Preliminary clinical experience with the Bryan Cervical Disc Prosthesis

摘要: OBJECTIVE: The concept of accelerated degeneration adjacent disc levels as a consequence increased stress caused by interbody fusion the cervical spine has been widely postulated. Therefore, reconstruction failed intervertebral with functional prosthesis should offer same benefits while simultaneously providing motion and thereby protecting level discs from abnormal stresses associated fusion. This study was designed to determine whether new can provide relief objective neurological symptoms signs, improve patient's ability perform activities daily living, decrease pain, stability normal range motion. METHODS: We conducted prospective, concurrently enrolled, multicenter trial Bryan Cervical Disc Prosthesis (Spinal Dynamics Corp., Mercer Island, WA) for treatment patients single-level degenerative disease spine. Patients symptomatic radiculopathy and/or myelopathy underwent implantation after standard anterior discectomy. At scheduled follow-up periods, effectiveness device characterized evaluating each function, at implanted level. RESULTS: Analysis included data regarding 60 6 months 30 those 1 year. Clinical success year 86 90%, respectively, exceeding study's acceptance criteria 85%. These results compare favorably short-term clinical outcomes discectomy reported in literature. year, there no measurable subsidence devices (based on measurement detection threshold 2 mm). Evidence posterior migration detected one patient suspected second patient. There evidence spondylotic bridging space. measured flexion-extension, determined an independent radiologist, ranged 21 degrees (mean motion, 9 +/- 5 degrees). No have explanted or surgically revised. CONCLUSION: Discectomy alleviates signs similar Radiographic supports procedure is safe recover quickly. Restrictive postoperative management not necessary. However, only long-term least years will it become clear remains functional, thus confirming these early favorable results. In addition, influence segments be assessed follow-up.