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Comparative charge analysis of one- and two-level lumbar total disc arthroplasty versus circumferential lumbar fusion

Levin, David A; Bendo, John A; Quirno, Martin; Errico, Thomas; Goldstein, Jeffrey; Spivak, Jeffrey
STUDY DESIGN: This is a retrospective, independent study comparing 2 groups of patients treated surgically for discogenic low back pain associated with degenerative disc disease (DDD) in the lumbosacral spine. OBJECTIVE: To compare the surgical and hospitalization charges associated with 1- and 2-level lumbar total disc replacement and circumferential lumbar fusion. SUMMARY OF BACKGROUND DATA: Reported series of lumbar total disc replacement have been favorable. However, economic aspects of lumbar total disc replacement (TDR) have not been published or studied. This information is important considering the recent widespread utilization of new technologies. Recent studies have demonstrated comparable short-term clinical results between TDR and lumbar fusion recipients. Relative charges may be another important indicator of the most appropriate procedure. We report a hospital charge-analysis comparing ProDisc lumbar disc replacement with circumferential fusion for discogenic low back pain. METHODS: In a cohort of 53 prospectively selected patients with severe, disabling back pain and lumbar disc degeneration, 36 received Synthes ProDisc TDR and 17 underwent circumferential fusion for 1- and 2-level degenerative disc disease between L3 and S1. Randomization was performed using a 2-to-1 ratio of ProDisc recipients to control spinal fusion recipients. Charge comparisons, including operating room charges, inpatient hospital charges, and implant charges, were made from hospital records using inflation-corrected 2006 U.S. dollars. Operating room times, estimated blood loss, and length of stay were obtained from hospital records as well. Surgeon and anesthesiologist fees were, for the purposes of comparison, based on Medicare reimbursement rates. Statistical analysis was performed using a 2-tailed Student t test. RESULTS: For patients with 1-level disease, significant differences were noted between the TDR and fusion control group. The mean total charge for the TDR group was $35,592 versus $46,280 for the fusion group (P = 0.0018). Operating room charges were $12,000 and $18,950, respectively, for the TDR and fusion groups (P < 0.05). Implant charges averaged $13,990 for the fusion group, which is slightly higher than the $13,800 for the ProDisc (P = 0.9). Estimated blood loss averaged 794 mL in the fusion group versus 412 mL in the TDR group (P = 0.0058). Mean OR minutes averaged 344 minutes for the fusion group and 185 minutes for the TDR (P < 0.05) Mean length of stay was 4.78 days for fusion versus 4.32 days for TDR (P = 0.394). For patients with 2-level disease, charges were similar between the TDR and fusion groups. The mean total charge for the 2-level TDR group was $55,524 versus $56,823 for the fusion group (P = 0.55). Operating room charges were $15,340 and $20,560, respectively, for the TDR and fusion groups (P = 0.0003). Surgeon fees and anesthesiologist charges based on Medicare reimbursement rates were $5857 and $525 for the fusion group, respectively, versus $2826 and $331 for the TDR group (P < 0.05 for each). Implant charges were significantly lower for the fusion group (mean, $18,460) than those for 2-level Synthes ProDisc ($27,600) (P < 0.05). Operative time averaged 387 minutes for fusion versus 242 minutes for TDR (P < 0.0001). EBL and length of stay were similar. CONCLUSION: Patients undergoing 1- and 2-level ProDisc total disc replacement spent significantly less time in the OR and had less EBL than controls. Charges were significantly lower for TDR compared with circumferential fusions in the 1-level patient group, while charges were similar in the 2-level group
PMID: 18246016
ISSN: 1528-1159
CID: 75860

Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease

Zigler, Jack; Delamarter, Rick; Spivak, Jeffrey M; Linovitz, Raymond J; Danielson, Guy O 3rd; Haider, Thomas T; Cammisa, Frank; Zuchermann, Jim; Balderston, Richard; Kitchel, Scott; Foley, Kevin; Watkins, Robert; Bradford, David; Yue, James; Yuan, Hansen; Herkowitz, Harry; Geiger, Doug; Bendo, John; Peppers, Timothy; Sachs, Barton; Girardi, Federico; Kropf, Michael; Goldstein, Jeff
STUDY DESIGN: A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial. OBJECTIVE: To evaluate the safety and effectiveness of the ProDisc-L (Synthes Spine, West Chester, PA) lumbar total disc replacement compared to circumferential spinal fusion for the treatment of discogenic pain at 1 vertebral level between L3 and S1. SUMMARY OF BACKGROUND DATA: As part of the Investigational Device Exemption clinical trial, favorable single center results of lumbar total disc replacement with the ProDisc-L have been reported previously. METHODS: Two hundred eighty-six (286) patients were treated on protocol. Patients were evaluated before and after surgery, at 6 weeks, 3, 6, 12, 18, and 24 months. Evaluation at each visit included patient self-assessments, physical and neurologic examinations, and radiographic evaluation. RESULTS: Safety of ProDisc-L implantation was demonstrated with 0% major complications. At 24 months, 91.8% of investigational and 84.5% of control patients reported improvement in the Oswestry Low Back Pain Disability Questionnaire (Oswestry Disability Index [ODI]) from preoperative levels, and 77.2% of investigational and 64.8% of control patients met the > or =15% Oswestry Disability Index improvement criteria. Overall neurologic success in the investigational group was superior to the control group (91.2% investigational and 81.4% control; P = 0.0341). At 6 weeks and 3 months follow-up time points, the ProDisc-L patients recorded SF-36 Health Survey scores significantly higher than the control group (P = 0.018, P = 0.0036, respectively). The visual analog scale pain assessment showed statistically significant improvement from preoperative levels regardless of treatment (P < 0.0001). Visual analog scale patient satisfaction at 24 months showed a statistically significant difference favoring investigational patients over the control group (P = 0.015). Radiographic range of motion was maintained within a normal functional range in 93.7% of investigational patients and averaged 7.7 degrees. CONCLUSIONS: ProDisc-L has been found to be safe and efficacious. In properly chosen patients, ProDisc-L has been shown to be superior to circumferential fusion by multiple clinical criteria
PMID: 17495770
ISSN: 1528-1159
CID: 94852

Laminoplasty: a review of its role in compressive cervical myelopathy

Hale, James J; Gruson, Konrad I; Spivak, Jeffrey M
BACKGROUND CONTEXT: The currently accepted surgical treatments for compressive cervical myelopathy include both anterior and posterior decompression. Anterior approaches including multilevel discectomy with fusion or vertebral corpectomy with strut grafting, both with and without instrumentation, have enjoyed successful outcomes, but have been associated with select postoperative complications. Laminoplasty has been developed to decompress the spine posteriorly while avoiding the spinal destabilization seen after laminectomy. PURPOSE: The purpose of this article is to provide a review of the various techniques, biomechanical basis, predictive value of imaging modalities, clinical outcomes, and postoperative complications associated with cervical laminoplasty. STUDY DESIGN: A review of the literature. METHODS: A comprehensive literature review using Medline was performed identifying relevant articles that addressed the techniques, clinical outcomes, and complications after cervical laminoplasty, as well as preoperative radiographic predictors of outcome. RESULTS: The various modifications of cervical laminoplasty have generally been associated with excellent clinical outcomes when used for myelopathy secondary to cervical spondylosis or ossification of the posterior longitudinal ligament (OPLL). Recent long-term studies have identified issues with this technique including axial neck pain, canal restenosis, nerve root palsy, diminished cervical motion, and loss of cervical lordotic alignment. CONCLUSIONS: Cervical laminoplasty remains a reliable procedure for posterior decompression of the spine, but the optimal approach to cervical myelopathy must take into account both patient and disease characteristics, as well as the capabilities and experience of the surgeon
PMID: 17097549
ISSN: 1529-9430
CID: 71861

