Biodegradable anterior cervical plates

biodegradable anterior cervical plate

J Neurosurg Spine 25:205–212, 2016

The purpose of this study was to present an initial surgical experience in the management of 1- or 2-level degenerative disc disease of the cervical spine using biodegradable anterior cervical plates (bACPs) in anterior cervical discectomy and fusion (ACDF). The authors also aimed to provide insight into this critical and controversial clinical issue by clarifying outcomes for patients receiving bACPs and by comparing their outcomes with those achieved using a traditional metallic anterior cervical plate (mACP) implant.

Methods: A retrospective review was conducted for 2 series of patients who had undergone ACDF using either bACP (31 patients, 38 segments) or mACP (47 patients, 57 segments) instrumentation. The patients were followed up for a mean 13.5 ± 0.9 months (range 12–18 months) in the bACP group and 14.8 ± 1.5 months (range 14–22 months) in the mACP group. Clinical outcomes were determined according to scores on the visual analog scale (VAS), the modified Japanese Orthopaedic Association (mJOA) scoring system, and Odom’s criteria. Radiological images were used to assess fusion rates, intervertebral height, Cobb’s angle, and the width of prevertebral soft tissue.

Results: Both VAS and mJOA scores were significantly improved at each follow-up in both groups. Excellent or good results according to Odom’s criteria were achieved in 93.5% (29/31) of patients in the bACP group and 93.6% (44/47) of patients in the mACP group. At 6 months postoperatively, the fusion rate was 94.7% (36/38) in the bACP group and 96.5% (55/57) in the mACP group, but subsidence of the intervertebral space at the surgical level was more evident in the bACP group. Angulation, as measured by Cobb’s angle, demonstrated obvious healing in both groups, while better maintenance was observed in the mACP group. The local inflammatory reaction was uneventful during follow-up. Dysphonia and dysphagia were observed in both groups during the follow-up.

Conclusions: The relatively comparable early clinical and radiographic outcomes and the overall acceptable complication rates for bACP and mACP use suggest that bACPs could be used as alternative instruments in ACDF. Mild graft resorption was noted without evidence of symptoms. However, the prospective efficacy of biodegradable instrumentation can only be elucidated with longer-term observation.

Cost Utility Analysis of the Cervical Artificial Disc vs Fusion for the Treatment of 2-Level Symptomatic Degenerative Disc Disease: 5-Year Follow-up


Neurosurgery 79:135–145, 2016

The cervical total disc replacement (cTDR) was developed to treat cervical degenerative disc disease while preserving motion.

OBJECTIVE: Cost-effectiveness of this intervention was established by looking at 2-year follow-up, and this update reevaluates our analysis over 5 years.

METHODS: Data were derived from a randomized trial of 330 patients. Data from the 12- Item Short Form Health Survey were transformed into utilities by using the SF-6D algorithm. Costs were calculated by extracting diagnosis-related group codes and then applying 2014 Medicare reimbursement rates. A Markov model evaluated qualityadjusted life years (QALYs) for both treatment groups. Univariate and multivariate sensitivity analyses were conducted to test the stability of the model. The model adopted both societal and health system perspectives and applied a 3% annual discount rate.

RESULTS: The cTDR costs $1687 more than anterior cervical discectomy and fusion (ACDF) over 5 years. In contrast, cTDR had $34 377 less productivity loss compared with ACDF. There was a significant difference in the return-to-work rate (81.6% compared with 65.4% for cTDR and ACDF, respectively; P = .029). From a societal perspective, the incremental cost-effective ratio (ICER) for cTDR was 2$165 103 per QALY. From a health system perspective, the ICER for cTDR was $8518 per QALY. In the sensitivity analysis, the ICER for cTDR remained below the US willingness-to-pay threshold of $50 000 per QALY in all scenarios (2$225 816 per QALY to $22 071 per QALY).

CONCLUSION: This study is the first to report the comparative cost-effectiveness of cTDR vs ACDF for 2-level degenerative disc disease at 5 years. The authors conclude that, because of the negative ICER, cTDR is the dominant modality.

Evaluation of spinal cord compression and hyperintense intramedullary lesions on T2-weighted sequences in patients with cervical spondylotic myelopathy using flexion-extension MRI protocol

Evaluation of spinal cord compression and hyperintense intramedullary lesions on T2-weighted sequences in patients with cervical spondylotic myelopathy using flexion-extension MRI protocol

The Spine Journal 15 (2015) 668–674

Acquired cervical stenosis is caused by the combination of disc protrusion, facet joint degeneration, hypertrophy of the ligamentum flavum, and osteophyte formation. Although these mechanical factors seem to play an important role in the pathogenesis of myelopathy, the role of dynamic factors has been suggested by many authors. Based on these results, dynamic magnetic resonance imaging (MRI) was proposed to improve diagnostic techniques in patients with cervical myelopathy.

