|Titel||The Bryan Cervical Disc: wear properties and early clinical results. |
|Publication Type||Journal Article |
|Year of Publication||2004 |
|Authors||Anderson, PA, Sasso, RC, Rouleau, JP, Carlson, CS, Goffin, J |
|Journal||The spine journal : official journal of the North American Spine Society |
|Issue||6 Suppl |
|Date Published||2004 Nov-Dec |
|Abstract|| BACKGROUND CONTEXT: The rationale for motion preservation by disc replacement after anterior cervical discectomy is to diminish long-term morbidity secondary to adjacent segment degeneration. However, these disc prostheses will be subject to wear and its possible adverse consequences.
PURPOSE: Assess the in vitro and in vivo wear properties of the Bryan Cervical Disc and the early clinical results.
STUDY DESIGN: In vitro mechanical testing, caprine animal model and prospective European human trial.
OUTCOME MEASURE: In vitro mechanical testing used American Society for Testing and Materials standards to measure wear rates and debris. Caprine results were analyzed by histopathologic analysis by a blinded veterinary pathologist. Clinical outcomes were measured by Odoms's criteria, independent radiologic analysis and Short Form-36.
METHODS: In vitro wear testing in cervical spine simulator for up to 40 M cycles. Wear rates were determined and particles analyzed microscopically. The in vivo inflammatory response was studied in goats that had discectomy at C4-C5. They were sacrificed between 3 and 12 months and histopathologically were compared with controls who had fusions with titanium plates. A prospective clinical trial of 136 patients with minimum 1-year follow-up was analyzed using validated questionnaires and radiographs.
RESULTS: In vitro wear averaged approximately 1.76% by weight at 10 M cycles and 18% at 40 M cycles. Wear debris were present in the periprosthetic tissues in 4 of 11 animals without inflammatory response. The early clinical results were satisfactory in over 90% of patients.
CONCLUSION: The in vivo and in vitro wear properties are satisfactory for the expected duration of life of the prosthesis. The early clinical results are satisfactory and equal to fusion. |
|Alternate Journal||Spine J |
|Full Text|| |
|PubMed ID||15541681 |