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Bryan artificial disc shown to preserve neck motion at two years postop
Investigators reported outcomes and complications similar to patients who underwent anterior cervical disc fusion.
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CHICAGO — Investigators conducting a prospective multicenter trial at seven centers in six European countries reported encouraging results using the Bryan prosthesis (Medtronic Sofamor Danek) for total cervical disc replacement at one and two years follow-up. The surgeons expressed some concern over the heterotopic ossification they saw in some cases.
“The clinical results are very good, comparable to anterior cervical disc fusion (ACDF). We had no device-related reinterventions or complications,” said Jan Goffin, MD, PhD, from the University Hospital Gasthuisberg in Leuven, Belgium.
Goffin, who for four years has followed 25 of his patients enrolled in the study, presented the collective study results at the North American Spine Society 19th Annual Meeting.
Researchers sought to determine whether the implant, which consists of two porous-coated titanium alloy shells and a contained synthetic nucleus, could relieve neurological symptoms and pain while providing patients with better neck function, range of motion and stability. Investigators also wanted to assess the implant’s safety.
One- and two-level implants
The 146 patients included in the study had cervical disc herniations or spondylotic changes at one or two levels (C3-C7), some with secondary radiculopathy and/or myelopathy. All participants first underwent at least six months of conservative treatment. Excluded were those with infections, pure axial neck pain, prior cervical surgery involving placement of implants or those whose cervical spines were considered unstable.
One hundred and three patients had the Bryan prosthesis implanted at one cervical level and 43 patients had it implanted at two levels. Researchers based results on such outcomes measures as the SF-36, the Cervical Spine Research Society questionnaire, an analysis of plain radiographs in flexion and extension, and Odom’s criteria, which ranks relief of preoperative symptoms as excellent, good, fair or poor.
At two years, the investigators analyzed postop results for 101 patients. Seventy-nine were treated at one level and 22 were treated at two levels.
Goffin said all of the patients showed improvement in their clinical outcomes based on the measures used. Based on Odom’s criteria, 64% of those treated at a single level and 59% treated at two levels had outcomes that were excellent.
These outcomes, he said, corresponded to results seen in similar patients who underwent ACDF based on what was reported in the literature.
For more information:
- Goffin J, Pointillart V, Lind B, et al. Two-year clinical results from a multicenter study of the Bryan cervical disc system. #84. Presented at the North American Spine Society 19th Annual Meeting. Oct. 27-30, 2004. Chicago.