PURPOSE: The purpose of the study was to evaluate the importance of dynamic MRI in the assessment of cervical canal stenosis and to determine the percentage of levels in which cord impingement was only visible in the extension MRI and the percentage of cases in which hyperintense intramedullary lesions (HILs) were identified only on the flexion MRI.

STUDY DESIGN: This is a retrospective case series study.

PATIENT SAMPLE: Patients with spondylotic myelopathy who had dynamic cervical MRI at our department from October 2005 to February 2007 were included.

MATERIALS AND METHODS: Fifty-one consecutive patients with spondylotic myelopathy had MRI in the neutral, flexion, and extension positions of the cervical spine.

OUTCOME MEASURES: The following entities were evaluated: canal stenosis (the evaluation of the stenosis was based on the Muhle classification) and the presence or absence of HILs.

RESULTS: Two hundred fifty-five levels were evaluated in the three positions. At each level, the stages in extension were higher than the stages in neutral and flexion positions (p<.05). From C3 to C6, around 22.5% of Stage 3 levels in the extension were Stage 1 in the neutral position. In flexion, HILs are better identified than in neutral and extension positions (p<.05). In 10% of the patients, HILs were identified only in the flexion T2-weighted sequence.

CONCLUSIONS: Extension MRI helps to identify significant cervical canal stenosis that is partially or completely absent on neutral and flexion MRI and to determine the exact number of levels to decompress surgically. Flexion MRI permits better visualization of HILs on T2-weighted sequences.

Cervical decompression and reconstruction without intraoperative neurophysiological monitoring

J Neurosurg Spine 16:107–113, 2012. DOI: 10.3171/2011.10.SPINE11199

The primary goal of this study was to review the immediate postoperative neurological function in patients surgically treated for symptomatic cervical spine disease without intraoperative neurophysiological monitoring. The secondary goal was to assess the economic impact of intraoperative monitoring (IOM) in this patient population.

Methods. This study is a retrospective review of 720 consecutively treated patients who underwent cervical spine procedures. The patients were identified and the data were collected by individuals who were not involved in their care.

Results. A total of 1534 cervical spine levels were treated in 720 patients using anterior, posterior, and combined (360°) approaches. Myelopathy was present preoperatively in 308 patients. There were 185 patients with increased signal intensity within the spinal cord on preoperative T2-weighted MR images, of whom 43 patients had no clinical evidence of myelopathy. Three patients (0.4%) exhibited a new neurological deficit postoperatively. Of these patients, 1 had a preoperative diagnosis of radiculopathy, while the other 2 were treated for myelopathy. The new postoperative deficits completely resolved in all 3 patients and did not require additional treatment. The Current Procedural Terminology (CPT) codes for IOM during cervical decompression include 95925 and 95926 for somatosensory evoked potential monitoring of the upper and lower extremities, respectively, as well as 95928 and 95929 for motor evoked potential monitoring of the upper and lower extremities. In addition to the charge for the baseline [monitoring] study, patients are charged hourly for ongoing electrophysiology testing and monitoring using the CPT code 95920. Based on these codes and assuming an average of 4 hours of monitoring time per surgical case, the savings realized in this group of patients was estimated to be $1,024,754.

Conclusions. With the continuing increase in health care costs, it is our responsibility as providers to minimize expenses when possible. This should be accomplished without compromising the quality of care to patients. This study demonstrates that decompression and reconstruction for symptomatic cervical spine disease without IOM may reduce the cost of treatment without adversely impacting patient safety.

Facetal distraction as treatment for single- and multilevel cervical spondylotic radiculopathy and myelopathy

