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Zigler J.E.,The Texas Institute | Glenn J.,Core Orthopaedic Medical Center | Delamarter R.B.,Cedars Sinai Spine Center
Journal of Neurosurgery: Spine

Object. The authors report the 5-year results for radiographically demonstrated adjacent-level degenerative changes from a prospective multicenter study in which patients were randomized to either total disc replacement (TDR) or circumferential fusion for single-level lumbar degenerative disc disease (DDD). Methods. Two hundred thirty-six patients with single-level lumbar DDD were enrolled and randomly assigned to 2 treatment groups: 161 patients in the TDR group were treated using the ProDisc-L (Synthes Spine, Inc.), and 75 patients were treated with circumferential fusion. Radiographic follow-up data 5 years after treatment were available for 123 TDR patients and 43 fusion patients. To characterize adjacent-level degeneration (ALD), radiologists at an independent facility read the radiographic films. Adjacent-level degeneration was characterized by a composite score including disc height loss, endplate sclerosis, osteophytes, and spondylolisthesis. At 5 years, changes in ALD (ΔALDs) compared with the preoperative assessment were reported. Results. Changes in ALD at 5 years were observed in 9.2% of TDR patients and 28.6% of fusion patients (p = 0.004). Among the patients without adjacent-level disease preoperatively, new findings of ALD at 5 years posttreatment were apparent in only 6.7% of TDR patients and 23.8% of fusion patients (p = 0.008). Adjacent-level surgery leading to secondary surgery was reported for 1.9% of TDR patients and 4.0% of fusion patients (p = 0.6819). The TDR patients had a mean preoperative index-level range of motion ([ROM] of 7.3° ) that decreased slightly (to 6.0° ) at 5 years after treatment (p = 0.0198). Neither treatment group had significant changes in either ROM or translation at the superior adjacent level at 5 years posttreatment compared with baseline. Conclusions. At 5 years after the index surgery, ProDisc-L maintained ROM and was associated with a significantly lower rate of ΔALDs than in the patients treated with circumferential fusion. In fact, the fusion patients were greater than 3 times more likely to experience ΔALDs than were the TDR patients. Clinical trial registration no.: NCT00295009. Source

Zigler J.E.,The Texas Institute | Delamarter R.,Cedars Sinai Spine Center | Murrey D.,Ortho Carolina Spine Center | Spivak J.,New York University | Janssen M.,Spinal USA

STUDY DESIGN.: Randomized controlled trial. OBJECTIVE.: Analyze the clinical outcomes at 5 years comparing cervical total disc replacement (TDR) with ProDisc-C (Synthes Spine USA Products; LLC, West Chester, PA) with anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA.: Previous reports of 2- and 4-year results have shown that ProDisc-C, a TDR for surgical treatment of patients experiencing single-level symptomatic cervical disc disease between C3 and C7, is safe and effective. METHODS.: Two hundred nine patients (103 ProDisc-C and 106 ACDF) from 13 sites were randomized and treated. Results including neck disability index, visual analog scale (VAS) neck and arm pain, Short Form-36 (SF-36), neurological examination, device success, adverse event occurrence, and VAS patient satisfaction were analyzed. RESULTS.: Demographics were similar between the 2 patient groups (ProDisc-C: 42.1 ± 8.4 yr, 44.7% males; ACDF: 43.5 ± 7.1 yr, 46.2% males). Rates of follow-up at 2 years were 98.1% ProDisc-C and 94.8% ACDF, and at 5 years 72.7% ProDisc-C and 63.5% ACDF. For all clinical outcomes for both groups, there was a statistically and clinically significant improvement at 2 and 5 years compared with baseline. At 5 years, ProDisc-C patients had statistically significantly less neck pain intensity and frequency. Both groups scored high VAS satisfaction scores at 5 years, with ProDisc-C 86.56 and ACDF 82.74. There were no reports of device failures or implant migration with ProDisc-C. The ProDisc-C patients maintained motion at their index level. At 5 years, the ProDisc-C patients had a statistically significantly lower rate of reoperation compared with ACDF patients (2.9% vs. 11.3%). CONCLUSION.: Five-year results show that TDR with ProDisc-C is a safe and effective treatment of single-level symptomatic cervical disc disease. Clinical outcomes were comparable with ACDF. ProDisc-C patients maintained motion at the index level and had significantly less neck pain intensity and frequency as well as a lower probability of secondary surgery. © 2013, Lippincott Williams & Wilkins. Source

