Clinical outcomes of the Dynesys dynamic neutralization system: 1-year preliminary results
| Autor: | James Maxwell, Rick Delamarter, John Sherman, M. Mason Macenski, Tariq E. Awad, Boyle C. Cheng, Reginald J. Davis, Jeffrey Wingate, William C. Welch |
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| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Reoperation Sacrum medicine.medical_specialty Visual analogue scale Decompression Pilot Projects Investigational device exemption Degenerative disc disease Postoperative Complications Spinal Stenosis medicine Back pain Humans Patient participation Aged Lumbar Vertebrae business.industry General Medicine Middle Aged Decompression Surgical medicine.disease Surgery Radiography Clinical trial Spinal Fusion Treatment Outcome Physical therapy Female Neurology (clinical) Spondylolisthesis medicine.symptom business Low Back Pain Follow-Up Studies Retrolisthesis |
| Zdroj: | Neurosurgical Focus. 22:1-8 |
| ISSN: | 1092-0684 |
| Popis: | Object 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. |
| Databáze: | OpenAIRE |
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