Study Design. Prospective, single-site, randomized, Food and Drug Administration–approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices.
Objective. 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.
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.
Methods. 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.
Results. 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.
Conclusion. 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. 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.
Level of Evidence: 1
Cervical arthroplasty has been shown to be a safe and effective treatment for degenerative cervical disc disorders. Our results from 2 device studies document very late complications occurring beyond the routine follow-up interval for most patients who underwent cervical fusion. Extended follow-up for patients who underwent cervical arthroplasty should be considered
From the Oregon Neurosurgery Specialists, Springfield, OR.
Address correspondence and reprint requests to Robert J. Hacker, MD, Oregon Neurosurgery Specialists, 3355 Riverbend Drive, Springfield, OR 97477; E-mail: email@example.com
Acknowledgment date: August 6, 2013. First revision date: September 24, 2013. Acceptance date: September 25, 2013.
The device(s)/drug(s) is/are FDA-approved or approved by corresponding national agency for this indication.
The manuscript submitted does not contain information about medical device(s)/drug(s).
No funds were received in support of this work.