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Cervical disc arthroplasty: A practical review

McHugh, B; Spivak, J M
After anterior discectomy and decompression for cervical radiculopathy and myelopathy, cervical fusion has been the mainstay of treatment for decades. Ongoing investigation into cervical disc arthroplasty, with the goals of motion preservation and reduced adjacent segment degeneration, is occurring with enthusiasm. Understanding and recreating physiologic spinal motion is critical to these efforts and is an evolving process. Prospective randomized United States Food and Drug Administration regulated trials are now available for several devices with promising short-term and mid-term results. Long-term data are awaited with anticipation regarding the clinical, radiographic, and quality-based outcome measures. Ultimately, the decision to incorporate cervical disc arthroplasty into day-today practice will stem largely from the clinical outcome of the procedure, the long-term durability of the device, and the incidence of symptomatic adjacent segment degeneration, as compared with arthrodesis. 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins
EMBASE:2012398125
ISSN: 1940-7041
CID: 174154

Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of two-level lumbar degenerative disc disease: results at twenty-four months

Delamarter, Rick; Zigler, Jack E; Balderston, Richard A; Cammisa, Frank P; Goldstein, Jeffrey A; Spivak, Jeffrey M
BACKGROUND: Disc replacement arthroplasty previously has been shown to be an effective alternative to spine fusion for the treatment of single-level lumbar degenerative disc disease. The purpose of the present study was to determine the twenty-four-month results of a clinical trial of the ProDisc-L total disc replacement as compared with spinal fusion for the treatment of degenerative disc disease at two contiguous vertebral levels from L3 to S1. METHODS: A total of 237 patients were treated in a randomized controlled trial designed as a non-inferiority study for regulatory application purposes. Blocked randomization was performed with use of a 2:1 ratio of total disc arthroplasty to circumferential arthrodesis. Evaluations, including patient self-assessments, physical and neurological examinations, and radiographic examinations, were performed preoperatively, six weeks postoperatively, and three, six, twelve, eighteen, and twenty-four months postoperatively. RESULTS: At twenty-four months, 58.8% (eighty-seven) of 148 patients in the total disc replacement group were classified as a statistical success, compared with 47.8% (thirty-two) of sixty-seven patients in the arthrodesis group; non-inferiority was demonstrated. The mean Oswestry Disability Index in both groups significantly improved from baseline (p < 0.0001); the mean percentage improvement for the total disc replacement group was significantly better than that for the arthrodesis group (p = 0.0282). An established clinical criterion for success, a >/=15-point improvement in the Oswestry Disability Index from baseline, occurred in 73.2% (109) of 149 patients in the total disc replacement group and 59.7% (thirty-seven) of sixty-two patients in the arthrodesis group. The Short Form-36 physical component scores were significantly better for the total disc replacement group as compared with the arthrodesis group (p = 0.0141 at twenty-four months). Visual analog scale scores for satisfaction significantly favored total disc replacement from three to twenty-four months. At twenty-four months, 78.2% (111) of 142 patients in the total disc replacement group and 62.1% (thirty-six) of fifty-eight patients in the arthrodesis group responded "yes" when asked if they would have the same surgery again. Lumbar spine range of motion on radiographs averaged 7.8 degrees at the superior disc and 6.2 degrees at the inferior disc in patients with total disc replacement. Reduction in narcotics usage significantly favored the total disc replacement group at twenty-four months after surgery (p = 0.0020). CONCLUSIONS: Despite the relatively short duration of follow-up and design limitations, the present study suggests that two-level lumbar disc arthroplasty is an alternative to and offers clinical advantages in terms of pain relief and functional recovery in comparison with arthrodesis. Longer-term follow-up is needed to determine the risks for implant wear and/or degenerative segment changes.
PMID: 21398574
ISSN: 1535-1386
CID: 166582

Outcomes analysis of anterior-posterior fusion for low grade isthmic spondylolisthesis