Embryology of the spine and associated congenital abnormalities

Kaplan, Kevin M; Spivak, Jeffrey M; Bendo, John A
BACKGROUND CONTEXT: The spine is a complex and vital structure. Its function includes not only structural support of the body as a whole, but it also serves as a conduit for safe passage of the neural elements while allowing proper interaction with the brain. Anatomically, a variety of tissue types are represented in the spine. Embryologically, a detailed cascade of events must occur to result in the proper formation of both the musculoskeletal and neural elements of the spine. Alterations in these embryologic steps can result in one or more congenital abnormalities of the spine. Other body systems forming at the same time embryologically can be affected as well, resulting in associated defects in the cardiopulmonary system and the gastrointestinal and genitourinary tracts. PURPOSE: This article is to serve as a review of the basic embryonic development of the spine. We will discuss the common congenital anomalies of the spine, including their clinical presentation, as examples of errors of this basic embryologic process. STUDY DESIGN/SETTING: Review of the current literature on the embryology of the spine and associated congenital abnormalities. METHODS: A literature search was performed on the embryology of the spine and associated congenital abnormalities. RESULTS: Development of the spine is a complex event involving genes, signaling pathways and numerous metabolic processes. Various abnormalities are associated with errors in this process. CONCLUSION: Physicians treating patients with congenital spinal deformities should have an understanding of normal embryologic development as well as common associated abnormalities
PMID: 16153587
ISSN: 1529-9430
CID: 61843

Percutaneous treatment of vertebral body pathology

Spivak, Jeffrey M; Johnson, Michael G
Percutaneous vertebral body injection procedures currently are used to stabilize and reinforce weakened or fractured bone resulting from metastatic disease and severe osteoporosis. Both vertebroplasty and kyphoplasty can reinforce the structure of a vertebral body and provide pain relief, but the procedures have technical differences. Kyphoplasty improves vertebral height to varying degrees in nearly three quarters of patients. Kyphosis is improved more effectively when the procedure is performed within 3 months from the onset of fracture pain. To date, it is unknown whether vertebroplasty with preprocedure postural reduction can provide similar improvement of deformity. Complications are relatively infrequent with both vertebroplasty and kyphoplasty. Cement leakage from the vertebral body is more likely with vertebroplasty than with kyphoplasty. Leakage is more common in the treatment of pathologic fractures resulting from metastatic disease. Clinical complications caused by cement leakage and neural compression are infrequent. Specific indications for these injection procedures need to be more clearly refined. Long-term outcomes, including the fate of the injected material and the effect on adjacent vertebrae, have yet to be determined
PMID: 15712978
ISSN: 1067-151x
CID: 55602

Degenerative lumbar spinal stenosis: options for aging backs

Chen, Andrew L; Spivak, Jeffrey M
Degenerative lumbar spinal stenosis commonly disables and functionally limits the aging population. Degenerative changes may constrict the spinal canal, lateral recesses, and neural foramina, compressing the neural elements. Clinicians can make an earlier, more accurate diagnosis by using advanced imaging techniques. Nonoperative management is the mainstay of treatment, although surgery is indicated in patients who have progressive neurologic decline or when nonoperative measures have failed to adequately address symptoms
PMID: 20086483
ISSN: 0091-3847
CID: 106288

Somatosensory evoked potential monitoring of lumbar pedicle screw placement for in situ posterior spinal fusion [Case Report]

