Neurosurgery
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Multicenter Study Clinical Trial
Preliminary clinical experience with the Bryan Cervical Disc Prosthesis.
The concept of accelerated degeneration of adjacent disc levels as a consequence of increased stress caused by interbody fusion of the cervical spine has been widely postulated. Therefore, reconstruction of a failed intervertebral disc with a functional disc prosthesis should offer the same benefits as fusion while simultaneously providing motion and thereby protecting the adjacent level discs from the abnormal stresses associated with fusion. This study was designed to determine whether a new, functional intervertebral cervical disc prosthesis can provide relief from objective neurological symptoms and signs, improve the patient's ability to perform activities of daily living, decrease pain, and provide stability and normal range of motion. ⋯ Discectomy and implantation of the device alleviates neurological symptoms and signs similar to anterior cervical discectomy and fusion. Radiographic evidence supports normal range of motion. The procedure is safe and the patients recover quickly. Restrictive postoperative management is not necessary. However, only after long-term follow-up of at least 5 years will it become clear whether the device remains functional, thus confirming these early favorable results. In addition, the influence on adjacent motion segments can be assessed after at least 5 years of follow-up.