Quirno, Martin; Kamerlink, Jonathan R; Goldstein, Jeffrey A; Spivak, Jeffrey M; Bendo, John A; Errico, Thomas J
BACKGROUND: Traditional surgical treatment of isthmic spondylolisthesis is posterior-lateral fusion, but the addition of anterior surgery has been explored. The purpose of this study was to evaluate the surgical and clinical outcomes of anterior-posterior surgical treatment for low-grade isthmic spondylolisthesis. METHODS: Retrospectively, we enrolled 23 consecutive patients (mean age of 50) who underwent surgical treatment for low grade isthmic spondylolisthesis. The mean follow-up was 10 months. Basic demographic and radiographic data was collected. Pre- and post-surgical clinical surveys (VAS, ODI, and SF-36) were collected. RESULTS: All 23 patients underwent anterior interbody fusion with a femoral ring allograft or ICBG in combination with posterior lumbar decompression and fusion with instrumentation. The average slip percentage decreased from 23.2% to 19.0% (p = 0.24) while slip angle increased from 9.8 degrees to 17.9 degrees (p < 0.001) and average disc height decreased from 1.9 cm to 0.80 cm (p < 0.001). VAS scores decreased from 7.1 to 2.4 (p < 0.001), ODI scores decreased from 52.5 to 28.1 (p < 0.001), and SF-36 scores increased in the Physical Component Scale (PCS) from 29.5 to 42.6 (p < 0.001). CONCLUSION: In our study, patients demonstrated an improvement in the ODI as well the physical component scores of the SF-36, thus having a good clinical outcome.
PMID: 22196389
ISSN: 1936-9719
CID: 166004

Biomechanical comparison of translaminar screw versus pedicle screw supplementation of anterior femoral ring allografts in one-level lumbar spine fusion

Razi, Afshin E; Spivak, Jeffrey M; Kummer, Frederick J; Hersh, David S; Goldstein, Jeffrey A
Pedicle screws (PS) can provide initial stabilization of anterior interbody femoral ring allograft (FRA) lumbar constructs. Translaminar screws (TLS) have also been advocated for this procedure. The objective of this study was to use an in vitro human cadaveric model to compare the stability of one-level anterior interbody lumbar constructs stabilized with PS and those stabilized with TLS. Five human cadaveric spinal motion segments (L4-S2) were biomechanically evaluated in the intact condition and using the follow- ing methods of stabilization: anterior interbody fusion with FRA, anterior FRA supplemented with PS, and anterior FRA supplemented with TLS. Stability was determined for each construct by measuring construct displacement as a function of applied load under the following conditions: compression, flexion, extension, lateral bending to each side, and axial torsion. There were no statistically significant differences in construct stability between FRA supplemented with PS and FRA supplemented with TLS under any of the loading conditions. In selected cases, supplementation of anterior femoral ring allograft with translaminar screws is a viable alternative to supplementation with pedicle screws.
PMID: 22196385
ISSN: 1936-9719
CID: 166001

The Incidence of Potential Candidates for Total Disc Replacement among Lumbar and Cervical Fusion Patient Populations

Quirno, Martin; Goldstein, Jeffrey A; Bendo, John A; Kim, Yong; Spivak, Jeffrey M
STUDY DESIGN: Retrospective chart review. PURPOSE: To evaluate the incidence of potential total disc replacement (TDR) candidates among cervical and lumbar fusion patient populations using strict Food and Drug Administration (FDA) criteria and with relative exclusion criteria removed. OVERVIEW OF LITERATURE: Recent studies suggest that the potential percentage of patients that are candidates for TDR ranges from 0-5% in lumbar fusions and 43% in cervical fusions. METHODS: We performed a retrospective chart review of 280 consecutive patients who had lumbar (n = 174) and cervical (n = 106) fusion or TDR performed by one of four independent adult orthopaedic spine surgeons. Charts were screened for investigational device exemption (IDE) inclusion/exclusion criteria and later reanalyzed excluding relative exclusion criteria, such as history of chronic medical illness, twolevel disease (cervical cases), and history of prior fusion surgery in the anatomic region. RESULTS: Of the 174 lumbar surgeries, 10 were TDR with Prodisc-L and 164 were lumbar fusions. The most common TDR exclusion criteria were lytic spondylolisthesis or spinal stenosis (47.7% of patients) and more than 2 level degenerative disc disease (37.9%). 14.9% had no IDE exclusion criteria and would be considered candidates for TDR. After excluding the relative lumbar exclusion criteria, this percentage increased to 25.8%. Of the 106 cervical cases, 3 had a TDR with Prodisc-C and 103 had a cervical fusion. Twenty eight percent had no IDE exclusion criteria and would be considered candidates for cervical TDR. CONCLUSIONS: A larger percentage of cervical fusion candidates are potential candidates for TDR (28%) than lumbar fusion candidates (14.9%) based on the strict IDE criteria
PMCID:3230648
PMID: 22164315
ISSN: 1976-7846
CID: 147694