BACKGROUND:: Traditional surgical options for the treatment of symptomatic lumbar spinal stenosis include decompression alone vs decompression and fusion; both options have potential limitations. OBJECTIVE:: To report the 36-month follow-up analysis of the coflex Interlaminar Stabilization (Paradigm Spine, LLC, New York, New York) after decompression, examined under a Food and Drug Administration investigational device exemption clinical trial, which is intended to provide stabilization after decompression while preserving normal segmental motion at the treated level. METHODS:: The coflex trial was a prospective, randomized investigational device exemption study conducted at 21 clinical sites in the United States. Baseline and follow-up visits collected demographics, clinical, and radiographic status. The primary endpoint was a measure of composite clinical success 24 months postoperatively. For this current 36-month analysis, composite clinical success was calculated using analogous methods. RESULTS:: Composite clinical success at 36 months was achieved by 62.2% among 196 coflex Interlaminar Stabilization patients and 48.9% among 94 fusion patients (difference = 13.3%, 95% confidence interval, 1.1%-25.5%, P = .03). Bayesian posterior probabilities for noninferiority (margin = −10%) and superiority of coflex Interlaminar Stabilization vs fusion were >0.999 and 0.984, respectively. Substantial and comparable improvements were observed in both groups for patient-reported outcomes, although the percentage with a clinically significant improvement (≥15) in the Oswestry Disability Index seemed larger for the coflex Interlaminar Stabilization group relative to the fusion group (P = .008). Radiographic measurements maintained index level and adjacent level range of motion in coflex Interlaminar Stabilization patients, although range of motion at the level superior to fusion was significantly increased (P = .005). CONCLUSION:: Coflex Interlaminar Stabilization for stenosis is proven to be effective and durable at improving overall composite clinical success without altering normal spinal kinematic motion at the index level of decompression or adjacent levels. ABBREVIATIONS:: CCS, composite clinical successCEC, clinical events committeeFDA, Food and Drug AdministrationIDE, investigational device exemptionILS, Coflex Interlaminar StabilizationODI, Oswestry Disability IndexSF-12, Short-Form 12VAS, visual analogue scalesZCQ, Zurich Claudication Questionnaire Copyright © by the Congress of Neurological Surgeons Source

Qureshi S.,Mount Sinai Medical Center | Goz V.,Mount Sinai Medical Center | McAnany S.,Mount Sinai Medical Center | Cho S.K.,Mount Sinai Medical Center | And 3 more authors.
Journal of Neurosurgery: Spine

Object. Cost-effectiveness analysis (CEA) of medical interventions has become increasingly relevant to the discussion of optimization of care. The use of utility scales in CEA permits a quantitative assessment of effectiveness of a given intervention. There are no published utility values for degenerative disc disease (DDD) of the cervical spine, anterior cervical discectomy and fusion (ACDF), or cervical disc replacement (CDR). The purpose of this study was to define health utility values for those health states. Methods. The 36-Item Short Form Health Survey data from the ProDisc-C investigational device exemption study were obtained for single-level DDD at baseline and 24 months postoperatively after ACDF or CDR procedures. Patients in the original study were randomized to either ACDF or CDR. Utilizing a commercially available Short Form-6 dimensions program, utility scores were calculated for each health state using a set of parametric preference weights obtained from a sample of the general population using the recognized valuation technique of standard gamble. Results. The baseline health state utility (HSU) value for a patient with single-level DDD was 0.54 in both the ACDF and CDR groups. Postoperative changes in HSU values were seen in both intervention groups at 24 months. Cervical disc replacement had a HSU value of 0.72. Anterior cervical discectomy and fusion was found to have a postoperative utility state of 0.71. No statistically significant difference was found in the HSU for ACDF and CDR at 24 months of follow-up. Conclusions. This study represents the first calculated HSU value for a patient with single-level cervical DDD. Additionally, 2 common treatment interventions for this disease state were assessed. Both treatments were found to have significant impact on the HSU values. These values are integral to future CEA of ACDF and CDR. ©AANS, 2014. Source

Davis R.J.,Greater Baltimore Neurosurgical Associates | Nunley P.D.,Spine Institute of Louisiana | Kim K.D.,University of California at Davis | Hisey M.S.,The Texas Institute | And 6 more authors.
Journal of Neurosurgery: Spine

OBJECT: The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up. METHODS: A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the US. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery. RESULTS: At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure. CONCLUSIONS: Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels. ©AANS, 2015. Source

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