E1107

Study Design. A systematic review of randomized controlled trials (RCTs).

Objective. To assess the effects of arthroplasty versus fusion in the treatment of radiculopathy or myelopathy, or both, due to singlelevel cervical degenerative disc disease.

Summary of Background Data. There is ongoing debate about whether fusion or arthroplasty is superior in the treatment of single-level cervical degenerative disc disease. Mainly because the intended advantage of arthroplasty compared with fusion, prevention of symptoms due to adjacent segment degeneration in the long term, is not confirmed yet. Until sufficient long-term results become available, it is important to know whether results of 1 of the 2 treatments are superior to the other in the first 1 to 2 years.

Methods. We searched electronic databases for randomized controlled trials. We included randomized controlled trials that directly compared any type of cervical fusion with any type of cervical arthroplasty, with at least 1 year of follow-up. Study selection was performed independently by 3 review authors, and “risk of bias” assessment and data extraction were independently performed by 2 review authors. In case of missing data, we contacted the study authors or the study sponsor. We assessed the quality of evidence.

Results. Nine studies (2400 participants) were included in this review; 5 of these studies had a low risk of bias. Results for the arthroplasty group were better than the fusion group for all primary comparisons, often statistically significant. For none of the primary outcomes was a clinically relevant difference in effect size shown. Quality of the evidence was low to moderate.

Conclusion. There is low to moderate quality evidence that results are consistently in favor of arthroplasty, often statistically significant. However, differences in effect size were invariably small and not clinically relevant for all primary outcomes.

Level of Evidence: 1

Prevalence, Severity, and Impact of Foraminal and Canal Stenosis Among Adults With Degenerative Scoliosis

Neurosurgery 69:1181–1187, 2011 DOI: 10.1227/NEU.0b013e31822a9aeb

Management approaches for adult scoliosis are primarily based on adults with idiopathic scoliosis and extrapolated to adults with degenerative scoliosis. However, the often substantially, but poorly defined, greater degenerative changes present in degenerative scoliosis impact the management of these patients.

OBJECTIVE: To assess the prevalence, severity, and impact of canal and foraminal stenosis in adults with degenerative scoliosis seeking operative treatment.

METHODS: A prospectively collected database of adult patients with deformity was reviewed for consecutive patients with degenerative scoliosis seeking surgical treatment, without prior corrective surgery. Patients completed the Oswestry Disability Index, SF-12, Scoliosis Research Society 22 questionnaire, and a pain numeric rating scale (0-10). Based on MRI or CT myelogram, the central canal and foraminae from T6 to S1 were graded for stenosis (normal or minimal/mild/moderate/severe).

RESULTS: Thirty-six patients were included (mean age, 68.9 years; range, 51-85). The mean leg pain numeric rating scale was 6.5, and the mean Oswestry Disability Index score was 53.2. At least 1 level of severe foraminal stenosis was identified in 97% of patients; 83% had maximum foraminal stenosis in the curve concavity. All but 1 patient reported significant radicular pain, including 78% with discrete and 19% with multiple radiculopathies. Of those with discrete radiculopathies, 76% had pain corresponding to areas of the most severe foraminal stenosis, and 24% had pain corresponding to areas of moderate stenosis.

CONCLUSION: Significant foraminal stenosis was prevalent in patients with degenerative scoliosis, and the distribution of leg pain corresponded to levels of moderate or severe foraminal stenosis. Failure to address symptomatic foraminal stenosis when surgically treating adult degenerative scoliosis may negatively impact clinical outcomes.

Long-term back pain after a single-level discectomy for radiculopathy: incidence and health care cost analysis

J Neurosurg Spine 12:178–182, 2010.(DOI: 10.3171/2009.9.SPINE09410)

Object. The most common spinal procedure performed in the US is lumbar discectomy for disc herniation. Long- term disc degeneration and height loss occur in many patients after lumbar discectomy. The incidence of mechanical back pain following discectomy varies widely in the literature, and its associated health care costs are unknown. The authors set out to determine the incidence of and the health care costs associated with mechanical back pain attributed to segmental degeneration or instability at the level of a prior discectomy performed at their institution.

Methods. The authors retrospectively reviewed the data for 111 patients who underwent primary, single-level lumbar hemilaminotomy and discectomy for radiculopathy. All diagnostic modalities, conservative therapies, and operative treatments used for the management of postdiscectomy back pain were recorded. Institutional billing and accounting records were reviewed to determine the billed costs of all diagnostic and therapeutic measures.

Results. At a mean follow-up of 37.3 months after primary discectomy, 75 patients (68%) experienced minimal to no back pain, 26 (23%) had moderate back pain requiring conservative treatment only, and 10 (9%) suffered severe back pain that required a subsequent fusion surgery at the site of the primary discectomy. The mean cost per patient for conservative treatment alone was $4696. The mean cost per patient for operative treatment was $42,554. The esti- mated cost of treatment for mechanical back pain associated with postoperative same-level degeneration or instability was $493,383 per 100 cases of first-time, single-level lumbar discectomy ($4934 per primary discectomy).

Conclusions. Postoperative mechanical back pain associated with same-level degeneration is not uncommon in patients undergoing single-level lumbar discectomy and is associated with substantial health care costs.