Prospective, randomized study of surgical site infections with the use of perioperative antibiotics for 24 hours versus the duration of a drain after spinal surgery [Meeting Abstract]

Ricart-Hoffiz P.; Takemoto R.; Park J.; Andres T.; Hoelscher C.; Goldstein J.; Spivak J.; Bendo J.; Errico T.; Lonner B.
BACKGROUND CONTEXT: The use of a postoperative spinal drain for spine surgery patients is widely thought to increase the risk of postoperative infection. While antibiotics are commonly given postoperatively to decrease bacterial seeding of the hematoma, the duration of postoperative antibiotics is more debatable, and protocols may vary. PURPOSE: To determine if the continuation of postoperative antibiotics for the duration of the timea spinal drain is in place reduces the risk of acute surgical site infection, in comparison with postoperative antibiotics given for 24 hours only. STUDY DESIGN/SETTING: Prospective, randomized double-blind study. PATIENT SAMPLE: Patients undergoing multilevel thoracolumbar spine surgery in which a drain is used. OUTCOME MEASURES: Surgical site infections were defined as purulent drainage; organisms obtained from an aseptically obtained culture; pain, swelling and redness; and/or diagnosis of infection by a surgeon. METHODS: 315 patients who underwent multilevel thoracolumbar spine surgery requiring a postoperative drain were enrolled and randomized into two groups: one group receiving 24 hours of perioperative antibiotics and one group receiving antibiotics for the duration that the drain was in place. Data collected included demographics, medical co-morbidities, type of spine surgery and surgical site infection. RESULTS: 13/170 (7.6%) in the 24 hours of antibiotic group developed a surgical site infection while 21/145 (14.5%) in the antibiotic for the duration of the drain were found to have a surgical site infection. The differences between each group were significant (p<.05). There were no significant differences between the groups with respect to demographics, surgical time, type of surgery, drain output or length of stay. CONCLUSIONS: Continuing postoperative antibiotics for the entire duration a drain is in place after spine surgery does not decrease the rate of surgical site infections
EMBASE:70558137
ISSN: 1529-9430
CID: 139772

The lumbar facet joint: a review of current knowledge: Part II: diagnosis and management

Varlotta, Gerard P; Lefkowitz, Todd R; Schweitzer, Mark; Errico, Thomas J; Spivak, Jeffrey; Bendo, John A; Rybak, Leon
This article is the second article in a two-part review on lumbar facet joint pathology. In this review, we discuss the current concepts and controversies regarding the proper diagnosis and management of patients presenting with presumed facet-mediated lower back pain. All efforts were made to include the most relevant literature from the fields of radiology, orthopaedics, physiatry, and pain management. Our focus in this article is on presenting the evidence supporting or refuting the most commonly employed injection-based therapies for facet-mediated lower back pain
PMID: 20577735
ISSN: 1432-2161
CID: 116219

