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Persistent pain after spine arthroplasty: lumbar disc replacement
Chapter by: Stieber, JR; Goldstein, J
in: Motion preservation surgery of the spine : advanced techniques and controversies by Yue, James J (Ed)
Philadelphia, PA : Saunders/Elsevier, 2008
pp. ?-?
ISBN: 1416039945
CID: 4304832
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
What is your diagnosis? Erythema Ab igne [Case Report]
Warycha, Melanie; Goldstein, Jeffrey; Hale, James J
PMID: 17243424
ISSN: 0011-4162
CID: 1606362
Transcatheter repair of recurrent postinfarct ventricular septal defects
Shah, Nirav R; Goldstein, Jeffrey A; Balzer, David T; Lasala, John M; Moazami, Nader
Surgical repair of recurrent postmyocardial infarction septal defect is associated with a high mortality rate. We present 2 patients whose recurrent defects were closed percutaneously using an Amplatzer device
PMID: 16242481
ISSN: 1552-6259
CID: 116484
Toe flexor forces in dancers and non-dancers
Nihal, Aneel; Goldstein, Jeffrey; Haas, Judith; Hiebert, Rudi; Kummer, Frederick J; Liederbach, Marijeanne; Trepman, Elly
Toe flexor force (hallux and second toe) was determined in the right and left feet of 24 dancers and 29 non-dancers (sitting and standing positions) using a commercially-available pressure sensor connected to a voltmeter. For the hallux and second toe combined (all trials combined), average toe flexor force was slightly greater for dancers than non-dancers (dancers, 7 +/- 4 N; non-dancers, 6 +/- 4 N; P<0.049). For dancers and non-dancers combined (all trials), the average toe flexor force of the hallux was more than twice that of the second toe (hallux, 9 +/- 4 N; 2nd toe, 4 +/- 1 N; P<0.0001); average toe flexor force was slightly greater in standing than sitting positions (standing, 7 +/- 4 N; sitting, 6 +/- 3 N; P<0.0001); and the average toe flexor force was slightly greater for the right than left foot (right, 7 +/- 4 N; left, 6 +/- 4 N; P<0.012). The average toe flexor force was greatest for the first repetition and slightly decreased for the second and third repetitions (first repetition, 7 +/- 4 N; second and third repetitions each, 6 +/- 4 N; P<0.0013). Toe flexor force measurement may potentially be applicable to clinical practice as a guide to rehabilitation after injury or as a screening parameter for readiness to advance dance or other athletic training, performance, or competition
PMID: 12503803
ISSN: 1071-1007
CID: 65806
Lumbar sagittal alignment after fusion with a threaded interbody cage
Goldstein JA; Macenski MJ; Griffith SL; McAfee PC
STUDY DESIGN: Records of 111 patients randomly selected from a population who received an interbody fusion cage during a clinical Investigation Device Exemption trial (BAK/L) yielded 126 operative levels and were retrospectively assessed. OBJECTIVES: This study examined lumbar spine sagittal alignment and clinical outcomes before and 2 years after fusion surgery. SUMMARY OF BACKGROUND DATA: Lumbar lordosis is important in spinal sagittal alignment and balance, especially the L4-S1 area. Perceived consensus is that anatomically correct lumbar lordosis is desired and that a loss of lumbar lordosis may lead to spine pathology. There is little information on lumbar lordosis after interbody fusion. METHODS: A random sample of 111 patients who received a cylindrical cage implant (total pool of 947 patients) yielded 126 operative lumbar segments. There were 52 posterior approaches and 59 anterior approaches, and all cages were placed in the L4-L5 or L5-S1 levels. Preoperative and 2-year follow-up lateral radiographs were measured for segmental lordosis. Cage position was measured relative to the posterior longitudinal ligament. Segmental lordotic change was correlated to clinical outcome at the 2-year follow-up. RESULTS: Preoperative lordosis was different as a function of surgical approach. There was a significant 2-year decrease in lordosis with the posterior approach group; however, all intervertebral angles were within typical ranges. Clinical outcomes were significantly improved 2 years postsurgery. There was no correlation between changes in lordosis and clinical outcomes. CONCLUSIONS: Interbody lumbar fusion with a threaded cylindrical cage does not appear to have any clinically relevant effects on segmental lordosis, which is maintained within anatomically normal levels. Clinical outcome measures show significant postsurgery improvement, and changes in lordotic angles are not predictive of clinical outcome
PMID: 11413426
ISSN: 0362-2436
CID: 26736
Salter-Harris III stress fracture of the proximal first metatarsal: a case report [Case Report]
Kadel, N J; Goldstein, J; Newberg, A H; Trepman, E
An intraarticular, dorsal, proximal epiphyseal stress fracture (Salter-Harris III) of the first metatarsal was identified in a 14-year-old boy. Successful fracture healing was achieved with a rocker sole shoe modification and activity limitation.
PMID: 11310869
ISSN: 1071-1007
CID: 3886912
The ACL-deficient knee: natural history and treatment options
Goldstein J; Bosco JA 3rd
Injury to the anterior cruciate ligament removes the major stabilizing structure to anterior tibial translation. The initial trauma may lead to meniscal and cartilage damage, predisposing the knee to early degenerative changes. Moreover, a knee with an isolated ACL rupture may have recurrent episodes of instability that can lead to a similar degenerative course. At this time, one cannot accurately predict which patients will tolerate ACL deficiency, and which patients will not. Current long-term studies support a progressive worsening condition in the ACL and meniscal deficient knees. Physical therapy together with lifestyle modifications may be necessary. Those unwilling to make these types of changes or those with associated injuries may benefit from ACL reconstruction
PMID: 12102406
ISSN: 0018-5647
CID: 36202
Molecular pathogenesis in sporadic head and neck paraganglioma
Bikhazi, P H; Messina, L; Mhatre, A N; Goldstein, J A; Lalwani, A K
HYPOTHESIS: Similar to familial tumors, sporadic head and neck paragangliomas are associated with chromosomal deletions at either 11q13 or 11q22-23. BACKGROUND: Familial paragangliomas are inherited in an autosomal dominant pattern with genomic imprinting of the maternal allele. Genetic studies of familial paragangliomas have localized the causative genetic defect to two separate loci: 11q13.1 and 11q22-23. The molecular pathogenesis of sporadic head and neck paragangliomas has not been studied. METHODS: Blood and tumor samples from patients with sporadic head and neck paragangliomas were screened for deletions on chromosome 11 using DNA microsatellite markers and polymerase chain reaction. Polymerase chain reaction-amplified alleles from tumor specimens were compared with those from the blood of eight patients. A greater than 50% reduction in band intensity (as determined by densitometric analysis) between blood and tumor sample was indicative of a chromosomal deletion. RESULTS: Three of the eight patients were found to have deletions at chromosome 11q: two at chromosome 11q22-23 and one at 11q13. CONCLUSIONS: Sporadic head and neck paragangliomas are associated with deletions at chromosome 11q13 and 11q22-23. It is thus likely that sporadic and familial paragangliomas share a similar molecular pathogenesis.
PMID: 10942138
ISSN: 0023-852x
CID: 789332