J Neurosurg Spine 14:689–696, 2011. DOI: 10.3171/2011.2.SPINE10601
The authors discuss their successful preliminary experience with 36 cases of cervical spondylotic disease by performing facetal distraction using specially designed Goel cervical facet spacers. The clinical and radiological results of treatment are analyzed. The mechanism of action of the proposed spacers and the rationale for their use are evaluated. Between 2006 and February 2010, 36 patients were treated using the proposed technique. Of these patients, 18 had multilevel and 18 had single-level cervical spondylotic radiculopathy and/or myelopathy. The average follow-up period was 17 months with a minimum of 6 months. The Japanese Orthopaedic Association classification system, visual analog scale (neck pain and radiculopathy), and Odom criteria were used to monitor the clinical status of the patient. The patients were prospectively analyzed. The technique of surgery involved wide opening of the facet joints, denuding of articular cartilage, distraction of facets, and forced impaction of Goel cervical facet spacers into the articular cavity. Additionally, the interspinous process ligaments were resected, and corticocancellous bone graft from the iliac crest was placed and was stabilized over the adjoining laminae and facets after adequately preparing the host bone. Eighteen patients underwent single-level, 6 patients underwent 2-level, and 12 patients underwent 3-level treatment. The alterations in the physical architecture of spine and canal dimensions were evaluated before and after the placement of intrafacet joint spacers and after at least 6 months of follow-up. All patients had varying degrees of relief from symptoms of pain, radiculopathy, and myelopathy. Analysis of radiological features suggested that the distraction of facets with the spacers resulted in an increase in the intervertebral foraminal dimension (mean 2.2 mm), an increase in the height of the intervertebral disc space (range 0.4–1.2 mm), and an increase in the interspinous distance (mean 2.2 mm). The circumferential distraction resulted in reduction in the buckling of the posterior longitudinal ligament and ligamentum flavum. The procedure ultimately resulted in segmental bone fusion. No patient worsened after treatment. There was no noticeable implant malfunction. During the follow-up period, all patients had evidence of segmental bone fusion. No patient underwent reexploration or further surgery of the neck. Distraction of the facets of the cervical vertebra can lead to remarkable and immediate stabilization-fixation of the spinal segment and increase in space for the spinal cord and roots. The procedure results in reversal of several pathological events related to spondylotic disease. The safe, firm, and secure stabilization at the fulcrum of cervical spinal movements provided a ground for segmental spinal arthrodesis. The immediate postoperative improvement and lasting recovery from symptoms suggest the validity of the procedure.

Cervical spondylotic myelopathy associated with kyphosis or sagittal sigmoid alignment: outcome after anterior or posterior decompression

J Neurosurg Spine 11:521–528, 2009. DOI: 10.3171/2009.2.SPINE08385

The effects of sagittal kyphotic deformities or mechanical stress on the development of cervical spondylotic myelopathy, or the reduction and fusion of kyphotic sagittal alignment have not been consistently documented. The aim in this study was to determine the effects of kyphotic sagittal alignment of the cervical spine in terms of neurological morbidity and outcome after 2 types of surgical intervention.

Methods. The authors retrospectively reviewed the records of 476 patients who underwent cervical spine surgeries for spondylotic myelopathy between 1993 and 2006 at their university medical center. Among these were identified 43 patients—30 men and 13 women, with a mean age of 58.8 years—who had cervical kyphosis exceeding 10° on preoperative sagittal lateral radiographs obtained in the neutral position, and their cases were analyzed in this study. Anterior decompression with interbody fusion was conducted in 28 patients, and en bloc open-door C3–7 laminoplasty in 15 patients. Both pre- and postoperative neurological, radiographic, and MR imaging findings were assessed in both surgical groups.

Results. The mean preoperative kyphotic angle in all 43 patients was 15.9 ± 5.9° in the neutral position. Seg- mental instability was noted in 26 patients (61%) and reversed dynamic spinal canal stenosis at the level above the local kyphosis in 22 (51%). Preoperative T2-weighted MR images showed high-intensity signal within the cord at and around the level of maximal compression or segmental instability in 28 patients (65%). The mean kyphotic angle in both the neutral and flexion positions was significantly smaller at 4–6 weeks after surgery in the anterior spondylectomy group than in the laminoplasty group (p < 0.001). Furthermore, the angle in the neutral position was significantly smaller on follow-up in the anterior spondylectomy group than in the laminoplasty group (p = 0.034). The transverse area of the spinal cord was significantly larger in the anterior spondylectomy group than in the lamino- plasty group on follow-up (p = 0.037). Preoperative neurological scores (assessed using the Japanese Orthopaedic Association scale) and improvement on follow-up ≥ 2 years after treatment (average 3.3 years) were not significantly different between the 2 groups; however, there was a significant difference in Japanese Orthopaedic Association score at 4–6 weeks postoperatively (p = 0.047).

Conclusions. Kyphotic deformity and mechanical stress in the cervical spine may play an important role in neurological dysfunction. In a select group of patients with kyphotic deformity ≥ 10°, adequate correction of local sagittal alignment may help to maximize the chance of neurological improvement

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