The prevalence of transitional vertebrae in the lumbar spine

Apazidis, Alexios; Ricart, Pedro A; Diefenbach, Christopher M; Spivak, Jeffrey M
BACKGROUND CONTEXT: Lumbosacral transitional vertebrae (LSTVs) are a congenital vertebral anomaly of the L5-S1 junction in the spine. This alteration may contribute to incorrect identification of a vertebral segment, leading to wrong-level spine surgery and poor correlation with clinical symptoms. Although several studies describe the occurrence of this anomaly in back pain populations, investigation of the prevalence in the American general population is lacking. PURPOSE: To establish the prevalence rates for LSTVs in the general population. STUDY DESIGN: Retrospective review. PATIENT SAMPLE: Consecutive kidney-urinary bladder (KUB) radiographs of subjects from the past 2 years (2008-2009). OUTCOME MEASURES: Clinical demographics, number of lumbar vertebrae, L5-S1 transverse process (TP) height, and rib length. METHODS: Consecutive adult KUB studies of adult subjects were queried with clear visibility of the last rib's vertebral body articulation, all lumbar TPs, and complete sacral wings. Exclusion criteria consisted of any radiologic evidence of previous lumbosacral surgery that would obstruct our measurements. A total of 1,100 abdominal films were reviewed, and 211 were identified as being adequate for the measurement of the desired parameters. RESULTS: Two hundred eleven subjects were identified as eligible for the study, and 75 (35.6%) were classified as positive for a transitional lumbosacral vertebra. The most common anatomical variant was the Castellvi Type IA (14.7%). The average age at the time of the KUB study was 59.8 years (18-95 years). One hundred ninety-seven subjects (93.4%) presented five lumbar (nonribbed) vertebrae, and only 14 (6.6%) had six lumbar vertebrae. CONCLUSIONS: The significance of lumbosacral transitional level changes to the establishment of pain, degenerative changes, stenosis, and disc disease have been well documented in symptomatic patients. Although LSTV's role in low back pain remains controversial, our study has shown that, when the same criteria are used for classification, prevalence among the general population and symptomatic patients may be similar
PMID: 21951610
ISSN: 1878-1632
CID: 137894

The lumbar facet joint: a review of current knowledge: part 1: anatomy, biomechanics, and grading

Varlotta, Gerard P; Lefkowitz, Todd R; Schweitzer, Mark; Errico, Thomas J; Spivak, Jeffrey; Bendo, John A; Rybak, Leon
We present a two-part review article on the current state of knowledge of lumbar facet joint pathology. This first article discusses the functional anatomy, biomechanics, and radiological grading systems currently in use in clinical practice and academic medicine. Facet joint degeneration is presented within the larger context of degenerative disc disease to enable the reader to better understand the anatomical changes underlying facet-mediated lower back pain. Other less-common, but equally important etiologies of lumbar facet joint degeneration are reviewed. The existing grading systems are discussed with specific reference to the reliability of CT and MR imaging in the diagnosis of lumbar facet osteoarthritis. It is hoped that this discussion will stimulate debate on how best to improve the diagnostic reliability of these tests so as to improve both operative and non-operative treatment outcomes
PMID: 20625896
ISSN: 1432-2161
CID: 114816

Revision of a lumbar disc arthroplasty following late infection [Case Report]

Spivak, Jeffrey M; Petrizzo, Anthony M
Anterior removal of a lumbar total disc replacement implant is often a very technically demanding procedure. The anterior retroperitoneal anatomy is prone to scarring, limiting remobilization and making a direct anterior exposure above the L5-S1 level difficult if not impossible to achieve safely. Anterolateral approach strategies can be more safely achieved at L4-L5 and above, but may require vertebral osteotomy in order to remove a keeled prosthesis. Successful conversion to a fusion with implant removal can be achieved, even when osteotomy is needed for implant removal. This Grand Rounds case presentation involves an unusual late retroperitoneal abscess following two-level TDR with direct extension to one of the implants, and the subsequent nonoperative and operative management. Removal of a well-fixed keeled implant at the L4-L5 level following nonoperative treatment of a surrounding retroperitoneal abscess and conversion to fusion represents close to, if not a 'worst-case' scenario for revision TDR. However, with proper preoperative planning and surgical experience, a safe and successful procedure can be the end result
PMCID:2899947
PMID: 19937351
ISSN: 1432-0932
CID: 109198