Prosthetic disc nucleus (PDN) replacement for lumbar disc herniation: preliminary report with six months' follow-up.

Abstract

A clinical follow-up study was performed to evaluate lumbar disc nucleus replacement clinically and functionally. The objective was to assess the clinical efficacy of the prosthetic disc nucleus (PDN) for treatment of lumbar disc herniation. The PDN was designed to treat patients suffering from disc herniation and/or degeneration. Clinical trials for PDN were first conducted in 1996, and the results showed that the PDN device was effective in most of the patients who were implanted. These studies had been carried out with patients who were implanted with a pair of the devices. The main complication was device migration. Therefore, a follow-up study based on a single PDN device implantation was designed to evaluate its clinical result. Forty-five patients with lumbar disc herniation were implanted with one PDN device from March 2002 to December 2002. Thirty (66.7%) patients came to the clinical, functional, and radiographic 6-month follow-up examinations. Independent analysis was performed by careful review of the charts, operative notes, preoperative and postoperative radiographs, magnetic resonance images, and follow-up records of all patients. After implantation, significant proportions of patients experienced pain relief. Improvements were noted in pain intensity, walking distance, lumbar mobility, neurologic weakness, Oswestry and Prolo scores, and intervertebral disc height. No difference in work status after PDN implantation could be detected. Compared with the preoperative height, the intervertebral disc had gained 19.7% (P < 0.001). Device migration, failure, and dislocation were not noticed in any patient. A few patients had minor complications such as transient low-grade fever. Clinically, a single PDN is preferred and can effectively increase the height of the intervertebral disc in patients with lumbar disc herniation. However, long-term follow-up of PDN implantation needs to be studied.