Intermediate follow-up after treatment of degenerative disc disease with the Bryan Cervical Disc Prosthesis: single-level and bi-level.
METHODS
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.


OBJECTIVE
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.


BACKGROUND
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.
Goffin
Jan
J
Department of Neurosurgery, University Hospital, Leuven, Belgium. jan.goffin@uz.kuleuven.ac.be
Van Calenbergh
Frank
F
van Loon
Johannes
J
Casey
Adrian
A
Kehr
Pierre
P
Liebig
Klaus
K
Lind
Bengt
B
Logroscino
Carlo
C
Sgrambiglia
Rosella
R
Pointillart
Vincent
V
D000328:Adult; D000368:Aged; D002574:Cervical Vertebrae / Q000000981:diagnostic imaging / Q000601:surgery*; D017586:Diskectomy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007403:Intervertebral Disc / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009068:Movement; D009460:Neurologic Examination; D019736:Prostheses and Implants; D011788:Quality of Life; D011859:Radiography; D013122:Spinal Diseases / Q000175:diagnosis / Q000000981:diagnostic imaging / Q000601:surgery*