Study design: Prospective, concurrently enrolled, multicenter trials of the Bryan Cervical Disc Prosthesis (Medtronic Sofamor Danek, Memphis, TN) were conducted for the treatment of patients with single-level and two-level (bi-level) degenerative disc disease of the cervical spine.
Objectives: The studies were designed to determine whether new functional intervertebral cervical disc prosthesis can provide relief from objective neurologic symptoms and signs, improve the patient's ability to perform activities of daily living, decrease pain, and maintain stability and segmental motion.
Summary of background data: 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 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.
Methods: Patients with symptomatic cervical radiculopathy and/or myelopathy underwent implantation with the Bryan prosthesis after a standard anterior cervical discectomy. At scheduled follow-up periods, the effectiveness of the device was characterized by evaluating each patient's pain, neurologic function, and radiographically measured range of motion at the implanted level.
Results: Clinical success for both studies exceeded the study acceptance criteria of 85%. At 1-year follow-up, the flexion-extension range of motion per level: Discectomy and implantation of the device alleviates neurologic symptoms and signs similar to anterior cervical discectomy and fusion. Radiographic evidence supports maintenance of motion. The procedure is safe and the patients recover quickly. At least 5 years of follow-up will be needed to assess the long-term functionality of the prosthesis and protective influence on adjacent levels.