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  • 1
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    Online Resource
    Health state utility of patients with single-level cervical degenerative disc disease: comparison of anterior cervical discectomy and fusion with cervical disc arthroplasty : Clinical article
    Journal of Neurosurgery Publishing Group (JNSPG) ; 2014
    In:  Journal of Neurosurgery: Spine Vol. 20, No. 5 ( 2014-05), p. 475-479
    Details
    In: Journal of Neurosurgery: Spine, Journal of Neurosurgery Publishing Group (JNSPG), Vol. 20, No. 5 ( 2014-05), p. 475-479
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1547-5654
    URL: Article
    DOI: 10.3171/2014.1.SPINE13718
    RVK:
    XA 55270.1
    Language: Unknown
    Publisher: Journal of Neurosurgery Publishing Group (JNSPG)
    Publication Date: 2014
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  • 2
    Online Resource
    Online Resource
    Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease : Clinical article
    Journal of Neurosurgery Publishing Group (JNSPG) ; 2012
    In:  Journal of Neurosurgery: Spine Vol. 17, No. 6 ( 2012-12), p. 493-501
    Details
    In: Journal of Neurosurgery: Spine, Journal of Neurosurgery Publishing Group (JNSPG), Vol. 17, No. 6 ( 2012-12), p. 493-501
    Abstract: The purpose of this study was to evaluate the long-term safety and effectiveness of the ProDisc-L total disc replacement (TDR) as part of an FDA-mandated postmarket approval study. This report summarizes the clinical findings after 5 years of follow-up. Methods Two hundred thirty-six patients were treated and followed up for 5 years; 161 TDRs and 75 fusions had been performed in these patients. The primary outcome was a 10-component success end point. Secondary outcome measures included neurological status, secondary surgery, Oswestry Disability Index (ODI), 36-Item Short Form Health Survey (SF-36), visual analog scale (VAS) assessing pain and satisfaction, radiographic data, narcotic use, activity, and recreation status. Patients were monitored through their 5-year postoperative visits under the FDA postmarket surveillance provisions in the original investigational device exemption approval. Results The overall follow-up rate at 5 years was 81.8%. Study success demonstrated that TDR was noninferior to fusion with a 12.5% margin (p = 0.0099). Both TDR and fusion treatment groups maintained significant improvement on the ODI at 5 years compared with baseline (p 〈 0.0001). Secondary surgeries at the index level were performed in 12% of fusion patients and 8% of TDR patients. Radiographically, none of the TDRs developed spontaneous fusion. The segmental range of motion following TDR remained within normal range, although it decreased by approximately 0.5° in years 3 to 5. The VAS pain scores decreased from preoperative values by 48% in both treatment groups at 5 years. Patient satisfaction remained high in both groups (77%), while the percentage of patients indicating that they would have the surgery again was higher in TDR patients (82.5%) than in fusion patients (68.0%). Conclusions Patients in both groups maintained significant improvement during the 5-year follow-up. The TDR group had significantly better improvement on some scales. Although TDR patients avoid the stiffness of fusion and are more satisfied than fusion patients, both fusion and TDR are reasonable surgical options in this specific patient population.
    Type of Medium: Online Resource
    ISSN: 1547-5654
    URL: Article
    DOI: 10.3171/2012.9.SPINE11498
    RVK:
    XA 55270.1
    Language: Unknown
    Publisher: Journal of Neurosurgery Publishing Group (JNSPG)
    Publication Date: 2012
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  • 3
    Online Resource
    Online Resource
    Clinical outcomes of the Dynesys dynamic neutralization system: 1-year preliminary results
    Journal of Neurosurgery Publishing Group (JNSPG) ; 2007
    In:  Neurosurgical Focus Vol. 22, No. 1 ( 2007-01), p. 1-8
    Details
    In: Neurosurgical Focus, Journal of Neurosurgery Publishing Group (JNSPG), Vol. 22, No. 1 ( 2007-01), p. 1-8
    Abstract: In this study the authors present the preliminary clinical outcomes of dynamic stabilization with the Dynesys spinal system as part of a multicenter randomized prospective Food and Drug Administration (FDA) investigational device exemption (IDE) clinical trial. Methods This study included 101 patients from six IDE sites (no participants were omitted from the analysis) who underwent dynamic stabilization of the lumbar spine with the Dynesys construct. Patient participation was based on the presence of degenerative spondylolisthesis or retrolisthesis (Grade I), lateral or central spinal stenosis, and their physician's determination that the patient required decompression and instrumented fusion for one or two contiguous spinal levels between L-1 and S-1. Participants were evaluated preoperatively, postoperatively at 3 weeks, and then at 3-, 6-, and 12-month intervals. The 100-mm visual analog scale was used to score both lower-limb and back pain. Patient functioning was evaluated using the Oswestry Disability Index (ODI), and the participants' general health was assessed using the Short Form-12 questionnaire. Overall patient satisfaction was also reported. One hundred one patients (53 women and 48 men) with a mean age of 56.3 years (range 27–79 years) were included. The mean pain and function scores improved significantly from the baseline to 12-month follow-up evaluation, as follows: leg pain improved from 80.3 to 25.5, back pain from 54 to 29.4, and ODI score from 55.6 to 26.3%. Conclusions The early clinical outcomes of treatment with Dynesys are promising, with lessening of pain and disability found at follow-up review. Dynesys may be preferable to fusion for surgical treatment of degenerative spondylolisthesis and stenosis because it decreases back and leg pain while avoiding the relatively greater tissue destruction and the morbidity of donor site problems encountered in fusion. However, long-term follow-up care is still recommended.
    Type of Medium: Online Resource
    ISSN: 1092-0684
    URL: Article
    DOI: 10.3171/foc.2007.22.1.8
    Language: Unknown
    Publisher: Journal of Neurosurgery Publishing Group (JNSPG)
    Publication Date: 2007
    detail.hit.zdb_id: 2026589-X
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  • 4
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    Online Resource
    Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion : Clinical article
    Journal of Neurosurgery Publishing Group (JNSPG) ; 2012
    In:  Journal of Neurosurgery: Spine Vol. 17, No. 6 ( 2012-12), p. 504-511
    Details
    In: Journal of Neurosurgery: Spine, Journal of Neurosurgery Publishing Group (JNSPG), Vol. 17, No. 6 ( 2012-12), p. 504-511
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1547-5654
    URL: Article
    DOI: 10.3171/2012.9.SPINE11717
    RVK:
    XA 55270.1
    Language: Unknown
    Publisher: Journal of Neurosurgery Publishing Group (JNSPG)
    Publication Date: 2012
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