By a News Reporter-Staff News Editor at Politics & Government Week -- Data detailed on Clinical Research have been presented. According to news reporting originating from Springfield, Oregon, by VerticalNews correspondents, research stated, "Prospective, single-site, randomized, Food and Drug Administration.-approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices. To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices."
Our news editors obtained a quote from the research, "Summary of Background Data. Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less. Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction. Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms. Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed device-related complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures."
According to the news editors, the research concluded: "Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery."
For more information on this research see: Very Late Complications of Cervical Arthroplasty Results of 2 Controlled Randomized Prospective Studies From a Single Investigator Site. SPINE, 2013;38(26):2223-2226. SPINE can be contacted at: Lippincott Williams & Wilkins, 530 Walnut St, Philadelphia, PA 19106-3621, USA. (Lippincott Williams and Wilkins - www.lww.com; SPINE - journals.lww.com/spinejournal/pages/default.aspx)
The news editors report that additional information may be obtained by contacting F.M. Hacker, Oregon Neurosurg Specialists, Springfield, OR 97477, United States. Additional authors for this research include R.M. Babcock and R.J. Hacker.
Keywords for this news article include: Oregon, Surgery, Springfield, Arthroplasty, United States, Medical Devices, Clinical Research, Regulatory Agencies, Orthopedic Procedures, North and Central America, Clinical Trials and Studies, Government Agencies Offices and Entities
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