Gundanna, Mukund; Eskenazi, Mark; Bendo, John; Spivak, Jeffrey; Moskovich, Ronald
BACKGROUND CONTEXT: Somatosensory evoked potentials (SSEP) are commonly used to monitor the spinal cord and nerve roots during operative procedures that put those structures at risk. The utility of SSEPs to evaluate cauda equina and nerve root function during posterior spinal arthrodesis with pedicular fixation for degenerative lumbar disease has been reported anecdotally and remains controversial. PURPOSE: An institution-wide review of the ability of SSEP readings to monitor nerve function during posterior lumbar spinal arthrodeses with transpedicular fixation for degenerative lumbar spinal disorders was undertaken. STUDY DESIGN/SETTING: A retrospective review was undertaken. Patient history, preoperative physical examination, intraoperative anesthesia, SSEP records and the postoperative course were reviewed. METHODS: A total of 186 consecutive arthrodeses as described above were reviewed. Patients who had anterior procedures, spondyloreduction or scoliosis correction were excluded from the study. There were 76 male and 110 female patients. Five fellowship-trained spine surgeons placed a total of 888 pedicle screws. Sixty-five percent of the patients had a principal preoperative diagnosis of spinal stenosis with degenerative spondylolisthesis. Other common diagnoses were isthmic spondylolisthesis and degenerative scoliosis. Ninety-three percent of the cases involved decompressive laminectomy. Eight percent had posterior interbody fusions. All pedicle screws were placed without the assistance of fluoroscopy or stereotactic computer-assisted guidance. Screw position was evaluated intraoperatively with standard posteroanterior and lateral radiographs.Anesthetic agents compatible with SSEP monitoring were used in all patients. SSEP baseline readings were obtained in all patients in the operating room soon after induction of general anesthesia. An acute and sustained loss of 50% of the SSEP amplitude and/or increase by 10% of latency from baseline was considered to be pathologic. RESULTS: None of the 186 patients had significant SSEP changes. There were, however, 5 patients with postoperative radiculopathies distinct from their preoperative presentations. Early postoperative plain radiographs and computed assisted tomography (CAT) scans revealed malpositioned pedicle screws. Consequently, eight pedicle screws were either revised or removed. All patients had partial or full recovery of their new deficits after revision surgery. CONCLUSION: We conclude that the use of SSEPs in evaluating pedicle screw placement during lumbar arthrodesis is limited. In this setting, if monitoring is required, alternative methods with greater sensitivity and efficacy should be explored
PMID: 14588949
ISSN: 1529-9430
CID: 42647

Vertebroplasty: weighing the benefits and the risks [Editorial]

Spivak, Jeffrey M
PMID: 12201550
ISSN: 0002-838x
CID: 94853

Internal fixation of thoracolumbar injuries

Hasharoni, A; Spivak, JM
SCOPUS:0036967474
ISSN: 1040-7383
CID: 564102

Augmentation of anterior vertebral body screw fixation by an injectable, biodegradable calcium phosphate bone substitute

Bai B; Kummer FJ; Spivak J
STUDY DESIGN: A biomechanical study to evaluate the effects of a biodegradable calcium phosphate (Ca-P) bone substitute on the fixation strength and bending rigidity of vertebral body screws. OBJECTIVES: To determine if an injectable, biodegradable Ca-P bone substitute provides significant augmentation of anterior vertebral screw fixation in the osteoporotic spine. SUMMARY OF BACKGROUND DATA: Polymethylmethacrylate (PMMA) augmented screws have been used clinically; however, there is concern about thermal damage to the neural elements during polymerization of the PMMA as well as its negative effects on bone remodeling. Injectable, biodegradable Ca-P bone substitutes have shown enhanced fixation of pedicle screws. METHODS: Sixteen fresh cadaveric thoracolumbar vertebrae were randomly divided into two groups: control (no augmentation) (n = 8) and Ca-P bone substitute augmentation (n = 8) groups. Bone-screw fixation rigidity in bending was determined initially and after 10(5) cycles, followed by pullout testing of the screw to failure to determine pullout strength and stiffness. RESULTS: The bone-screw bending rigidity for the Ca-P bone substitute group was significantly greater than the control group, initially (58%) and after cyclic loading (125%). The pullout strength for Ca-P bone substitute group (1848 +/- 166 N) was significantly greater than the control group (665 +/- 92 N) (P < 0.01). Stiffness in pullout for the Ca-P bone substitute groups (399 +/- 69 N/mm) was significantly higher than the control group (210 +/- 51 N/mm) (P < 0.01). CONCLUSION: This study demonstrated that augmentation of anterior vertebral body screw fixation with a biodegradable Ca-P bone substitute is a potential alternative to the use of PMMA cement
PMID: 11740354
ISSN: 0362-2436
CID: 65808