[Artificial Disc Replacement] A clinical analysis of 4- & 6-year follow-up results after cervical disc replacement surgery using the Bryan Cervical Disc Prosthesis (Free Full-text)

[Justin]

Journal of Neurosurgery: Spine. March 2010 Volume 12, Number 3

A clinical analysis of 4- and 6-year follow-up results after cervical disc replacement surgery using the Bryan Cervical Disc Prosthesis Clinical article

Jan Goffin, M.D., Ph.D.1, Johan van Loon, M.D., Ph.D.1, Frank Van Calenbergh, M.D.1, and Bailey Lipscomb, Ph.D.2. 1Department of Neurosurgery, Catholic University of Leuven, Belgium; and 2Medtronic Spinal and Biologics, Memphis, Tennessee.
Abbreviations used in this paper: ACDF = anterior cervical discectomy and fusion; MCS = Mental Component Summary; NDI = Neck Disability Index; PCS = Physical Component Summary; SF-36 = 36-Item Short Form Health Survey. ©1944-2010 by the American Association of Neurosurgeons

Object
In this study, long-term results are presented from clinical studies of the Bryan Cervical Disc Prosthesis at University Hospital Gasthuisberg in Leuven, Belgium. A total of 98 patients (89 with 1-level and 9 with 2-level implantations) agreed to participate in follow-up studies for up to 10 years postoperatively. This article focuses on the 4- and 6-year results. Patients in one of the clinical studies had either radiculopathy or myelopathy associated with spondylosis and/or disc herniations that did not respond to conservative treatment. Patients from the other clinical study received commercially available Bryan devices and the study protocol did not have specific inclusion/exclusion criteria. More than 90% of the patients were considered to have radiculopathy.

Methods
Clinical measurements discussed in the article include the 36-Item Short Form Health Survey, Neck Disability Index, numerical ratings of neck and arm pain, neurological outcomes, and Odom classification. Angular motion findings from lateral flexion-extension radiographs are also presented. The occurrence of adverse events and second surgeries are examined as an indicator of device safety.

Results
The clinical outcomes at 4 and 6 years postoperatively appear consistent with the previously reported results at 1 and 2 years postoperatively. The mean angular motion results at 4 and 6 years postoperatively for 1-level patients were 7.3 and 7.7°, respectively. Two-level patients had slightly less motion at 4 and 6 years postoperatively with mean caudad values of 5.7 and 6.0°, respectively, and cephalad values of 4.2 and 6.2°, respectively. Efforts were made to capture adverse events, regardless of their nature and relatedness to the study surgery. This effort resulted in a relatively high number of recorded events. However, only 6 patients experienced events that were judged by the investigator to be related, either possibly or definitely, to the Bryan device. These events included device migration, device removal, and hoarseness and vocal cord paralysis, as well as 3 cases involving pain and neurological symptoms. Eight patients underwent further neck surgery to treat symptoms.

Conclusions
The favorable clinical and angular motion outcomes that were previously noted at 1- and 2-years' follow-up after cervical disc replacement with the Bryan Cervical Disc Prosthesis appear to persist after 4 and 6 years of follow-up.

cervical disc degeneration; cervical disc arthroplasty; Bryan Cervical Disc Prosthesis; cervical spine

[sportsnut3007]

What a shocker!!! ADR is good. When will insurers start to cover this. I guess they feel like they wont last the lifetime so in the long run a simple fusion may be cheaper idk. Hopeful they start covering adrs more, especially with the new ones like the m6 and the ranier ones coming and others that look like they really do have a chance to last 20 plus years. I hope the new ones like ranier has and the 3df ones coming come very fast and are covered. Especially in the cervical area I would presume they would last a long time and if needed to be replaced could be done so since they have no keels. And again lets hope they get this mesoblast stuff asap as regeneration kicks tail and is just an injection, thus cheaper.