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Clinical Trial
. 2003 Aug;16(4):324-30.
doi: 10.1097/00024720-200308000-00003.

Partial disc replacement with the PDN prosthetic disc nucleus device: early clinical results

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Clinical Trial

Partial disc replacement with the PDN prosthetic disc nucleus device: early clinical results

Chan Shik Shim et al. J Spinal Disord Tech. 2003 Aug.

Abstract

The aim of this study was to evaluate the efficacy of the PDN prosthetic disc nucleus device for the treatment of chronic discogenic back pain caused by degenerative disc disease. Among the 48 patients who underwent nucleus replacement surgery from January 2001 through May 2002, 46 patients were followed >6 months. The mean Oswestry Disability Index score was 58.9% preoperatively, and it improved to 18% at the 1-year follow-up. Visual Analogue Pain Scale scores improved from a preoperative mean of 8.5 to 3.1 after 1 year. The mean Prolo Scale score also improved from 5.2 preoperatively to 7.2 at 1 year. Major complications included four cases of device migration, requiring revision surgery, and infection in one patient. According to MacNab's criteria, results were excellent in 5 patients (10.9%), good in 31 (67.4%), fair in 3 (6.5%), and poor in 7 (15.1%). The overall clinical success rate was 78.3%. Nucleus replacement with the PDN device seemed to be effective in treating patients with chronic discogenic back pain caused by degenerative disc disease.

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